Composite Failure Associated With Sacrohysteropexy and Sacrocolpopexy With Supracervical Hysterectomy for Advanced Pelvic Organ Prolapse.

Hirotaka Sato, Kenji Sugita, and Shota Otsuka contributed to protocol/project development, data collection, data management, and data analysis. Hirotaka Sato, Hirokazu Abe, and Sachiyuki Tsukada were involved in manuscript writing/editing. All authors approved the final manuscript.

This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board (approval number: [2022‐080]).

Between October 2019 and February 2023, 321 patients diagnosed with stage III or IV prolapse underwent either SHP or SCH/SCP. Sixty patients (previous hysterectomy, n  = 51; lost to follow‐up, n  = 9) were excluded from the study. A total of 261 patients were eligible for analysis (SHP group, n  = 52; SCH/SCP group, n  = 209) (Figure  2 ). Patient enrollment in this study. SCH, supracervical hysterectomy; SCP, sacrocolpopexy; SHP, sacrohysteropexy. Table  1 summarizes the baseline demographic characteristics of the study groups. The SHP group exhibited significantly older age, higher Charlson comorbidity index values, and higher values of the most superior location of the front vaginal wall (Ba values) than those of the SCH/SCP group. No significant differences in CF (OR, 2.54; 95% CI, 0.80–7.48), SF (OR, 2.48; 95% CI, 0.37–13.3), and AF (OR, 1.76; 95% CI, 0.28–8.06) were observed between the SHP and SCH/SCP groups (Table  2 ). The incidence of POP‐Q stage II of the SHP group at 1 year was significantly higher than that of the SCH/SCP group ( p  = 0.017) (Table  2 ). There were no significant differences in the proportions of patients in the SHP and SCH/SCP groups who achieved a reduction of ≥ 45 points in the MCIC of PFDI‐20 (53% vs. 47%; OR, 1.27; 95% CI, 0.66–2.48) and a 15‐point reduction in each PFDI‐20 domain, namely, POPDI‐6 (61% vs. 65%; OR, 0.84; 95% CI, 0.43–1.68) (Table  2 ). Baseline demographics, clinical characteristics, and pelvic floor disorder questionnaire results. Note: Data are presented as the number (%) or median (IQR). Abbreviations: Ba, the most superior location of the front vaginal wall; BMI, body mass index; Bp, the uppermost point of the posterior vaginal wall; C, the lowest edge of the cervix; CCI, Charlson comorbidity index; IQR, interquartile range; PFDI, Pelvic Floor Disability Index; POP, pelvic organ prolapse; POPDI, Pelvic Organ Prolapse Distress Inventory; POP‐Q, Pelvic Organ Prolapse Quantification; SCH, supracervical hysterectomy; SCP, sacrocolpopexy; SHP, sacrohysteropexy; TVL, total vaginal length. Data regarding the preoperative PFDI‐20 scores of three patients are missing. Outcome data. Note: Data are shown as the median (IQR). Abbreviations: Ba, the most superior location of the front vaginal wall; Bp, the uppermost point of the posterior vaginal wall; C, the lowest edge of the cervix; CI, confidence interval; IQR, interquartile range; MCIC, minimal clinically important change; OR, odds ratio; PFDI, Pelvic Floor Disability Index; POP, pelvic organ prolapse; POP‐Q, Pelvic Organ Prolapse Quantification; SCH, supracervical hysterectomy; SCP, sacrocolpopexy; SHP, sacrohysteropexy; TVL, total vaginal length. Data regarding the MCIC scores of three patients are missing. Regarding repeat surgery, two patients in the SHP group underwent anterior and posterior colporrhaphy. In the SCH/SCP group, one patient underwent anterior colporrhaphy, one patient underwent posterior colporrhaphy, and one patient underwent repeat SCP for uterovaginal prolapse. The SCH/SCP group included one bladder injury, two vaginotomies, three surgical site infections (SSIs), five suture exposures, one mesh exposure, two port site hernias, and one case of spondylitis. In contrast, patients in the SHP group did not experience any of these complications (Table  2 ). The perioperative results indicated that patients who underwent SHP had shorter OTs than those of patients who underwent SCH/SCP (100 [84–113] minutes vs. 117 [100–134] minutes; p  < 0.001). The mean EBL of both groups was 10 mL (SHP group: 10.0 [5.0–10.0] mL; SCH/SCP group: 10.0 [10.0–20.0] mL; p  = 0.0021); however, this difference was not clinically significant (Table  3 ). Surgery and postoperative characteristics. CI, confidence interval; OR, odds ratio; SCH, supracervical hysterectomy; SCP, sacrocolpopexy; SHP, sacrohysteropexy. The logistic regression analysis revealed that a history of diabetes was a predictor of CF (OR, 4.45; 95% CI, 1.36–14.6; p  = 0.014). Additionally, SHP and SCH/SCP were compared to determine the risk of CF with SHP (OR, 1.21; 95% CI, 0.35–4.17). When IPTW was applied, the risk of CF with SHP was slightly lower than that with SCH/SCP (OR, 1.18; 95% CI, 0.40–3.44) (Table  4 ). Both analyses showed no significant difference in CF between groups. Factors associated with composite failure based on the logistic regression analysis with inverse probability of treatment weighting of data performed to compare SCH/SCP and SHP. Abbreviations: Ba, the most superior location of the front vaginal wall; BMI, body mass index; CI, confidence interval; IPTW, inverse probability of treatment weighting; MCIC, minimal clinically important change; OR, odds ratio; PFDI, Pelvic Floor Disability Index; POPDI, Pelvic Organ Prolapse Distress Inventory; POP‐Q, Pelvic Organ Prolapse Quantification; SCH, supracervical hysterectomy; SCP, sacrocolpopexy; SHP, sacrohysteropexy.

Our data suggested no difference in the CF rates associated with SHP and SCH/SCP when advanced POP repair was considered. However, the CF rate was 13.5% with SHP, which was more than double the rate observed with SCH/SCP (5.7%). This finding suggests potentially meaningful differences. Furthermore, no significant differences in SF, AF, and repeat surgery were observed between groups. According to the multivariate model adjusted for confounders, a comparison of SHP and SCH/SCP showed that the OR of CF with SHP was 1.21 (no significant difference). Additionally, according to the IPTW analysis, the OR of CF with SHP was 1.18 (no significant difference). Further research should be performed to determine whether an OR of 1.2 is clinically meaningful. A history of diabetes was a possible predictor of CF (OR, 4.45; significant difference). There were no significant differences in complications experienced by the SHP and SCH/SCP groups within 30 days and 1 year postoperatively. During a previous multicenter, retrospective cohort study, the SF rates at 1 year were 3.5% with SCH/SCP and 9.0% with SHP (no significant difference) [ 8 ]. However, a recent multicenter, retrospective cohort study that used propensity score matching revealed that the SF rates at 1 year were 2.2% with SCH/SCP and 18.2% with SHP (significant difference) [ 9 ]. Both of those studies defined SF as the presence of bulging and reported SF incidences that were consistent with our findings of 5.8% and 2.4% with SHP and SCH/SCP, respectively. Notably, we used a multivariate model adjusted for confounding factors to examine the rates of achieving the MCIC in each questionnaire and found no significant differences between groups. Similar findings were reported by previous studies [ 6 , 8 ] of the PFDI‐20 that did not identify significant differences between groups. Regarding AF at 1 year, a single‐center retrospective study reported rates of 21.1% with SHP and 14.1% with SCH/SCP [ 6 ]. During that study, AF in the apical compartment was defined as apical descent lower than half of the vaginal length, whereas AF in the anterior and posterior compartments was defined as POP‐Q stage 2 or higher. The rates of recurrence in the apical, anterior, and posterior compartments were 0%, 21.1% and 0%, respectively, in the SHP group; however, they were 0%, 7.7% and 6.4%, respectively, in the SCH/SCP group. In particular, regarding anterior compartment recurrence, the SHP and SCH/SCP groups exhibited recurrence rates of 7.7% and 2.4%, respectively, in the current study. Inserting the mesh in the proper position on the anterior vaginal wall is difficult during SHP; according to a previous study, this difficulty was a cause of anterior compartment recurrence [ 6 ]. The different POP‐Q cutoff values used to determine failure may have contributed to the discrepancy in the findings of anterior recurrence. At 1 year, stage 2 prolapse was more common in the SHP group. When stricter criteria for AF (i.e., stage 2 or more severe) were applied, the AF rates were 12% and 5.7% with SHP and SCH/SCP, respectively. All cases involving stage 2 recurrence in the SHP and SCH/SCP groups comprised anterior prolapse. Recently, the rates of repeat surgery for prolapse after SCP, SCH, total hysterectomy, and no hysterectomy were compared. During 2 years of follow‐up, the repeat surgery rates were 1.5% with SCH, 1.1% with total hysterectomy, 1.5% with no hysterectomy, and 3.8% with SHP [ 20 ]. However, our retrospective study identified a lower repeat surgery rate with SHP. Because of the nature of our study, the POP‐Q stage, surgical technique, and patient selection may have caused differences in repeat surgery rates. Regarding postoperative complications, a recent literature review estimated that the overall incidence of mesh exposure after minimally invasive SCP was low (average incidence, 3.5%; median follow‐up, 6–86 months) [ 21 ]. A previous retrospective study demonstrated that when the mesh was secured with braided sutures, the occurrence of suture erosion after SCP was as high as 10.82 after adjusting for relevant factors such as age and concomitant procedures [ 22 ]. We consistently used braided sutures; therefore, our rate of suture exposure could have been comparatively higher. Notably, in the current study, no complications, such SSIs, occurred within 30 days of SHP. Studies have linked morcellation in the retrieval bag during SCH with an increased risk of SSIs [ 23 ]. However, for our patients, the removed uterine tissue was placed in a collection bag and extracted using a cold knife. We plan to review more cases to determine whether our method impacted the SSI rate. A recent retrospective study revealed that anterior vaginal recurrence after SCP was significantly affected by diabetes, whereas CF was not significantly different between patients with and without diabetes [ 24 ]. The current study reported that a significant increase in insulin resistance in patients with diabetes after SCP may lead to a marked increase in hyperglycemia, which may result in an increased inflammatory response and impaired angiogenesis, thus leading to mesh complications. During this study, after adjusting for potential confounders, the presence of diabetes was the only significant predictor of CF (OR, 4.45). Compared to SCH/SCP, SHP is expected to reduce the OT and EBL [ 25 ]. During our study, significant differences in the OT and EBL were observed, but the difference in the EBL was not clinically significant. Closing the uterine artery at its origin may have reduced bleeding during SCH. This could potentially explain why there was no clinically significant difference in the EBL of the SCH/SCP and SHP groups. This study had several limitations. First, this was a retrospective study without randomization. Moreover, bias, particularly regarding the median age of both groups and severity of comorbidities, was introduced because the patients had the option of selecting their preferred surgery. Second, the postoperative assessors were not blinded, and the survey was conducted by the attending surgeon, which may have reduced the generalizability and internal validity of the results. Third, the presence or absence of diabetes was a patient‐reported complication during our study. We did not measure HbA1c at the time of postoperative recurrence; therefore, an evaluation of diabetes control over time was not possible. Fourth, there are several ways to perform these procedures, particularly SHP. The results of this study are applicable to only the technique used for SHP during this study. Notably, this study lacked sufficient statistical power, and the SHP group was small. However, a strength of this study was that consistent OR estimates were obtained through the sensitivity analysis with IPTW, thus highlighting the robustness of the data.

Considering the patient's preferences when determining which surgical procedure to perform is crucial. According to our data, choosing SHP rather than SCH/SCP may not change the risk of complications associated with advanced POP. However, SHP may be inferior in terms of CF. Furthermore, our study may have lacked sufficient statistical power to detect differences specific to SHP. Therefore, further research is necessary to determine definitive conclusions.

Although pelvic organ prolapse (POP) is not life‐threatening, it is a globally common medical condition that considerably affects the quality of life of women [ 1 ]. In the United States, the lifetime risk of requiring surgical intervention for stress urinary incontinence or POP by age 80 years is 20% [ 2 ]. Many urogynecologists view the uterus as a passive structure involved in POP progression [ 3 ]. Approximately one‐third of all hysterectomies are performed solely for POP repair of a healthy uterus [ 4 ], and the interest in uterus‐sparing POP surgery has increased. Approximately 31% to 60% of women in the United States who require POP repair prefer uterus‐preserving procedures that provide effective surgical outcomes [ 5 ]. Therefore, offering more alternatives that do not require hysterectomy would provide women with more practical choices that allow individually tailored POP repair plans [ 6 ]. Surgical treatment of POP associated with uterovaginal prolapse involves various approaches; therefore, its treatment is complex and challenging for urogynecologists [ 7 ]. Sacrocolpopexy (SCP), which is a minimally invasive technique, has different forms. Some studies have reported no significant differences in the anatomical and subjective outcomes at 1 year after laparoscopic sacrohysteropexy (SHP) and laparoscopic supracervical hysterectomy (SCH)/laparoscopic SCP [ 8 , 9 ]. However, others have reported that SCH/SCP is more effective than SHP [ 10 ]. Furthermore, one study reported that anatomical recurrence (anterior compartment) was more common with SHP, but that the subjective outcomes of SHP and SCH/SCP did not differ [ 6 ]. Therefore, the reported findings have been inconsistent. Additionally, the literature has suggested an association between SCH/SCP and an increased risk of prolapse recurrence [ 11 ]. A comprehensive analysis of whether the uterus should be preserved or partially removed has not been reported, and the available data are limited [ 6 , 8 ]. Furthermore, there are limited data regarding differences in postoperative recurrence after SHP and SCH/SCP for patients with advanced POP. Our primary aim was to compare the composite failure (CF) rates at 1 year after SHP and SCH/SCP for patients with advanced POP. Additionally, we assessed postoperative complications and analyzed factors that contribute to the risk of CF.

The authors declare no conflicts of interest.

This retrospective cohort study of human participants performed at Hokusuikai‐Kinen Hospital was conducted in accordance with the principles embodied in the Declaration of Helsinki and approved by the Institutional Review Board (approval number 2022‐080). The requirement for the acquisition of informed consent was waived because of the retrospective design of this study. The clinical outcomes of all patients were assessed at 1 year postoperatively. Medical records of consecutive patients who underwent SHP or SCH/SCP between October 2019 and February 2023 were reviewed. The inclusion criteria were age 18 years or older, preoperative Pelvic Organ Prolapse Quantification (POP‐Q) [ 12 ] stage III or worse, and symptomatic apical or multicompartmental prolapse. The exclusion criteria were previous hysterectomy, uterine cervical dysplasia, and endometrial disorders. Additionally, patients were required to have normal Papanicolaou test results and negative human papillomavirus test results within 1 year before treatment. The primary endpoint was the CF rate at 1 year. The secondary endpoints were complication rates within 30 days and 1 year postoperatively and Pelvic Floor Distress Inventory‐20 (PFDI‐20) [ 13 ] scores. CF was defined as anatomical failure (AF), subjective failure (SF), and repeated surgical treatment. AF was defined as the leading edge of any compartment beyond the hymen. SF was defined when the patients experienced any bothersome bulging that they could see or feel (response of 1 or higher; i.e., response of “not at all,” “somewhat,” “moderately,” or “quite a bit” bothered when answering PFDI‐20 question 3). Repeated surgical treatment included anterior and/or posterior colporrhaphy or repeated SCP. Postoperative complications were categorized according to the Clavien–Dindo surgical complication grading scale [ 14 ]. Mesh exposure was defined as “vaginal mesh visualized through separated vaginal epithelium” according to the International Urogynecological Association/International Continence Society joint classification system [ 15 ]. Patients' demographic data, including age, body mass index (BMI), and Charlson comorbidity index [ 16 ], were collected. Additionally, preoperative and postoperative POP‐Q stages and perioperative data, including the operative time (OT) and estimated blood loss (EBL), were obtained from the medical charts. Preoperatively, all patients completed the PFDI‐20. Differences in the symptom scores of the two groups between baseline and 1 year postoperatively were compared (a score of −45 was the minimal clinically important change [MCIC] for the PFDI‐20) [ 17 ]. We examined only one domain, Pelvic Organ Prolapse Distress Inventory‐6 (POPDI‐6), of the PFDI‐20 questionnaire (a score of −15 was the MCIC). The POP stage was defined as the most severe stage in the anterior, apical, and/or posterior vaginal compartments. The patients underwent a physical examination to diagnose AF and suture or mesh exposure during follow‐up. During the 1‐year follow‐up evaluation, the patients completed validated questionnaires, including the PFDI‐20. The examination was performed by a single surgeon (H.S.) at 1 month, 3 months, and 12 months, and then annually thereafter. At our institution, a preoperative cytological examination of the cervix and uterus was performed for all patients scheduled to undergo laparoscopic SCP. However, when the opening of the uterus was closed because of aging or other reasons, transvaginal ultrasound tomography was performed to confirm the absence of any abnormality of the endometrium before surgery. All surgeries were conducted by a trained urologist (H.S.) in accordance with our operative procedure [ 18 ]. Each step of SHP is presented in Figure  1 . The decision regarding whether to proceed with SHP or SCH/SCP was based on discussions with the patients during preoperative consultations. The patients were provided with thorough counseling that outlined the advantages and risks of each procedure. SHP was recommended for patients who strongly preferred uterus preservation, those who valued the sense of femininity or identity associated with having a uterus, and those who did not have benign or malignant uterine lesions such as myomas, polyps, or adenomyosis. The patients' preferences played a key role in the decision‐making process. Additionally, none of the patients had abnormal bleeding or abnormal cervical findings. SHP was allowed only for patients who agreed to undergo annual postoperative uterine cancer screening. The surgeon began by inserting a 12‐mm camera port in the umbilicus and maintaining pneumoperitoneum pressure of 12 mmHg. The first assistant used a 10‐mm flexible scope (Olympus, Tokyo, Japan) to examine the abdominal cavity. Next, the surgeon placed a 5‐mm port for the left hand just inside the left anterior superior iliac spine. Then, a 5‐mm port for the right hand was positioned at the midpoint between the camera port and the pubis. Finally, the first assistant inserted a 5‐mm port just inside the right anterior superior iliac spine. The vaginal wall was dissected anteriorly up to the bladder trigone and posteriorly up to the levator‐ani muscle. Two polypropylene mesh sheets (Polyform; Boston Scientific, Natick, MA, USA) were secured to the anterior and posterior vaginal walls using an eight‐point fixation technique with 3‐0 nonabsorbable braided polyester sutures (Tefdesser II; Kono Seisakusyo, Chiba, Japan) and 2‐0 sutures (Tefdesser), respectively. The sacral arm of the mesh was anchored to the anterior longitudinal ligament at the S1–S2 level with horizontally inserted 1‐0 non‐absorbable braided sutures (Tefdesser). For the SHP group, the right broad ligament was opened at the cervico‐uterine junction in a vascular‐free space outside the uterine artery, allowing the cephalic portion of the anterior mesh to pass through. Subsequently, the anterior and posterior mesh pieces were sutured to the anterior and posterior surfaces of the uterine cervix using three‐point 2‐0 non‐absorbable braided sutures. In contrast, the SCH/SCP procedure was performed using standard techniques; the peritoneum was sutured over the mesh using absorbable 2‐0 barbed sutures (Stratafix spiral monocryl plus knotless tissue control device; Ethicon Inc. Somerville, NJ, USA) For POP with stress incontinence, we consistently used a two‐step approach for mid‐urethral sling placement. (A) The right broad ligament is opened at the cervico‐uterine junction in the vascular free space outside the uterine artery. (B) Mesh is secured to the posterior vaginal wall using an eight‐point fixation technique with 2‐0 nonabsorbable braided polyester sutures. (C) The mesh is secured to the anterior vaginal wall using an eight‐point fixation technique with 3‐0 nonabsorbable braided polyester sutures. The right broad ligament is opened to allow the cephalic portion of the anterior mesh to pass through. The anterior mesh piece is sutured to the anterior surface of the uterine cervix using three‐point 2‐0 permanent sutures. (D) The sacral arm of the anterior mesh is secured to the anterior longitudinal ligament at the S1–S2 level using horizontally inserted 1‐0 non‐absorbable braided sutures. Continuous variables are presented as medians and interquartile ranges with the 95% confidence interval (CI), whereas categorical variables are expressed as frequencies and percentages. Other comparisons between study groups were performed using the chi‐squared test for categorical variables and Mann–Whitney U test for continuous variables. Logistic regression was performed to evaluate the multivariate model of CF after SHP and SCH/SCP. A logistic regression analysis of age, body mass index, parity, diabetes, and POP‐Q stages was performed, and the odds ratio (OR) and 95% CIs were determined to compare CF between the SHP and SCH/SCP groups. The percentage changes in the PFDI‐20 and POPDI‐6 scores between baseline and 1 year when the MCIC was achieved were calculated using a logistic regression model that included the same factors as those in the logistic model; the ORs and 95% CIs were determined to compare the treatment effects of SHP and SCH/SCP. Multiple imputations were used for all missing data (100 imputations). All tests were two‐sided, and statistical significance was set at p  < 0.05. All statistical analyses were performed using R (R Foundation for Statistical Computing, Vienna, Austria) and EZR software (Saitama Medical Center, Jichi Medical University, Saitama, Japan). A sensitivity analysis with inverse probability of treatment weighting (IPTW) [ 19 ] of the patients' demographics and clinical characteristics was conducted to reduce treatment selection bias and potential confounding factors.