Complications and Risk Factors Associated with Explantation of Artificial Urinary Sphincter for Post-Prostatectomy Incontinence: A Nationwide French Study Using the PMSI Database

Complications and Risk Factors Associated with Explantation of Artificial Urinary Sphincter for Post-Prostatectomy Incontinence: A Nationwide French Study Using the PMSI Database | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Complications and Risk Factors Associated with Explantation of Artificial Urinary Sphincter for Post-Prostatectomy Incontinence: A Nationwide French Study Using the PMSI Database Charles MORGADO ORSINI, Alicia Blondeau, Alice PITOUT, Jean-Luc GAUDRY, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8824004/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 6 You are reading this latest preprint version Abstract Background The artificial urinary sphincter (AUS) is the reference surgical treatment for moderate-to-severe post-prostatectomy stress urinary incontinence. Despite durable functional outcomes, long-term device-related morbidity and explantation remain frequent. Nationwide real-world data jointly assessing postoperative complications and determinants of revision after AUS implantation remain limited. This study aimed to provide a comprehensive national overview of postoperative complications and identify risk factors for AUS revision or explantation. Methods We conducted a retrospective nationwide cohort study using the French Programme de Médicalisation des Systèmes d’Information (PMSI). All men undergoing primary AUS implantation after radical prostatectomy between 2017 and 2019 were included and followed until December 2023. Postoperative complications were identified using International Classification of Diseases, 10th (ICD-10) Revision codes and classified according to postoperative timing. Baseline comorbidities were analysed using univariate logistic regression, while post-implantation procedures were assessed using Poisson regression to estimate incidence rate ratios for revision or explantation. Results Among 1,790 patients, 268 (15.0%) underwent AUS explantation during follow-up. Most complication-coded rehospitalisations occurred during late follow-up. Urinary incontinence–related diagnoses were the most frequent events, whereas mechanical and infectious complications represented the most clinically relevant device-related outcomes. Urethral fragility conditions were the strongest predictors of explantation. Metabolic disorders, malnutrition, prior pelvic radiotherapy, anticoagulant therapy, tobacco use, and invasive procedures—including blood transfusion, indwelling catheterisation, and cystoscopy—were significantly associated with higher revision risk. Conclusion This nationwide PMSI-based study provides a comprehensive real-world assessment of postoperative morbidity and explantation risk after AUS implantation, highlighting the importance of optimised patient selection and cautious postoperative urethral instrumentation. Artificial urinary sphincter Post-prostatectomy incontinence Revision surgery Risk factors Figures Figure 1 Figure 2 Introduction Stress urinary incontinence (SUI) remains one of the most challenging complications after radical prostatectomy, with reported rates ranging from 5% to 60% depending on surgical technique, patient characteristics, and follow-up duration [ 1 , 2 ]. When conservative management fails, surgery is recommended. Among available options, the artificial urinary sphincter (AUS) has been the reference treatment for moderate-to-severe male SUI for more than four decades [ 3 , 4 ]. Meta-analyses demonstrate higher dryness rates with the AUS compared with male slings [ 5 ]. Despite durable functional outcomes, device-related complications remain frequent over long-term follow-up. Large institutional series report 10-year revision-free survival rates of 40–60%, mainly related to mechanical failure, urethral atrophy, erosion, or infection [ 6 ]. At the national level, a French nationwide “Programme de Médicalisation des Systèmes d’Information“ (PMSI) based study of 8,475 implantations reported reintervention-free survival rates of 71% at 2 years and 40% at 10 years, with a cumulative reoperation risk of 29% [ 7 ]. Several patient-related factors influence outcomes. Diabetes, obesity, smoking, advanced age, and anticoagulant therapy are associated with increased risks of erosion, infection, and explantation [ 8 , 9 ]. Prior pelvic radiotherapy remains one of the strongest predictors of early erosion and infection, doubling the likelihood of device removal [ 10 ]. Procedure-related factors also contribute: fragile urethral conditions, transcorporal cuff placement, and small cuff size increase erosion or atrophy risk [ 11 – 13 ], while institutional experience and revision strategy significantly affect long-term device survival [ 14 , 15 ]. Using the French nationwide PMSI, this study provides a national overview of postoperative complications after AUS implantation and identifies comorbidity- and procedure-related risk factors for revision or explantation in real-world practice. Methods Study design and data source We conducted a nationwide retrospective cohort study using the French PMSI database, which captures inpatient admissions in public and private hospitals for reimbursement. Diagnoses are coded using International “Classification of Diseases, 10th ” (ICD-10), while procedures and implanted devices are recorded using the “Classification Commune des Actes Médicaux” (CCAM) and the “Liste des Produits et Prestations” (LPP). The study received approval from the French data protection authority (CNIL, DE-2010-002), complied with the Declaration of Helsinki, and was registered with the Health Data Hub. Study population All men undergoing primary AUS implantation between January 1, 2017, and December 31, 2019, were identified using CCAM code JELA002. Inclusion was restricted to patients with a prior radical prostatectomy (laparoscopic, open retropubic, or perineal). Patients younger than 18 years and those with previous AUS implantation before 2017 were excluded. The implantation date defined the index hospitalization (T0). Follow-up extended until death or December 31, 2023. Baseline comorbidities were retrieved using ICD-10 codes recorded during the index hospitalization. These diagnoses provided an overview of medical conditions present at the time of AUS implantation. Outcomes Postoperative complications were identified from ICD-10 codes recorded during rehospitalizations and categorized into three periods: index hospitalization (T0), early postoperative period (≤ 3 months), and late follow-up (> 3 months). AUS revision or explantation was identified using CCAM codes for complete explantation, total replacement, or partial component exchange (cuff or pump/reservoir). Statistical analysis Patients were divided into two groups: those requiring AUS revision or explantation and those remaining revision-free. Baseline comorbidities were analyzed using univariate logistic regression, producing odds ratios (ORs) with 95% confidence intervals (CIs). Post-implantation procedures were analyzed using univariate Poisson regression, yielding incidence-rate ratios (IRRs), with group size used as an offset. Analyses were limited to exposures occurring at least 10 times per group, in accordance with French data-protection rules. All tests were two-sided, with p < 0.05 considered statistically significant. Results According to the national PMSI database, annual primary artificial urinary sphincter (AUS) implantations were stable from 2016 to 2023, except for a marked decline in 2020 related to the SARS-CoV-2 pandemic, with recovery by 2022 (Fig. 1A). Procedures were performed mainly in the private sector (46%), followed by public hospitals (41%) and ESPIC institutions (13%) (Fig. 1B). Postoperative outcomes Between January 1, 2017, and December 31, 2019, 1,790 men with prior radical prostatectomy underwent first-time artificial urinary sphincter (AUS) implantation for post-prostatectomy incontinence. All ICD-10 diagnoses recorded during index hospitalization (T0), early postoperative period (T1–T3, ≤ 3 months), and late follow-up (T4–T84, > 3 months) are summarized in Table 1 . Overall, 3,525 diagnosis-coded rehospitalization events were identified after primary AUS implantation. Of these, 1,990 events (56.5%) occurred during index admission, 255 (7.2%) during the early postoperative period, and 1,280 (36.3%) during late follow-up. Eighteen distinct ICD-10 entities were considered AUS-related complications (full list in Supplementary Table S1 ). Urinary incontinence was the most frequent complication. “Other specified urinary incontinence” (N39.4) accounted for 1,525 admissions, followed by stress urinary incontinence (N39.3; 646 admissions) and unspecified urinary incontinence (R32; 252 admissions). Mechanical complications of the urinary prosthesis (T83.1) represented 210 admissions, predominantly during late follow-up, while urinary retention (R33) accounted for 154 admissions across periods. Infectious complications included urinary tract infections, prosthesis-related infection or inflammation, sepsis, and systemic inflammatory response syndrome, mainly in the late phase. Hemorrhagic events comprised procedure-related hemorrhage or hematoma and hematuria. Less frequent complications included urethral stricture, pulmonary embolism, acute prostatitis, and dysuria. Table 1 Complications coded during rehospitalisation stratified by postoperative interval ICD‑10 Diagnostic label T0 (index) T1‑T3 (≤ 3 m) T4‑T84 (> 3 m) N394 Other specified urinary incontinence 1104 93 328 N393 Stress incontinence 496 27 123 R32 Unspecified urinary incontinence 177 28 47 T831 Mechanical complication of other urinary prosthetic devices and implants 18 38 154 R33 Retention of urine 57 24 73 N390 Urinary tract infection, site not specified 50 14 80 R10 Abdominal and pelvic pain 22 0 114 T810 Haemorrhage and haematoma complicating a procedure, not elsewhere classified 42 13 55 T835 Mechanical complication of other internal prosthetic devices, implants and grafts 0 18 71 R31 Unspecified haematuria 0 0 55 R65 Systemic inflammatory response syndrome (SIRS) 0 0 50 A41 Other sepsis 0 0 50 N35 Urethral stricture 13 0 15 R57 Shock, not elsewhere classified 0 0 25 I26 Pulmonary embolism 0 0 14 N410 Acute prostatitis 0 0 13 N358 Other urethral stricture 0 0 13 R30 Pain on micturition 11 0 0 AUS revision or explantation Of the 1,790 men who underwent AUS implantation, 268 (15%) required explantation, while 1,522 (85%) remained revision-free over the 84-month follow-up. No removals occurred within the first 6 months. Revisions peaked between 13 and 36 months, accounting for 124 cases (46.2%), and became rare beyond 5 years, with Fig. 2 AUS revision by time intervals only 28 events (Fig. 2). Overall, 284 baseline ICD-10 comorbidities were identified; for clarity, 16 clinically relevant codes are shown in Table 2 (full list in supplementary Table S2). Twelve were significantly associated with explantation. Metabolic and systemic factors included diabetes (OR 1.46), malnutrition (OR 1.96), obesity (OR 1.52), and hypertension (OR 1.47). Urological conditions showed the strongest associations, notably urethral stricture (OR 3.64), urethral fistula (OR 6.12), pelvic or urinary trauma (OR 12.11), and catheter-related complications (OR 3.39). Additional risk factors included beta-lactam resistance (OR 2.29), prior radiotherapy (OR 1.70), anticoagulant therapy (OR 1.70), and tobacco use (OR 1.74). Alcohol use disorder, atherosclerosis, COVID-19, and caregiver dependence were not significant. Table 3 displays the 3 CCAM procedures we deemed most clinically relevant (full list in supplementary Table S3). Blood transfusion was strongly associated with subsequent AUS revision (IRR 2.47), as were indwelling urethro-vesical catheter placement (IRR 3.25) and flexible urethro-cystoscopy, which showed the highest relative increase in revision risk (IRR 3.24; all p < 0.001). Discussion To our knowledge, this is the first nationwide PMSI-based study to jointly assess postoperative complications and risk factors for revision after artificial urinary sphincter implantation within a single national cohort. Building on prior work focused on reintervention [ 7 ] and validated PMSI methodology [ 16 , 17 ], our analysis integrates morbidity and comorbidity profiles, providing a comprehensive real-world assessment of AUS safety and outcomes. Temporal trends Device utilization trends confirm the AUS as the reference treatment for moderate-to-severe post-prostatectomy incontinence. Implantations declined sharply during the 2020 COVID-19 lockdown but rebounded within two years, consistent with national urological trends [ 7 ]. Meta-analyses demonstrating superior dryness and quality-of-life outcomes further support its leading role [ 18 , 20 ]. Postoperative complications Persistent or recurrent urinary incontinence was the leading cause of rehospitalization after AUS implantation. Incontinence-related ICD-10 codes (N39.4, N39.3, R32) accounted for 2,423 readmissions, representing 68.7% of complication-coded events. Most were recorded during the index hospitalization (T0); however, coding likely reflects the preoperative indication rather than a true postoperative complication. By contrast, 21.8% of incontinence-related events occurred beyond 3 months, suggesting persistent or recurrent symptoms. Early postoperative leakage does not necessarily indicate device failure. The AUS is routinely deactivated for 4–6 weeks after implantation, during which urinary leakage is expected and reflects the absence of active urethral occlusion during healing [ 3 , 4 ]. Within the PMSI database, urgency and urge urinary incontinence were inferred from codes N39.4 and R32. Although these administrative codes cannot distinguish sphincteric from bladder-related mechanisms, they likely capture mixed incontinence or urgency-predominant symptoms, possibly reflecting de novo detrusor overactivity after AUS implantation [ 9 ]. These findings align with published series reporting persistent leakage or pad use in 10–30% of patients during long-term follow-up despite a functioning device [ 6 , 18 , 20 ]. Reported pad-free continence rates range from 60% to 80%, with some patients requiring a single “security” pad [ 3 , 5 ]. Mechanical complications (T83.1/T83.5) and infections (N39.0, A41, R65) were the most clinically relevant device-related events, consistent with prior studies identifying erosion and infection as the main drivers of revision [ 7 , 8 , 11 ]. Hemorrhagic (3.1%) and thromboembolic complications were rare, in line with existing literature [ 6 , 20 ]. ICD-10–based risk factors for AUS explantation Urethral stricture (OR 3.64) and urethral fistula (OR 6.12) were the strongest predictors of explantation, confirming urethral fragility as the key risk factor for erosion [ 11 ]. Metabolic disorders, including diabetes (OR 1.46) and obesity (OR 1.52), significantly increased explantation risk, consistent with impaired healing and higher infection rates [ 8 ]. Malnutrition (OR 1.96) emerged as an independent determinant, in line with data linking hypoalbuminemia to adverse outcomes [ 21 ]. Prior pelvic radiotherapy increased removal risk by 70%, corroborating multicenter evidence [ 11 ]. Tobacco use and anticoagulant therapy were also significant [ 9 ]. Finally, beta-lactam resistance (OR 2.29) was associated with explantation, although robust data remain limited [ 22 ]. CCAM-linked risk factors for AUS explantation Among procedural exposures, blood transfusion was associated with a more than twofold higher revision risk (IRR 2.47), likely reflecting perioperative complexity rather than causality. Indwelling urethral catheterization (IRR 3.25) and repeated cystoscopies (IRR 3.24) were also strongly associated, consistent with evidence that iatrogenic instrumentation contributes to up to half of erosions. These findings underscore the importance of strict adherence to guideline-recommended precautions during urethral manipulation in AUS patients [ 23 , 24 ]. Strengths and limitations of a medico-administrative design The PMSI captures nearly all inpatient stays in France, providing exceptional sample size and external validity, but is designed for reimbursement rather than research. Complications linked to higher Diagnosis-Related Group tariffs may be preferentially coded, whereas clinically relevant but non-billable events can be underreported [ 25 ]. Privacy regulations preclude analysis of cells with fewer than ten patients, limiting analyses to descriptive and bivariate approaches. Moreover, CCAM data report aggregate procedure counts only, allowing high-utilizer patients to disproportionately influence rates. Finally, key surgical variables such as cuff size, antibiotic strategy, and surgeon volume are unavailable, limiting risk adjustment. Conclusions This nationwide PMSI-based study provides a comprehensive overview of complications and explantation risk after AUS implantation in France. Urethral fragility, metabolic and infectious comorbidities, radiotherapy, and invasive procedures were key predictors. These findings support improved patient selection, risk-factor optimization, and postoperative management to enhance long-term AUS outcomes. Declarations Ethics approval and consent to participate : This study was conducted using anonymized medico-administrative data from the French PMSI database. No direct patient involvement occurred. The study received approval from the French data protection authority (CNIL, DE-2010-002), complied with the Declaration of Helsinki, and was registered with the Health Data Hub. Funding The authors received no specific funding for this work. Author Contribution C.Mo. and C.Ma. wrote the main manuscript text.JL.G. and H.B. contributed to the acquisition of the dataP.E. and C.Ma. supervised the manuscript preparation.C.Mo., A.B. , and A.P. contributed to data analysis and to the preparation of Tables 1 and 2.C.Mo. prepared figures 1-2.All authors reviewed the manuscript. References Capogrosso P, Sanchez-Salas R, Salonia A, Montorsi F, Briganti A (2016) Urinary continence recovery after radical prostatectomy: pathophysiologic rationale and surgical modifications to improve outcome. Expert Rev Anticancer Ther 16(5):543–556. 10.1586/14737140.2016.1160794 Gacci M, Falcone M, Giannakis J, Saleh O, Serni S (2023) Latest evidence on post-prostatectomy incontinence: pathophysiology, evaluation, and management. J Clin Med 12(3):1190. 10.3390/jcm12031190 Suarez OA, McCammon KA (2016) The artificial urinary sphincter in the management of incontinence in males. 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J Urol 180(6):2475–2478. 10.1016/j.juro.2008.08.021 Ivan SJ, Cohn JA, Loh-Doyle JC, Lentz AC, Simhan J (2025) Cuff conundrums: best practice recommendations for urethral instrumentation with an artificial urinary sphincter in place. J Urol 213(3):271–273. 10.1097/JU.0000000000004312 Seideman CA, Zhao LC, Hudak SJ, Mierzwiak J, Adibi M, Morey AF (2013) Is prolonged catheterization a risk factor for artificial urinary sphincter cuff erosion? Urology 82(4):943–946. 10.1016/j.urology.2013.06.044 Georgescu D et al (2010) Coding accuracy in medico-administrative databases for urological procedures. Health Serv Res 45:1376–1391. 10.1111/j.1475-6773.2010.01143.x Tables Tables 2 and 3 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table2.ICD10riskfactorsforAUSrevision.png Table 2 ICD-10 risk factors for AUS revision Table3.CCAMriskfactorsforAUSrevision.png Table 3. CCAM risk factors for AUS revision Supplementaryappendix.docx Supplementary Tables S1–S3 are available online. Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 05 May, 2026 Reviewers agreed at journal 13 Apr, 2026 Reviewers invited by journal 13 Apr, 2026 Editor assigned by journal 14 Feb, 2026 Submission checks completed at journal 14 Feb, 2026 First submitted to journal 08 Feb, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8824004","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":624503696,"identity":"95c041d8-9389-4f55-8395-3f3c141b5856","order_by":0,"name":"Charles MORGADO ORSINI","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABFUlEQVRIiWNgGAWjYDACCSB+AOexMcjBmPx4tSQgaTGGMSUbiNWSCFOJUwv/7OZnHxIq6hh023sfv/hRZpPeL3342cMvFQwS5jj0SNw5Zjwj4cxhBrMzx80se86l5c7sSzM3ljnDICFzALsWA4kEY4bEtgMMZjfS2Ax42w7nbjjDYCYt2cZQJ4HDYQYS6Z8ZEv/VgbUY/m07nG5whv2btOQ/BgncWnKAtjQwg7QwPwbakmBwhsdM8mMDbi0SN3KKGRKOHeYxO3OMjVnmXJrhzB6eMmmGYxI4tfDPSN/M8KGmTs7seBvzxzdlNvL8POzbJH/U2ODUAgM8QMwGV8TMw0BIA1ThBxiL8QdRGkbBKBgFo2CEAADuk1PmpaZbswAAAABJRU5ErkJggg==","orcid":"","institution":"Centre Hospitalier Universitaire de Nancy","correspondingAuthor":true,"prefix":"","firstName":"Charles","middleName":"MORGADO","lastName":"ORSINI","suffix":""},{"id":624503697,"identity":"4982fe07-e7a1-4c4c-b18b-dffd4fa50071","order_by":1,"name":"Alicia Blondeau","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Nancy","correspondingAuthor":false,"prefix":"","firstName":"Alicia","middleName":"","lastName":"Blondeau","suffix":""},{"id":624503698,"identity":"2dd9aec3-acfc-461e-a7dc-b640170aee5a","order_by":2,"name":"Alice PITOUT","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Nancy","correspondingAuthor":false,"prefix":"","firstName":"Alice","middleName":"","lastName":"PITOUT","suffix":""},{"id":624503699,"identity":"9027b8b8-7dd2-4a17-927b-1749694a7ae4","order_by":3,"name":"Jean-Luc GAUDRY","email":"","orcid":"","institution":"Tekkare","correspondingAuthor":false,"prefix":"","firstName":"Jean-Luc","middleName":"","lastName":"GAUDRY","suffix":""},{"id":624503700,"identity":"9e8eff57-d0f4-444b-b779-50badcd4d0bf","order_by":4,"name":"Hyunji BYUN","email":"","orcid":"","institution":"Tekkare","correspondingAuthor":false,"prefix":"","firstName":"Hyunji","middleName":"","lastName":"BYUN","suffix":""},{"id":624503701,"identity":"68217b6a-1df7-4797-806a-91e9bacd41fb","order_by":5,"name":"Pascal ESCHWEGE","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Nancy","correspondingAuthor":false,"prefix":"","firstName":"Pascal","middleName":"","lastName":"ESCHWEGE","suffix":""},{"id":624503702,"identity":"032d3227-79dc-4465-91fd-faeba4917c20","order_by":6,"name":"Charles MAZEAUD","email":"","orcid":"","institution":"Centre Hospitalier Universitaire de Nancy","correspondingAuthor":false,"prefix":"","firstName":"Charles","middleName":"","lastName":"MAZEAUD","suffix":""}],"badges":[],"createdAt":"2026-02-08 20:09:13","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8824004/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8824004/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":107356239,"identity":"b62bf93d-53b7-4bf7-95a8-59ba922be0e9","added_by":"auto","created_at":"2026-04-20 16:57:49","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":137833,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCharacteristics of patients receiving AUS implantation in France\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(A) Annual number of primary implantations, 2016‑2023; (B) Distribution of procedures by hospital categories.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8824004/v1/9f6cd24b4e856c3a680c7158.png"},{"id":107486183,"identity":"1bdea09e-056f-486d-a054-2038f042f8e3","added_by":"auto","created_at":"2026-04-22 02:37:40","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":29971,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eAUS revision by time intervals\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8824004/v1/de184bc73c2526b53d1179b7.png"},{"id":109405834,"identity":"fe236bd3-9a5c-4c38-b843-76da457a03df","added_by":"auto","created_at":"2026-05-17 13:20:25","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":327640,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8824004/v1/2faef7d1-9e2d-49bc-93c7-29858d8af524.pdf"},{"id":107484659,"identity":"b44a83e2-e08f-4d63-a3c4-45bf3ea7bbc5","added_by":"auto","created_at":"2026-04-22 02:32:39","extension":"png","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":128417,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTable 2 ICD-10 risk factors for AUS revision\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Table2.ICD10riskfactorsforAUSrevision.png","url":"https://assets-eu.researchsquare.com/files/rs-8824004/v1/38904d823401308ab99a06d2.png"},{"id":107484798,"identity":"38a93d4c-adf3-4058-866a-4547fc60121e","added_by":"auto","created_at":"2026-04-22 02:33:01","extension":"png","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":48587,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTable 3. CCAM risk factors for AUS revision\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Table3.CCAMriskfactorsforAUSrevision.png","url":"https://assets-eu.researchsquare.com/files/rs-8824004/v1/b14a768088fa3ee7969d3574.png"},{"id":107356242,"identity":"1fae5e09-d620-41a4-8935-65eb37217f10","added_by":"auto","created_at":"2026-04-20 16:57:49","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":56244,"visible":true,"origin":"","legend":"\u003cp\u003eSupplementary Tables S1–S3 are available online.\u003c/p\u003e","description":"","filename":"Supplementaryappendix.docx","url":"https://assets-eu.researchsquare.com/files/rs-8824004/v1/c00d031f2b7933fd393b52b1.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eComplications and Risk Factors Associated with Explantation of Artificial Urinary Sphincter for Post-Prostatectomy Incontinence: A Nationwide French Study Using the PMSI Database\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eStress urinary incontinence (SUI) remains one of the most challenging complications after radical prostatectomy, with reported rates ranging from 5% to 60% depending on surgical technique, patient characteristics, and follow-up duration [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. When conservative management fails, surgery is recommended. Among available options, the artificial urinary sphincter (AUS) has been the reference treatment for moderate-to-severe male SUI for more than four decades [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Meta-analyses demonstrate higher dryness rates with the AUS compared with male slings [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDespite durable functional outcomes, device-related complications remain frequent over long-term follow-up. Large institutional series report 10-year revision-free survival rates of 40\u0026ndash;60%, mainly related to mechanical failure, urethral atrophy, erosion, or infection [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. At the national level, a French nationwide \u0026ldquo;Programme de M\u0026eacute;dicalisation des Syst\u0026egrave;mes d\u0026rsquo;Information\u0026ldquo; (PMSI) based study of 8,475 implantations reported reintervention-free survival rates of 71% at 2 years and 40% at 10 years, with a cumulative reoperation risk of 29% [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSeveral patient-related factors influence outcomes. Diabetes, obesity, smoking, advanced age, and anticoagulant therapy are associated with increased risks of erosion, infection, and explantation [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Prior pelvic radiotherapy remains one of the strongest predictors of early erosion and infection, doubling the likelihood of device removal [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Procedure-related factors also contribute: fragile urethral conditions, transcorporal cuff placement, and small cuff size increase erosion or atrophy risk [\u003cspan additionalcitationids=\"CR12\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], while institutional experience and revision strategy significantly affect long-term device survival [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eUsing the French nationwide PMSI, this study provides a national overview of postoperative complications after AUS implantation and identifies comorbidity- and procedure-related risk factors for revision or explantation in real-world practice.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and data source\u003c/h2\u003e \u003cp\u003eWe conducted a nationwide retrospective cohort study using the French PMSI database, which captures inpatient admissions in public and private hospitals for reimbursement. Diagnoses are coded using International \u0026ldquo;Classification of Diseases, 10th \u0026rdquo; (ICD-10), while procedures and implanted devices are recorded using the \u0026ldquo;Classification Commune des Actes M\u0026eacute;dicaux\u0026rdquo; (CCAM) and the \u0026ldquo;Liste des Produits et Prestations\u0026rdquo; (LPP). The study received approval from the French data protection authority (CNIL, DE-2010-002), complied with the Declaration of Helsinki, and was registered with the Health Data Hub.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eStudy population\u003c/h3\u003e\n\u003cp\u003eAll men undergoing primary AUS implantation between January 1, 2017, and December 31, 2019, were identified using CCAM code JELA002. Inclusion was restricted to patients with a prior radical prostatectomy (laparoscopic, open retropubic, or perineal). Patients younger than 18 years and those with previous AUS implantation before 2017 were excluded. The implantation date defined the index hospitalization (T0). Follow-up extended until death or December 31, 2023.\u003c/p\u003e \u003cp\u003eBaseline comorbidities were retrieved using ICD-10 codes recorded during the index hospitalization. These diagnoses provided an overview of medical conditions present at the time of AUS implantation.\u003c/p\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003ePostoperative complications were identified from ICD-10 codes recorded during rehospitalizations and categorized into three periods: index hospitalization (T0), early postoperative period (\u0026le;\u0026thinsp;3 months), and late follow-up (\u0026gt;\u0026thinsp;3 months).\u003c/p\u003e \u003cp\u003eAUS revision or explantation was identified using CCAM codes for complete explantation, total replacement, or partial component exchange (cuff or pump/reservoir).\u003c/p\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003ePatients were divided into two groups: those requiring AUS revision or explantation and those remaining revision-free. Baseline comorbidities were analyzed using univariate logistic regression, producing odds ratios (ORs) with 95% confidence intervals (CIs). Post-implantation procedures were analyzed using univariate Poisson regression, yielding incidence-rate ratios (IRRs), with group size used as an offset. Analyses were limited to exposures occurring at least 10 times per group, in accordance with French data-protection rules. All tests were two-sided, with p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 considered statistically significant.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eAccording to the national PMSI database, annual primary artificial urinary sphincter (AUS) implantations were stable from 2016 to 2023, except for a marked decline in 2020 related to the SARS-CoV-2 pandemic, with recovery by 2022 (Fig.\u0026nbsp;1A). Procedures were performed mainly in the private sector (46%), followed by public hospitals (41%) and ESPIC institutions (13%) (Fig.\u0026nbsp;1B).\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003ePostoperative outcomes\u003c/h2\u003e \u003cp\u003eBetween January 1, 2017, and December 31, 2019, 1,790 men with prior radical prostatectomy underwent first-time artificial urinary sphincter (AUS) implantation for post-prostatectomy incontinence. All ICD-10 diagnoses recorded during index hospitalization (T0), early postoperative period (T1\u0026ndash;T3, \u0026le;\u0026thinsp;3 months), and late follow-up (T4\u0026ndash;T84, \u0026gt;\u0026thinsp;3 months) are summarized in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Overall, 3,525 diagnosis-coded rehospitalization events were identified after primary AUS implantation. Of these, 1,990 events (56.5%) occurred during index admission, 255 (7.2%) during the early postoperative period, and 1,280 (36.3%) during late follow-up. Eighteen distinct ICD-10 entities were considered AUS-related complications (full list in Supplementary Table \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eUrinary incontinence was the most frequent complication. \u0026ldquo;Other specified urinary incontinence\u0026rdquo; (N39.4) accounted for 1,525 admissions, followed by stress urinary incontinence (N39.3; 646 admissions) and unspecified urinary incontinence (R32; 252 admissions). Mechanical complications of the urinary prosthesis (T83.1) represented 210 admissions, predominantly during late follow-up, while urinary retention (R33) accounted for 154 admissions across periods.\u003c/p\u003e \u003cp\u003eInfectious complications included urinary tract infections, prosthesis-related infection or inflammation, sepsis, and systemic inflammatory response syndrome, mainly in the late phase. Hemorrhagic events comprised procedure-related hemorrhage or hematoma and hematuria. Less frequent complications included urethral stricture, pulmonary embolism, acute prostatitis, and dysuria.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComplications coded during rehospitalisation stratified by postoperative interval\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICD‑10\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDiagnostic label\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT0 (index)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eT1‑T3 (\u0026le;\u0026thinsp;3\u0026nbsp;m)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT4‑T84 (\u0026gt;\u0026thinsp;3\u0026nbsp;m)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN394\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOther specified urinary incontinence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1104\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e328\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN393\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStress incontinence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e496\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e123\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eR32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnspecified urinary incontinence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e177\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e47\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eT831\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMechanical complication of other urinary prosthetic devices and implants\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e154\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eR33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRetention of urine\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e73\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN390\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUrinary tract infection, site not specified\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e80\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eR10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAbdominal and pelvic pain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e114\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eT810\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHaemorrhage and haematoma complicating a procedure, not elsewhere classified\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e55\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eT835\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMechanical complication of other internal prosthetic devices, implants and grafts\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e71\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eR31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUnspecified haematuria\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e55\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eR65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSystemic inflammatory response syndrome (SIRS)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e50\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eA41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOther sepsis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e50\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUrethral stricture\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eR57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eShock, not elsewhere classified\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e25\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePulmonary embolism\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN410\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAcute prostatitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eN358\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eOther urethral stricture\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eR30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePain on micturition\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eAUS revision or explantation\u003c/h3\u003e\n\u003cp\u003eOf the 1,790 men who underwent AUS implantation, 268 (15%) required explantation, while 1,522 (85%) remained revision-free over the 84-month follow-up. No removals occurred within the first 6 months. Revisions peaked between 13 and 36 months, accounting for 124 cases (46.2%), and became rare beyond 5 years, with \u003cb\u003eFig.\u0026nbsp;2 AUS revision by time intervals\u003c/b\u003e\u003c/p\u003e \u003cp\u003eonly 28 events (Fig.\u0026nbsp;2).\u003c/p\u003e \u003cp\u003eOverall, 284 baseline ICD-10 comorbidities were identified; for clarity, 16 clinically relevant codes are shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e (full list in supplementary Table S2). Twelve were significantly associated with explantation. Metabolic and systemic factors included diabetes (OR 1.46), malnutrition (OR 1.96), obesity (OR 1.52), and hypertension (OR 1.47). Urological conditions showed the strongest associations, notably urethral stricture (OR 3.64), urethral fistula (OR 6.12), pelvic or urinary trauma (OR 12.11), and catheter-related complications (OR 3.39). Additional risk factors included beta-lactam resistance (OR 2.29), prior radiotherapy (OR 1.70), anticoagulant therapy (OR 1.70), and tobacco use (OR 1.74). Alcohol use disorder, atherosclerosis, COVID-19, and caregiver dependence were not significant.\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e displays the 3 CCAM procedures we deemed most clinically relevant (full list in supplementary Table S3). Blood transfusion was strongly associated with subsequent AUS revision (IRR 2.47), as were indwelling urethro-vesical catheter placement (IRR 3.25) and flexible urethro-cystoscopy, which showed the highest relative increase in revision risk (IRR 3.24; all p\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eTo our knowledge, this is the first nationwide PMSI-based study to jointly assess postoperative complications and risk factors for revision after artificial urinary sphincter implantation within a single national cohort. Building on prior work focused on reintervention [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] and validated PMSI methodology [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], our analysis integrates morbidity and comorbidity profiles, providing a comprehensive real-world assessment of AUS safety and outcomes.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eTemporal trends\u003c/h2\u003e \u003cp\u003eDevice utilization trends confirm the AUS as the reference treatment for moderate-to-severe post-prostatectomy incontinence. Implantations declined sharply during the 2020 COVID-19 lockdown but rebounded within two years, consistent with national urological trends [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Meta-analyses demonstrating superior dryness and quality-of-life outcomes further support its leading role [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003ePostoperative complications\u003c/h2\u003e \u003cp\u003ePersistent or recurrent urinary incontinence was the leading cause of rehospitalization after AUS implantation. Incontinence-related ICD-10 codes (N39.4, N39.3, R32) accounted for 2,423 readmissions, representing 68.7% of complication-coded events. Most were recorded during the index hospitalization (T0); however, coding likely reflects the preoperative indication rather than a true postoperative complication. By contrast, 21.8% of incontinence-related events occurred beyond 3 months, suggesting persistent or recurrent symptoms.\u003c/p\u003e \u003cp\u003eEarly postoperative leakage does not necessarily indicate device failure. The AUS is routinely deactivated for 4\u0026ndash;6 weeks after implantation, during which urinary leakage is expected and reflects the absence of active urethral occlusion during healing [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Within the PMSI database, urgency and urge urinary incontinence were inferred from codes N39.4 and R32. Although these administrative codes cannot distinguish sphincteric from bladder-related mechanisms, they likely capture mixed incontinence or urgency-predominant symptoms, possibly reflecting de novo detrusor overactivity after AUS implantation [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThese findings align with published series reporting persistent leakage or pad use in 10\u0026ndash;30% of patients during long-term follow-up despite a functioning device [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Reported pad-free continence rates range from 60% to 80%, with some patients requiring a single \u0026ldquo;security\u0026rdquo; pad [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eMechanical complications (T83.1/T83.5) and infections (N39.0, A41, R65) were the most clinically relevant device-related events, consistent with prior studies identifying erosion and infection as the main drivers of revision [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Hemorrhagic (3.1%) and thromboembolic complications were rare, in line with existing literature [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eICD-10\u0026ndash;based risk factors for AUS explantation\u003c/h2\u003e \u003cp\u003eUrethral stricture (OR 3.64) and urethral fistula (OR 6.12) were the strongest predictors of explantation, confirming urethral fragility as the key risk factor for erosion [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Metabolic disorders, including diabetes (OR 1.46) and obesity (OR 1.52), significantly increased explantation risk, consistent with impaired healing and higher infection rates [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Malnutrition (OR 1.96) emerged as an independent determinant, in line with data linking hypoalbuminemia to adverse outcomes [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Prior pelvic radiotherapy increased removal risk by 70%, corroborating multicenter evidence [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Tobacco use and anticoagulant therapy were also significant [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Finally, beta-lactam resistance (OR 2.29) was associated with explantation, although robust data remain limited [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eCCAM-linked risk factors for AUS explantation\u003c/h2\u003e \u003cp\u003eAmong procedural exposures, blood transfusion was associated with a more than twofold higher revision risk (IRR 2.47), likely reflecting perioperative complexity rather than causality. Indwelling urethral catheterization (IRR 3.25) and repeated cystoscopies (IRR 3.24) were also strongly associated, consistent with evidence that iatrogenic instrumentation contributes to up to half of erosions. These findings underscore the importance of strict adherence to guideline-recommended precautions during urethral manipulation in AUS patients [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eStrengths and limitations of a medico-administrative design\u003c/h2\u003e \u003cp\u003eThe PMSI captures nearly all inpatient stays in France, providing exceptional sample size and external validity, but is designed for reimbursement rather than research. Complications linked to higher Diagnosis-Related Group tariffs may be preferentially coded, whereas clinically relevant but non-billable events can be underreported [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Privacy regulations preclude analysis of cells with fewer than ten patients, limiting analyses to descriptive and bivariate approaches. Moreover, CCAM data report aggregate procedure counts only, allowing high-utilizer patients to disproportionately influence rates. Finally, key surgical variables such as cuff size, antibiotic strategy, and surgeon volume are unavailable, limiting risk adjustment.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThis nationwide PMSI-based study provides a comprehensive overview of complications and explantation risk after AUS implantation in France. Urethral fragility, metabolic and infectious comorbidities, radiotherapy, and invasive procedures were key predictors. These findings support improved patient selection, risk-factor optimization, and postoperative management to enhance long-term AUS outcomes.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eEthics approval and consent to participate :\u003c/h2\u003e \u003cp\u003eThis study was conducted using anonymized medico-administrative data from the French PMSI database. No direct patient involvement occurred. The study received approval from the French data protection authority (CNIL, DE-2010-002), complied with the Declaration of Helsinki, and was registered with the Health Data Hub.\u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThe authors received no specific funding for this work.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eC.Mo. and C.Ma. wrote the main manuscript text.JL.G. and H.B. contributed to the acquisition of the dataP.E. and C.Ma. supervised the manuscript preparation.C.Mo., A.B. , and A.P. contributed to data analysis and to the preparation of Tables 1 and 2.C.Mo. prepared figures 1-2.All authors reviewed the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eCapogrosso P, Sanchez-Salas R, Salonia A, Montorsi F, Briganti A (2016) Urinary continence recovery after radical prostatectomy: pathophysiologic rationale and surgical modifications to improve outcome. Expert Rev Anticancer Ther 16(5):543\u0026ndash;556. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1586/14737140.2016.1160794\u003c/span\u003e\u003cspan address=\"10.1586/14737140.2016.1160794\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGacci M, Falcone M, Giannakis J, Saleh O, Serni S (2023) Latest evidence on post-prostatectomy incontinence: pathophysiology, evaluation, and management. J Clin Med 12(3):1190. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3390/jcm12031190\u003c/span\u003e\u003cspan address=\"10.3390/jcm12031190\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuarez OA, McCammon KA (2016) The artificial urinary sphincter in the management of incontinence in males. 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Health Serv Res 45:1376\u0026ndash;1391. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/j.1475-6773.2010.01143.x\u003c/span\u003e\u003cspan address=\"10.1111/j.1475-6773.2010.01143.x\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 2 and 3 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjur","sideBox":"Learn more about [World Journal of Urology](https://link.springer.com/journal/345)","snPcode":"345","submissionUrl":"https://submission.nature.com/new-submission/345/3","title":"World Journal of Urology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Artificial urinary sphincter, Post-prostatectomy incontinence, Revision surgery, Risk factors","lastPublishedDoi":"10.21203/rs.3.rs-8824004/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8824004/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e \u003cb\u003eBackground\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThe artificial urinary sphincter (AUS) is the reference surgical treatment for moderate-to-severe post-prostatectomy stress urinary incontinence. Despite durable functional outcomes, long-term device-related morbidity and explantation remain frequent. Nationwide real-world data jointly assessing postoperative complications and determinants of revision after AUS implantation remain limited. This study aimed to provide a comprehensive national overview of postoperative complications and identify risk factors for AUS revision or explantation.\u003c/p\u003e \u003cp\u003e \u003cb\u003eMethods\u003c/b\u003e \u003c/p\u003e \u003cp\u003eWe conducted a retrospective nationwide cohort study using the French Programme de M\u0026eacute;dicalisation des Syst\u0026egrave;mes d\u0026rsquo;Information (PMSI). All men undergoing primary AUS implantation after radical prostatectomy between 2017 and 2019 were included and followed until December 2023. Postoperative complications were identified using International Classification of Diseases, 10th (ICD-10) Revision codes and classified according to postoperative timing. Baseline comorbidities were analysed using univariate logistic regression, while post-implantation procedures were assessed using Poisson regression to estimate incidence rate ratios for revision or explantation.\u003c/p\u003e \u003cp\u003e \u003cb\u003eResults\u003c/b\u003e \u003c/p\u003e \u003cp\u003eAmong 1,790 patients, 268 (15.0%) underwent AUS explantation during follow-up. Most complication-coded rehospitalisations occurred during late follow-up. Urinary incontinence\u0026ndash;related diagnoses were the most frequent events, whereas mechanical and infectious complications represented the most clinically relevant device-related outcomes. Urethral fragility conditions were the strongest predictors of explantation. Metabolic disorders, malnutrition, prior pelvic radiotherapy, anticoagulant therapy, tobacco use, and invasive procedures\u0026mdash;including blood transfusion, indwelling catheterisation, and cystoscopy\u0026mdash;were significantly associated with higher revision risk.\u003c/p\u003e \u003cp\u003e \u003cb\u003eConclusion\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThis nationwide PMSI-based study provides a comprehensive real-world assessment of postoperative morbidity and explantation risk after AUS implantation, highlighting the importance of optimised patient selection and cautious postoperative urethral instrumentation.\u003c/p\u003e","manuscriptTitle":"Complications and Risk Factors Associated with Explantation of Artificial Urinary Sphincter for Post-Prostatectomy Incontinence: A Nationwide French Study Using the PMSI Database","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-20 16:57:43","doi":"10.21203/rs.3.rs-8824004/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"84659240235230445001607405508439570137","date":"2026-05-05T06:34:38+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"325144854936356365088687261677871782557","date":"2026-04-13T11:10:47+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-13T07:38:08+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-02-14T18:50:43+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-02-14T16:43:16+00:00","index":"","fulltext":""},{"type":"submitted","content":"World Journal of Urology","date":"2026-02-08T19:48:12+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-urology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjur","sideBox":"Learn more about [World Journal of Urology](https://link.springer.com/journal/345)","snPcode":"345","submissionUrl":"https://submission.nature.com/new-submission/345/3","title":"World Journal of Urology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"b34e6528-247a-442a-94db-a1cbf64acbc3","owner":[],"postedDate":"April 20th, 2026","published":true,"recentEditorialEvents":[{"type":"reviewerAgreed","content":"84659240235230445001607405508439570137","date":"2026-05-05T06:34:38+00:00","index":27,"fulltext":""}],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-04-20T16:57:43+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-20 16:57:43","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8824004","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8824004","identity":"rs-8824004","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}