{"paper_id":"6d84aa3d-d17d-4ed4-8360-9fc7b748eaad","body_text":"Abstract\nIntroduction and Hypothesis\nPelvic floor dysfunctions are common in women with endometriosis. Currently available assessment tools are limited to isolated domains that do not allow for a comprehensive multidimensional evaluation. This study aimed to develop and perform a preliminary validation of a multidimensional composite index for pelvic floor dysfunction based on both subjective and objective measures in women with endometriosis.\nMethods\nData were retrospectively analyzed from a previously established cohort of patients who received either medical or medical–surgical treatment for endometriosis. The PDCS comprises three domains (each transformed to a 0–100 scale): subjective anorectal dysfunction (Wexner constipation and incontinence scores), pelvic floor symptoms (PFDI-20), and objective anorectal function (manometric parameters). The score was calculated as the mean of the available domains and stratified into mild (0–33), moderate (34–66), and severe (67–100) dysfunction. Internal structure assessment was based on principal component analysis and Spearman correlations. Clinical validation was assessed by correlating with pain (EHP-30) and sexual function (FSFI).\nResults\nTwenty-nine patients with clinically relevant pelvic dysfunction were assessed [median PDCS 45.2 (IQR 33.3–60.6)]. Patients with a PDCS value of 0 were excluded from the validation analyses. There were no significant differences between treatment groups. PDCS correlated very well with PFDI-20, and moderately with the Wexner domain and manometric findings. The PDCS was significantly correlated with pain burden and sexual function.\nConclusions\nThe PDCS is a preliminary, multidimensional composite index that integrates symptom burden and anorectal functional findings in women with endometriosis. In the clinical setting, the proposed severity categories should therefore be regarded as exploratory and require validation in larger prospective cohorts before translating the results into practice.\nSimilar content being viewed by others\nIntroduction\nEndometriosis is defined as the presence of endometrial-like tissue outside the uterus, typically accompanied by a chronic, estrogen-dependent inflammatory process [1]. The prevalence of endometriosis among women of reproductive age is estimated at around 10% worldwide [2]. However, the real prevalence of endometriosis is not certain due to the high percentage of undiagnosed cases [3]. Moreover, prevalence varies by population: the highest is observed among women aged 25–29 years [4]. Among patients with chronic pelvic pain, the estimated prevalence is up to 28%, while it is up to 25% in women with infertility [5, 6].\nIn the broad symptomatologic spectrum of endometriosis, there are often pelvic floor symptoms such as urinary symptoms (dysuria, filling but also voiding symptoms), bowel symptoms (constipation, diarrhea, dyschezia), or sexual symptoms (anorgasmia, deep dyspareunia, arousal disorders) and impaired pelvic floor muscle function (increased muscle tone, low endurance, difficulty with relaxation) [6, 7]. At least 50–75% of patients with endometriosis have one or more pelvic floor symptoms with a wide spectrum of presentation that can differ in each patient [6]. Prevalence may vary across pelvic floor symptoms: In a multicenter cohort study, 56.4% of patients reported dyspareunia, 39.9% dyschezia, and 19.6% dysuria [8]. Other studies found increased pelvic floor muscle tone in up to 75% of women with endometriosis, and impaired relaxation or low muscle endurance in 50% [9]. Patients with endometriosis can also experience lower urinary tract symptoms (LUTS) such as urgency, frequency, incomplete bladder emptying, and bladder pain, with a prevalence rate that ranges from 8 to 33% [10]. Many studies have shown how pelvic dysfunction can have a great impact on the quality of life of patients with endometriosis, especially in young patients, so it is mandatory to screen, identify, and treat these symptoms properly [11, 12]. Many scales are available to screen for these symptoms.\nThe Pelvic Floor Distress Inventory – 20 PFDI-20, which is composed of three main domains [Urinary Distress Inventory–6 (UDI-6); Colorectal-Anal Distress Inventory-8 (CRADI-8), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6)] to screen for overall pelvic dysfunctions, is a tool recommended by the International Consultation on Incontinence for the assessment of pelvic floor dysfunction, and its role in the evaluation of women with endometriosis has been validated by many studies [13, 14].\nThe Female Sexual Function Index (FSFI) is a validated questionnaire for the screening of sexual dysfunctions by evaluating six domains (desire, arousal, lubrication, orgasm, pain, and satisfaction) [15]. A systematic review and meta-analysis assessed the effect of endometriosis on sexual function using the FSFI, which found significantly lower scores in all domains of the questionnaire in this population [16].\nThe Wexner constipation score is a tool to quantify the severity of constipation, including the frequency of bowel movements, difficulty, completeness of evacuation, and associated symptoms [17]. The Wexner Incontinence Scale is one of the most widely used and validated tools for assessing fecal incontinence severity [7, 18].\nThe Endometriosis Health Profile-30 (EHP-30) is one of the most validated instruments assessing endometriosis-related quality of life. It evaluates many aspects of quality of life, such as pain, emotional well-being, social support, and sexual function, and is strongly correlated with clinical evolution during treatment [19].\nThere are also diagnostic exams available to provide objective measurements of patient-reported symptoms, such as urodynamics for urinary storage and voiding dysfunction [20] and anorectal manometry for defecatory symptoms [21]. Although all these tools are validated instruments of diagnosis, none of these allow for a global evaluation of objective and subjective pelvic dysfunction; therefore, their use is limited to specific aspects of endometriosis-related symptoms and dysfunction. We aimed to build a composite score, the Pelvic Dysfunction Composite Score (PDCS), to evaluate pelvic floor dysfunction in patients who have endometriosis, combining scores of validated clinical scales (Wexner constipation and incontinence scales, PFDI- 20) and data from anorectal manometry (resting and squeeze pressure of anal sphincters; first sensation of rectal filling, rectoanal inhibitory reflex).\nMethods\nData Collection and Subdivision by Treatment\nThis study is a retrospective, single-center secondary analysis of data from patients with endometriosis treated surgically or medically (or both) at our institution (Division of Gynecology, Maternal and Child Department, Vanvitelli University Hospital, Naples, Italy) originally collected as part of an ethically approved prospective cohort study conducted in three centers: Division of Obstetrics and Gynecology, Maternal and Child Department, University Hospital of Pisa, Pisa, Italy; Division of Obstetrics and Gynecology Scientific Institute for Research, Hospitalization, and Healthcare (IRCCS) San Raffaele Hospital, Milan, Italy; and Division of Gynecology, Maternal and Child Department, Vanvitelli University Hospital, Naples, Italy. The study protocol was approved by the respective institutional review board of participating institutions (protocol 21086_SIMONCINI, approved on November 18, 2021). We analyzed data only for patients registered at our center for this study. Data collection included demographic variables, habits, obstetric and gynecological history, ultrasound parameters, urodynamic and anorectal manometry, and subjective scales (Wexner, PFDI-20, EHP-30, FSFI). Data were unified, cleaned, and verified for coherence. Patients were labeled as the “medical only” or “medical-surgical” group based on the treatment approach. Written informed consent for research use of data, including secondary analyses, had been obtained from all participants. We performed no additional procedures.\nPDCS Construction\nSub-scores Normalization\nThe Pelvic Dysfunction Composite Score (PDCS) was developed to derive a single composite index from three fundamental domains of pelvic dysfunction: subjective anorectal dysfunction (evaluated using Wexner scores for constipation and anal incontinence); overall pelvic floor symptoms (evaluated using the PFDI-20); and objective findings from anorectal manometry. Each domain was reported on a normalized scale from 0 to 100 to ensure comparability and to combine them into a single score.\nIncluded sub-scores (Wexner, PFDI-20, Manometry) were based on different ranges, so the scores were normalized and converted to a single scale with a score from 0 to 100:\n-\nWexner constipation + incontinence scales: maximum score = 50\n-\nPFDI-20: maximum score = 300\n-\nManometry: mean value of resting and squeeze pressure, the first rectal sensation, and the presence of rectoanal inhibitory reflex (RAIR) were considered. Values were inverted (lower pressure values indicate dysfunction) and normalized to a 0–100 scale.\n-\nWexner sub-score (0–100)\nTwo instruments measured subjective anorectal dysfunction:\n-\nWexner constipation score (range 0–30)\n-\nWexner continence score (range 0–20)\nThe sum of the two scores gives a global score, with an overall score of 50 that was then normalized on a 0–100 scale as follows:\nThis global score reflects the overall functional dysfunction of the anorectal district.\n-\nPFDI-20 sub-score (0–100)\nOverall pelvic dysfunction was measured by the Pelvic Floor Distress Inventory-Short Form 20 (PFDI-20), which includes:\n-\nPOPDI-6: prolapse symptoms (0–100)\n-\nCRADI-8: colorectal and anal symptoms (0–100)\n-\nUDI-6: urinary symptoms (0–100)\nThe summary score (0—300 range) was normalized with this formula:\nThe objective component of anorectal dysfunction was evaluated by anorectal manometry, considering four clinically relevant parameters (Table 1).\nThe manometry normalized score was calculated by assigning 25 points for each abnormal value, for a maximum of 100 points.\nCalculation of the Final PDCS Score\nPDCS was obtained as the arithmetic mean of the three normalized sub-scores.\nIf one of the three domains was missing, the score was calculated on the mean of the two available domains. Nevertheless, because none of the 29 patients included in this study had any missing data in each of the three domains (Wexner, PFDI-20, or manometry), the PDCS was derived from all three domains for all patients; consequently, a two-domain fallback was not used in the current cohort. Thus, scores from two domains (all combinations of the two domains) were not compared directly with scores from all three domains, since no actual score was available for a combined two-domain comparison.\nPDCS scores > 0 were subdivided into three groups as reported in Table 2.\nStatistical Analysis\nNormality Test\nThe distribution of PDCS and its sub-scores was evaluated by the Shapiro–Wilk test, chosen for its sensitivity in detecting deviations from normality in small sample sizes. Nonparametric tests for between-group comparisons were used because the data were non-Gaussian. The analysis revealed a non-Gaussian distribution of the variables considered; therefore, in accordance with the characteristics of the data, nonparametric statistical tests were adopted for comparisons between independent groups, specifically the Mann–Whitney U test.\nData were reported as medians with interquartile ranges (IQRs) because the sample did not follow a Gaussian distribution.\nInternal and Clinical Validation\nTwo complementary statistical procedures were used to conduct the internal validation of PDCS. To evaluate the latent structure of PDCS and to verify whether its three components describe the same clinical construct, an exploratory factor analysis was conducted using principal component analysis (PCA). Correlations between PDCS and its sub-scores were analyzed using the Spearman correlation coefficient, which measures the direction of the relationship between two ranked variables, ranging from −1 (perfect negative) to +1 (perfect positive), with 0 indicating no association.\nThe clinical validation of PDCS was obtained by the correlation analysis between severity categories and two relevant clinical outcomes: pelvic pain and sexual function. The outcomes were evaluated post-baseline by validated instruments:\n-\nPain domain of Endometriosis Health Profile-30 (EHP-30) for the evaluation of endometriosis-related pain\n-\nFemale Sexual Function Index (FSFI) for sexual function.\nResults\nAfter the exclusion of 12 patients with a PDCS score = 0 (no pelvic floor dysfunction), 29 patients with clinically relevant pelvic dysfunction were included in the analysis. Patients with PDCS = 0 were not included in the validation analysis because this study was directed toward characterizing severity patterns among women with clinically significant pelvic dysfunctions. This approach, however, does not evaluate the entire range of disease severity and should be kept in mind when interpreting the results.\nAmong the included patients, 15 were treated solely with medical therapy, while 14 underwent combined medical and surgical treatment (Table 3).\nPDCS Composition\nIn the analyzed cohort, PDCS showed a median of 45.2 [IQR 33.3–60.6; Range 10.3–92.2].\nThese values show a wide variability, with a median severity consistent with a moderate degree of pelvic dysfunction. The normalized scores of the three subscales and the total PDCS were compared between groups with the Mann–Whitney test, as reported in Table 4.\nNo statistically significant differences were found between groups in each domain. Therefore, the pelvic dysfunction severity was similar in patients who underwent medical treatment and in patients treated with a surgical and medical combined approach (Fig. 1).\nExploratory Assessment of Score Structure\nThe first component accounted for 68.8% of the total variance as determined by principal component analysis (PCA). Our findings indicate that the three domains, despite their differences, show high overlap in information about the global severity of pelvic dysfunction. The PCA is depicted in Fig. 2. Collectively, these findings indicate a high degree of shared information among the three domains, with the first component capturing the large majority of total variance. This pattern is consistent with a strong influence of the PFDI-20 on the composite score and does not, by itself, demonstrate independent or complementary contribution from each domain.\nExploratory Categorization of Pelvic Dysfunction Severity\nAn exploratory analysis of PDCS values suggested three categories of severity for pelvic dysfunction. Three severity categories were selected according to the exploratory analysis. Lower values across the PDCS domains identified the mild category; the moderate category showed intermediate impairment on symptom-based and objective measures. In the most severe category, higher scores across all domains were positively related to greater functional impairment. PDCS values were grouped into absent/mild (0–33), moderate (34–66), and severe (67–100) for descriptive purposes, as shown in Table 5. Severity categories were derived using an exploratory clustering method and used descriptively; thus, they should be interpreted as hypothesis-generative rather than as firm clinical thresholds.\nThe analysis of the correlation between PDCS and each score, evaluated by the Spearman coefficient (ρ), has shown that PDCS and PFDI-20 had ρ = 0.985, indicating a strong correlation, confirming the symptomatic component as one of the main drivers of the composite score; PDCS and Wexner score reported ρ = 0.549, indicating a moderate correlation; while PDCS and manometric parameters reported ρ = −0.600, indicating a moderate–severe inverse correlation due to the nature of manometry where by lower values indicate greater impairment and clinical severity.\nThe Spearman coefficient was also used to analyze the correlation between PDCS and clinical outcomes. A positive correlation was observed between PDCS and perceived pain (EHP-30 pain ρ = 0.383, p = 0.0403), indicating that higher PDCS scores are associated with greater referred pain. This relationship supports the clinical relevance of our score, indicating that the severity of pelvic floor dysfunction contributes to endometriosis-related pain. Relative to the FSFI total score, ρ = –0.544 (p = 0.0023). This statistically significant negative correlation indicates that higher PDCS values are associated with a worse overall sexual function. This can be explained by the relationship between impaired pelvic floor function and sexual dysfunctions such as dyspareunia, reduced desire, and discomfort during sexual activity (Fig. 3).\nThe clinical validation further suggests that PDCS consistently correlates with quality-of-life outcomes in patients with endometriosis. However, because PFDI-20 was the dominant contributor to the composite score, these associations cannot be specifically attributed to the inclusion of anorectal manometry or the other domains and should not be interpreted as establishing the added value of combining subjective and objective measures.\nDiscussion\nThe design of the PDCS aligns with a trend evident in the endometriosis literature in recent years, with an increased focus on developing composite or multidimensional clinical assessment tools [14, 22, 23]. Instruments such as the EHP-30 [19], the EFI [24], and the EPHect questionnaire [25, 26] reflect the need to incorporate multi-domain measures (pain, visceral function, psychological status, and impact on quality of life).\nThe PDCS appears to be a promising new instrument, showing good convergent validity in this preliminary sample. These findings suggest that the PDCS may offer a concise way to capture aspects of pelvic dysfunction complexity in affected women, although further validation in larger, prospective cohorts is needed before its clinical utility can be established. No statistically significant differences were observed between medical treatment and combined medical–surgical treatment, although this may reflect the limited sample size. The score nonetheless appeared to distinguish patients by symptom burden and subjective clinical severity, a finding that warrants confirmation in larger studies. Also, Mabrouk et al. observed a close interrelation between symptomatic and functional aspects. Their study on anorectal function in women with deep endometriosis also supports the clinical validity of integrating assessment [21].\nIn our study, the internal validation analysis showed that the first component explained 68.8% of the variance. This means that a single dimension can summarize a substantial proportion of the overall information contained across the three sub-scores. Although the three sub-scores represent different aspects of pelvic floor dysfunction (urinary symptoms, colorectal symptoms, and sphincter function), they are strongly convergent in describing a single clinical construct, which can be interpreted as the overall degree of pelvic dysfunction. An important observation was the strong correlation between PDCS and PFDI-20, indicating that symptom burden accounts for much of the composite score.\nOn the basis of this exploratory analysis, pelvic dysfunction in women with endometriosis was descriptively categorized into three severity groups. We caution against interpreting these categories too definitively, as they were based on exploratory analyses performed in a relatively small cohort and may need validation in independent populations. PDCS values were distributed, indicating discrete severity categories characterized by increasing levels of symptomatology and functional impairment. While these results support the potential utility of the PDCS for assessing varying degrees of pelvic dysfunction, they should not be considered definitive clinical phenotypes.\nThe mild severity category was defined by a low symptom score and preserved anorectal function, constructed largely of subjective symptoms and with a limited amount of objective functional impairment. An intermediate level of dysfunction was observed in the moderate category on both symptom-based and objective measures. Finally, the severe group was defined by significantly elevated Wexner and PFDI-20 scores in addition to a high incidence of manometric abnormalities indicative of significant pelvic floor dysfunction.\nThese severity classes should be interpreted as descriptive and hypothesis-generating, rather than definitive clinical categories. Because they were generated from a small dataset and have not been externally validated, their stability, reproducibility, and potential clinical utility remain unknown. It remains to be demonstrated whether these categories are reproducible with independent data and whether they predict distinct pathophysiological mechanisms or clinical outcomes.\nThese categories may help conceptualize the multifaceted burden of pelvic dysfunction, but prospective studies will be needed to determine their utility for treatment selection, prognostication, and interpretation of clinical data. Several limitations should be acknowledged. The small sample size substantially limits statistical power and generalizability. Second, this was a retrospective study at a single center and thus exposed to selection bias. Third, only patients with a PDCS value > 0 were included in validation analyses, as those with 0 were excluded from the validation cohort. Thus, it could not evaluate PDCS performance across the full range of pelvic floor dysfunction severity.\nA second major limitation concerns the development of our proposed severity categories. These categories, which were defined by exploratory clustering within the same dataset, should be regarded as hypothesis-generating rather than as firm clinical cutoffs. They will require independent validation in larger cohorts to evaluate stability and reproducibility.\nAnother key limitation is the extremely high correlation between PDCS and PFDI-20 (ρ = 0.985), indicating that this domain dominates the composite score. Because of the limited sample size, we were unable to perform sensitivity analyses, alternative weighting schemes, or domain-specific analyses to quantify the contribution of each component formally. Consequently, the added value of anorectal manometry, and of combining subjective and objective measures more generally, has not been established in this study and should not be inferred from the present findings. Future research should evaluate different weighting approaches and conduct sensitivity and domain-specific analyses to clarify the incremental utility of the objective functional assessment within PDCS.\nFinally, responsiveness to treatment over time, prognostic value, and clinical decision-making strategies were not assessed. Additionally, there was no external validation. Thus, PDCS should be perceived as a preliminary exploratory tool that needs further refinement and validation before its application in routine clinical practice.\nReferences\nPašalić E, Tambuwala MM, Hromić-Jahjefendić A. Endometriosis: classification, pathophysiology, and treatment options. Pathol Res Pract. 2023. https://doi.org/10.1016/j.prp.2023.154847\nZondervan KT, Becker CM, Missmer SA. 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Fertil Steril. 2014;102:1223–32. https://doi.org/10.1016/j.fertnstert.2014.07.1244\nFunding\nOpen access funding provided by Università degli Studi della Campania Luigi Vanvitelli within the CRUI-CARE Agreement.\nAuthor information\nAuthors and Affiliations\nContributions\nFM Caniglia: Manuscript writing, Data collection; C Casolari: Data analysis; F Giordano: Data collection; G Scalzone: Manuscript editing; M Torella: Project development; D Vinci: Manuscript writing; Data Analysis.\nCorresponding author\nEthics declarations\nEthical Approval\nThis is a retrospective secondary analysis of data collected from patients enrolled at our center (Division of Gynecology, Maternal and Child Department, Vanvitelli University Hospital, Naples, Italy) and included in a previously approved prospective cohort study conducted at three centers: Division of Obstetrics and Gynecology, Maternal and Child Department, University Hospital of Pisa (Pisa; Italy), Division of Obstetrics and Gynecology Scientific Institute for Research Hospitalization and Healthcare (IRCCS) San Raffaele Hospital (Milan; Italy), and Division of Gynecology, Maternal and Child Department, Vanvitelli University Hospital (Naples, Italy). The study protocol was reviewed and approved by the institutional review board of participating institutions (protocol 21086_SIMONCINI, approval date: 18 Nov 2021). Written informed consent for clinical, instrumental, and questionnaire data collection and analysis (including secondary analyses) was obtained from all participants. All data used in this analysis were from patients enrolled at our center only. No further treatment, investigational procedures, or contact was necessary. The study was performed in accordance with the Declaration of Helsinki principles.\nConflicts of interest\nNone.\nAdditional information\nHandling Editor: Rok Šumak\nEditor in Chief: Kaven Baessler\nPublisher’s Note\nSpringer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.\nRights and permissions\nOpen Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.\nAbout this article\nCite this article\nVinci, D., Caniglia, F.M., Casolari, C. et al. Development and Preliminary Evaluation of the Pelvic Dysfunction Composite Score (PDCS): A Pilot Study in Women with Endometriosis. Int Urogynecol J (2026). https://doi.org/10.1007/s00192-026-06877-0\nReceived:\nAccepted:\nPublished:\nVersion of record:\nDOI: https://doi.org/10.1007/s00192-026-06877-0","source_license":"public-domain-us","license_restricted":false}