Pelvic Organ Prolapse Quantification Research Articles

Predictor of Surgical Failure Following Transvaginal Mesh Repair Using Minimally Invasive Prolapse System Device (MIPS)

Background: The Minimally Invasive Prolapse System (MIPS) device, a novel single-incision transvaginal mesh, represents recent advancements in mesh technology, providing lightweight, biocompatible support for pelvic organ prolapse while reducing erosion, allowing for customization and improving surgical outcomes. This study aimed to identify factors associated with pelvic organ prolapse (POP) recurrence after transvaginal mesh (TVM) repair using the Minimally Invasive Prolapse System device. Methods: Two hundred and eighteen women with symptomatic stage II to IV POP underwent TVM. Preoperative and postoperative assessments included urinalyses and pelvic examinations using the POP quantification (POP-Q) staging system. Results: During a follow-up period of 12–46 months, 7 of 218 (3.2%) women experienced POP recurrence. Univariate analysis was conducted to identify predictors of surgical failure, revealing no significant differences in body mass index, POP stage, or preoperative urinary symptoms between the recurrence and success groups (p > 0.05). However, functional urethral length <20 mm based on urodynamics (p = 0.011), ICI-Q scores ≥7 (p = 0.012), and the first 60 surgical cases (p = 0.018) were significant predictors of surgical failure. Multivariate logistic regression confirmed these findings. Conclusions: Functional urethral length <20 mm, ICI-Q scores ≥7, and limited surgical experience were significant predictors of TVM failure using the Minimally Invasive Prolapse System kit. POP recurrence after mesh repair is less likely beyond the learning curve.

Transvaginal Mesh Versus Native Tissue Repair for Anterior and Apical Pelvic Organ Prolapse

ObjectivesThis prospective comparative cohort study aims to evaluate the safety and efficacy of transvaginal mesh compared to native tissue repair (NTR) in the surgical correction of anterior and apical compartment pelvic organ prolapse (POP) over a 36-month follow-up period. MethodsProspective comparative cohort study to prove superiority for efficacy and non-inferiority for serious adverse events (SAEs). The setting was 49 sites across the United States, Canada, Europe, and Australia. Women with bothersome POP symptoms indicated for vaginal surgery with pelvic organ prolapse quantification (POP-Q) scores of Ba ≥0 and C ≥ -1/2 TVL were included. Interventions included vaginal NTR or single-incision transvaginal mesh based on shared decision-making. POP recurrence, the primary efficacy endpoint, was defined as anatomical prolapse beyond the hymenal ring, subjective perception of protrusion or bulge, or retreatment in the target compartment. The primary safety endpoint consisted of the proportion of device and/or procedure-related SAEs in the target compartment. Secondary endpoints included surgical parameters, quality of life, postoperative pain, and sexual function. ResultsPOP recurrence rate at 12 months was 13.1% in the Mesh-arm and 11.5% in the NTR-arm (P = 0.44). The primary safety endpoint was met, with the Mesh-arm demonstrating statistically non-inferior outcomes compared to the NTR-arm in the incidence of device and/or procedure-related SAEs in the target compartment through 12 months (P < 0.01). At 36 months, the surgical POP recurrence rate was 26.7% in the Mesh-arm and 27.0% in the NTR-arm. ConclusionsAt 12- and 36-month follow-up, transvaginal mesh was not superior, but non-inferior in terms of efficacy and safety when compared to NTR for patients with combined anterior and apical compartment prolapse.

A novel suturing technique for natural tissue repair in cystocele treatment

BackgroundRecently, natural tissue repair has become popular in the treatment of pelvic organ prolapsed. In this study, we compared patients who underwent cystocele repair with the rug-weaving plication technique, a natural tissue repair method implemented since 2022 for anterior prolapse, with those treated using conventional colporrhaphy.MethodsWe retrospectively reviewed the data of 65 patients who underwent anterior vaginal wall repair with the rug-weaving plication technique (n = 33, Group 1) or conventional colporrhaphy (n = 32, Group 2). We recorded the patients’ clinicodemographic and surgical data. At the 6-month postoperative follow-up, we assessed patients’ complaints, degree of prolapse (using the simplified Pelvic Organ Prolapse Quantification system), and pelvic floor muscle strength (using the Modified Oxford Score). Anterior vaginal wall thickness was measured using transvaginal ultrasonography. We compared clinicodemographic and surgical data and postoperative outcomes between the two groups.ResultsThe two groups were comparable in terms of age (p = 0.326), number of pregnancies (p = 0.307), number of parities (p = 0.555), preoperative anterior wall simplified Pelvic Organ Prolapse Quantification grade (p = 0.380), preoperative apical prolapse simplified Pelvic Organ Prolapse Quantification grade (p = 0.518), postoperative Modified Oxford Score (p = 0.857), operation time (p = 0.809), postoperative haemoglobin (p = 0.674), and amount of bleeding (p = 0.951). Compared with Group 2, Group 1 had significantly higher postoperative anterior vaginal wall thickness (p < 0.001) and significantly lower postoperative anterior wall simplified Pelvic Organ Prolapse Quantification grade (p < 0.001).ConclusionsThe rug-weaving plication technique may offer a viable alternative for cystocele repair without mesh, using natural tissue and potentially reducing mesh-related complications and recurrence rates.Clinical trial numberNCT06410469 (03/05/2024).

Recurrent pelvic prolapse after pelvic organ prolapse suspension (POPS): Analysis and treatment of an emerging clinical issue

ObjectivesTo investigate pelvic organ prolapse (POP) after a novel abdominal prosthetic surgical technique – ‘pelvic organ prolapse suspension’ (POPS) – that has been proposed recently as an easily reproducible laparoscopic technique for the treatment of multicompartmental POP and rectal prolapse. This study also aimed to analyse treatment strategies of recurrent POP after POPS, reporting on anatomical, subjective and functional outcomes following recurrence surgery. MethodsPatients with a symptomatic prolapse relapse after POPS were collected and analysed prospectively at a single tertiary care institution. Each patient was offered a multidisciplinary clinical and radiological evaluation pre-operatively. ResultsTwenty-five women with a median age of 59 [interquartile range (IQR) 49–73] years were enrolled in the study. Of these, 88 % were menopausal. All patients had high-grade (Pelvic Organ Prolapse Quantification System stage > 2) recurrent posterior vaginal wall-predominant prolapse after POPS. Multicompartmental prolapse was found in 64 % of patients. All women complained of vaginal bulging associated with obstructed defaecation syndrome (ODS) symptoms. Surgical treatment consisted of laparoscopic ventral rectopexy (VR) in all 25 cases (100 %), and concomitant sacral colpopexy (SCP) with previous mesh removal in 16 cases (64 %). No anatomical recurrences were observed after median follow-up of 12 (IQR 3–18) months. Overall subjective improvement after surgery was high in all patients (Patient Global Improvement Index ≤ 2). ConclusionsRecurrent POP following POPS appears to predominantly involve the posterior vaginal wall, with associated ODS symptoms. A multidisciplinary approach is advisable for treatment of these patients. Minimally invasive VR alone or in combination with SCP seems to represent an effective treatment.

Diagnostic utility of translabial ultrasound in pelvic organ prolapse: a prospective observational study

Background The increasing awareness of women’s health issues, specifically pelvic organ prolapse (POP) and urinary incontinence (UI), has spurred a surge in patients seeking specialised advice for these conditions, necessitating modern diagnostic approaches for such issues. This study explored the diagnostic utility of translabial ultrasound for POP, emphasising its correlation with clinical assessments based on International Continence Society (ICS) criteria. Methods Seventy-one patients with POP Quantification System (POP-Q) stage 0-IV with or without UI were prospectively enrolled at Jagiellonian University Medical College between 2014 and 2016. The study objectives included evaluating diagnostic accuracy and concordance across pelvic compartments, correlating the diagnoses with patient-reported symptoms, and identifying variables contributing to diagnostic discrepancies. Results Translabial ultrasound identified POP in 74.5% of the patients, aligning closely with clinical evaluations. Concordance was the highest in assessments performed in the medial compartment (85.8%), while assessments performed in the anterior (29.6%) and posterior (29.6%) compartments showed higher rates of discrepancies. Correlation analyses showed varying associations, with the posterior compartment exhibiting the least pronounced correlation (R = 0.72, p < 0.0001). Self-perceive POP showed no discernible differences in relation to ultrasonographic and clinical assessments. Among the respondents, 55.9% reported experiencing the sensation of POP. Mean POP levels determined using the two approaches precisely matched in 46.5% of these cases. Discrepancies involved variables such as self-perceived POP, number of deliveries, child weight at birth, UI, and sexual activity. Conclusions Translabial ultrasound showed robust correlation with clinical assessments for evaluating POP, especially for defining defects and facilitating treatment-related decision-making. Our findings highlight the reliability of this method, particularly for assessments in the medial compartment. The evidence did not indicate the superiority of either method in detecting POP disorders for symptomatic versus asymptomatic patients. Significantly, a higher POP-Q measurement in clinical examination was correlated with greater sexual activity.

A Prediction Model for Pelvic Floor Recovery After Vaginal Birth With Risk Factors.

Although parturients report few postpartum symptoms, birth is clearly associated with future symptom development. The ability to identify asymptomatic at-risk women would facilitate prevention. The aim of the study was to develop a model predicting abnormal recovery in women at risk for childbirth-associated pelvic floor injury. Women undergoing first vaginal birth at high risk of pelvic floor injury underwent examinations and ultrasound imaging and completed 6-week and 6-month postpartum questionnaires. We defined "abnormal" recovery as having ≥1 of the following 3 findings: (1) levator ani injury, (2) decreased objective pelvic floor strength, and (3) Pelvic Organ Prolapse Quantification point Bp ≥0. Descriptive statistics and bivariate analyses compared "normal" and "abnormal" recovery. Birth characteristics, 6-week examinations, and questionnaires potentially predicted abnormal recovery at 6 months. Significant variables were included as candidates in the multivariable logistic regression predicting "abnormal" recovery after birth. Fifty-four women (63.5%) had normal and 31 (36.5%) had abnormal recovery at 6 months. At 6 weeks, women with abnormal recovery had decreased pelvic floor strength by Oxford scores (3 [2-5], 6 [2-8]; P = 0.002), lower point Bp (-1 [-3 to 0], -2 [-3 to -1]; P = 0.02), larger genital hiatus (4 [3 to 4], 3 [3 to 3.5]; P = 0.02), and higher levator ani injury rate (76.7%, 22.4%; P < 0.001). Between-group questionnaire differences were not clinically significant. Our final model included postpartum examination findings or birth characteristics: Oxford Scale, 6-week Pelvic Organ Prolapse Quantification GH strain, infant head circumference, and second stage ≥120 minutes. The area under the curve for predicting abnormal recovery at 6 months was 0.84, indicating a good sensitivity and specificity balance. The model identifies women at risk for an abnormal recovery trajectory.

Reliability and Validation of the PFIQ-7 and PFDI-20 in the Luganda Language

Introduction and HypothesisPelvic floor disorders (PFDs) impact women worldwide and are assessed using instruments such as the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7). There are no known valid PFD instruments in Uganda. This study’s purpose was to translate and test the reliability and validity of the PFDI-20 and PFIQ-7 in Luganda. It was predicted that these instruments would be reliable and valid to assess the presence and impact of PFD in parous Luganda-speaking women.MethodsThe translated PFDI-20 and PFIQ-7 were administered to parous Luganda-speaking women and readministered 4–8 months after. The Pelvic Organ Prolapse Quantification (POP-Q) examination determined the presence of pelvic organ prolapse (POP) and a cough-stress test (CST) measured urinary leakage. Analysis was completed using Cronbach’s α co-efficient for internal consistency and Spearman’s correlation coefficients and Wilcoxon rank sum tests for construct validity.ResultsOf the 159 participants, 93 (58.3%) had stage II POP or higher. The PFDI-20 and PFIQ-7 demonstrated minimal bother and impact on activities of daily living respectively. The Urinary Distress Inventory 6 (UDI-6) scores on the PFDI-20 showed a strong positive association with the presence of urinary incontinence. When PFD was defined by responses to symptom assessment, the translated PFDI-20 and PFIQ-7 could differentiate between individuals with and without PFD.ConclusionsThe UDI-6 section of the PFDI-20 was found to be valid in Luganda. The PFIQ-7 and the entirety of the PFDI-20 were not found to be reliable or valid, likely because of the low prevalence of PFDs in the study population.

Comparison of cervical length measured by pelvic organ prolapse quantification system and sonography

Comparison of cervical length measured by pelvic organ prolapse quantification system and sonography

Pelvic floor muscle training vs radiofrequency for women with vaginal laxity: randomized clinical trial.

Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30days; P = .049, 6 months; PFMT: P < .001, 30days and 6 months), with better results in the PFMT group. Sexual, vaginal, and urinary symptoms were improved after 30days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. After 30days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30days; however, this result was not maintained after 6 months of treatment.

Validation of the Lithuanian version of the Prolapse Quality-of-Life questionnaire.

We aimed to translate and validate the Lithuanian version of the Prolapse Quality-of-Life (P-QOL) questionnaire. The P-QOL questionnaire was translated into Lithuanian and administered to women recruited from a gynaecology outpatient clinic at a tertiary referral centre. The scores of the final version were compared in symptomatic (n = 137) and asymptomatic (n = 137) women and with findings on vaginal examination using the Pelvic Organ Prolapse Quantification system. The reliability was assessed by calculating Cronbach's alpha and by performing a test-retest analysis. There was a significant difference in median score for each P-QOL domain between symptomatic and asymptomatic women (p < 0.001). P-QOL scores correlated significantly with the stage of urogenital prolapse in most domains. High internal consistency was shown in all domains with a Cronbach's alpha range of0.775to0.958, except for the "social limitations" domain, which was shown to be acceptable (0.647). Test-retest reliability was also highin all domains (p < 0.05). The Lithuanian version of the P-QOL questionnaire has proven to be a valid, reliable and easily comprehensible instrument for assessing symptom severity and impact on the quality of life of Lithuanian-speaking women with urogenital prolapse.

Intraoperative Complications and Perioperative and Surgical Outcomes of Single-Port Robotics-Assisted Sacrocolpopexy.

The objective was to assess intraoperative and postoperative complication rates, along with perioperative and surgical outcomes, following single-port robotics-assisted sacrocolpopexy. This retrospective case series included 200 patients who underwent single-port robotics-assisted sacrocolpopexy to treat Pelvic Organ Prolapse Quantification (POPQ) stage 2-4 symptomatic prolapse between April 2020 and August 2023 by a single surgeon. Intraoperative and postoperative complications and perioperative outcomes were evaluated for all the patients, whereas surgical outcomes for 74 patients were assessed at 1-year follow-up. Surgical failure was defined as the presence of any of the following: the presence of vaginal bulging symptoms, any prolapse beyond the hymen, or retreatment for prolapse. During the study period, 200 single-port robotics-assisted sacrocolpopexies were performed. The median age and body mass index were 65.0 years and 24.6kg/m2 respectively. Most patients had POPQ stage 3 or 4 prolapse and underwent concomitant total hysterectomy. The median total operation time was 212.0min, and none of the patients required conversion to laparoscopy or laparotomy. The intraoperative cystotomy rate was 2.5%, and one patient had a blood transfusion owing to presacral vessel injury. Postoperative complications of mesh exposure and wound hernia were 0.5% and 2.0% respectively. At 1 year postoperatively, the rate of composite surgical failure was 9.5%, with a 5.4% anatomical recurrence rate. None of the patients experienced apical prolapse recurrence, and one received anterior colporrhaphy for anterior compartment prolapse recurrence. Single-port robotics-assisted sacrocolpopexy is safe and effective, with low complication rates and favorable perioperative and surgical outcomes.

Does pelvic floor morphometry change in women with pelvic organ prolapse after a short period of supine lying?

Introduction:Advice for women with pelvic organ prolapse (POP) often includes lying down to decrease the effects of gravity on the pelvic floor. The aim of this study was to compare pelvic floor morphometry before and after 30 min of supine lying in women with symptomatic POP. Methods:Pelvic floor morphometry was assessed in vaginally parous, premenopausal women with symptomatic POP ≥ stage 1. The modified Pelvic Organ Prolapse Quantification system was used in supine to assess points Ba (anterior vaginal wall), Bp (posterior vaginal wall), and C (cervix). Transperineal ultrasound imaging was used in supine and standing to assess the following measures at rest and bearing down: bladder neck position, bladder position, rectal ampulla position, levator plate angle, anorectal angle, levator anteroposterior distance, and levator hiatal area. Measures taken before and after 30 min of supine lying were compared. Results:Twenty-one women (median (range) age: 39 (29–50) years) with varied stages of POP (33% stage 1, 57% stage 2, and 10% stage 3) were included. Most measures of pelvic floor morphometry were unchanged after 30 min of supine lying compared to before lying. Participants had greater resting levator hiatal area in supine and levator anteroposterior distance at rest and bearing down in supine after lying down (p ≤ 0.001), suggesting reduced pelvic floor muscle activity. Conclusion:Findings suggest that a 30-min period of supine lying does not improve support of the pelvic organs.

The effect of stress incontinence and pelvic organ prolapse surgery on sexual function and quality of life.

The objective of this study was to evaluate the sexual function and quality of life in female patients diagnosed with stress urinary incontinence (SUI) and pelvic organ prolapse (POP) after undergoing transobturator tape (TOT) or TOT with POP surgery and perineoplasty. This prospective study population (n=86) consisted of sexually active women who had been diagnosed with SUI. Forty-six patients diagnosed with SUI with no POP (group 1) underwent TOT procedure only. Forty patients had a diagnosis of stage 2 and higher POP, based on POP quantification system with SUI (group 2). The second group was randomized as TOT-POP surgery (n=20) and TOT-POP surgery with perineoplasty (n=20). Prior to and six months after the surgical procedure, all female participants underwent assessment using the validated Urinary Distress Pre-Operative Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), and Pelvic Organ Prolapse Incontinence Sexual Questionnaire (PISQ). Post-operative IIQ-7 and UDI-6 scores were significantly lower for all three groups compared to the preoperative period, while a significant increase was observed in PISQ scores (p<0.01). The dissimilarity in preoperative and postoperative IIQ-7 and UDI-6 scores exhibited comparable results across the groups, whereas the variance in PISQ scores was notably greater in the TOT + POP surgery + perineoplasty group (p=0.03). Women with SUI or SUI with POP have better quality of life and sexual dysfunction after surgery. Perineoplasty may enhance sexual life in patients with perineal defect and vaginal enlargement.

POP-Q Versus Upright MRI Distance Measurements: A Prospective Study in Patients with POP

Introduction and HypothesisThe gold standard for quantifying pelvic organ prolapse is the pelvic organ prolapse quantification (POP-Q) system; however, upright magnetic resonance imaging (MRI) is a promising new method. The objective of this study was to determine the correlation between POP-Q and MRI measurements of the bladder and cervix.MethodsThis prospective study included patients with prolapse in whom POP-Q points Aa or Ba and C were measured as standard care. MRI scans were performed in an upright position, and the distances of the lowest points of the bladder and cervix to the Pelvic Inclination Correction System (PICS) were calculated. Correlations between POP-Q and MRI-PICS measurements were determined using the Pearson correlation coefficient for normally distributed data and the Spearman’s rank correlation coefficient for non-normally distributed data.ResultsA total of 63 patients were suitable for analysis. There was a moderate positive correlation between the POP-Q and MRI-PICS measurements for bladder (r(61) = 0.480, r < 0.001) and uterus (r(61) = 0.527, p < 0.001). Measurement differences between POP-Q and MRI-PICS of the bladder and uterus vary from −3.2 cm to 7.1 cm, and from −2.1 cm to 8.5 cm respectively. In 71.4% of patients more descent was seen on upright MRI than with POP-Q measurement for both bladder and uterus. For patients with similar POP-Q measurements, a high variation in MRI measurements of the bladder and uterus was found.ConclusionDespite a moderate positive correlation, upright MRI shows a larger POP extent in 71.4% of the patients than POP-Q. A high variation in MRI measurements for patients with the same POP-Q measurement was seen.

Three-year outcomes of a randomized clinical trial of perioperative vaginal estrogen as adjunct to native tissue vaginal apical prolapse repair

As the muscular and connective tissue components of the vagina are estrogen responsive, clinicians may recommend vaginal estrogen to optimize tissues preoperatively and as a possible means to reduce prolapse recurrence, but long-term effects of perioperative intravaginal estrogen on surgical prolapse management are uncertain. This study aimed to compare the efficacy of perioperative vaginal estrogen vs placebo cream in reducing composite surgical treatment failure 36 months after native tissue transvaginal prolapse repair. This was an extended follow-up of a randomized superiority trial conducted at 3 tertiary US sites. Postmenopausal patients with bothersome anterior or apical vaginal prolapse were randomized 1:1 to 1-g conjugated estrogen cream (0.625 mg/g) or placebo, inserted vaginally twice weekly for ≥5 weeks preoperatively and continued twice weekly for 12 months postoperatively. All participants underwent vaginal hysterectomy (if the uterus was present) and standardized uterosacral or sacrospinous ligament suspension at the surgeon's discretion. The primary report's outcome was time to failure by 12 months postoperatively, defined by a composite outcome of objective prolapse of the anterior or posterior walls beyond the hymen or the vaginal apex descending below one-third the total vaginal length, subjective bulge symptoms, and/or retreatment. After 12 months, participants could choose to use-or not use-vaginal estrogen for atrophy symptom bother. The secondary outcomes included Pelvic Organ Prolapse Quantification points, subjective prolapse symptom severity using the Patient Global Impression of Severity and the Patient Global Impression of Improvement, and prolapse-specific subscales of the 20-Item Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire-Short Form 7. Data were analyzed as intent to treat and "per protocol" (ie, ≥50% of expected cream use per medication diary). Of 206 postmenopausal patients, 199 were randomized, and 186 underwent surgery. Moreover, 164 postmenopausal patients (88.2%) provided 36-month data. The mean age was 65.0 years (standard deviation, 6.7). The characteristics were similar at baseline between the groups. Composite surgical failure rates were not significantly different between the estrogen group and the placebo group through 36 months, with model-estimated failure rates of 32.6% (95% confidence interval, 21.6%-42.0%) and 26.8% (95% confidence interval, 15.8%-36.3%), respectively (adjusted hazard ratio, 1.55; 95% confidence interval, 0.90-2.66; P=.11). The results were similar for the per-protocol analysis. Objective failures were more common than subjective failures, combined objective and subjective failures, or retreatment. Using the Patient Global Impression of Improvement, 75 of 80 estrogen participants (94%) and 72 of 76 placebo participants (95%) providing 36-month data reported that they were much or very much better 36 months after surgery (P>.99). These data included reports from 51 of 55 "surgical failures." Pelvic Organ Prolapse Quantification measurements, Patient Global Impression of Severity scores, and prolapse subscale scores of the 20-Item Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire-Short Form 7 all significantly improved for both the estrogen and placebo groups from baseline to 36 months postoperatively without differences between the groups. Of the 160 participants providing data on vaginal estrogen usage at 36 months postoperatively, 40 of 82 participants (49%) originally assigned to the estrogen group were using prescribed vaginal estrogen, and 47 of 78 participants (60%) assigned to the placebo group were using vaginal estrogen (P=.15). Adjunctive perioperative vaginal estrogen applied ≥5 weeks preoperatively and 12 months postoperatively did not improve surgical success rates 36 months after uterosacral or sacrospinous ligament suspension prolapse repair. Patient perception of improvement remained very high at 36 months.

Measuring Pelvic Organ Prolapse: An Evolution.

Advances in our understanding of pelvic organ prolapse (POP) have been made with the introduction of valid, reliable measures of anatomy and patient-reported outcome measures. This review provides an overview of the evolution of POP measurement and its implications for clinical practice and research. Since the introduction of the Pelvic Organ Prolapse Quantification (POPQ), studies have demonstrated that some degree of loss of anatomic support is normal, with as many as 40% of normal women having stage 2 prolapse. Vaginal support is dynamic and can wax and wane but is largely stable over time. Vaginal bulge symptoms are the most reliable and specific symptom for POP and the hymen is an important threshold for symptom development. Most pelvic floor symptoms have only weak to moderate correlation with the anatomic severity of POP. Treatment success rates are highly variable depending upon criteria used and definitions of anatomic success commonly used are too strict and often not clinically relevant. There is substantial discordance between subjective and anatomic measures of success, and both are dynamic, fluctuating between success and failure for many patients without intervening treatment. Pelvic organ prolapse is multidimensional, dynamic, and has a complex impact on patients. Patients' symptoms are more clinically relevant than anatomic support. Symptomatic cure, particularly the absence of vaginal bulge symptoms, is more clinically relevant than anatomic cure and composite outcomes can be misleading and overestimate failure rates. Future studies should compare treatments using continuous variables along multiple dimensions rather than using composite outcomes or dichotomizing patients into success or failure.

A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair

The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was280. Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval,-0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

A Randomised Trial on the Effects of the Addition of Uterosacral Ligament Plication to Pectopexy Operation on Anatomical Restoration and Female Sexual Functions.

The objective was to determine whether the addition of uterosacral ligament plication to pectopexy for pelvic organ prolapse increases anatomical improvement and female sexual functioning. This is a prospective randomised study. Forty patients who underwent laparoscopic pectopexy (LP) and laparoscopic pectopexy with uterosacral ligament plication (LPUSL) were included in the study. A total of 38 patients were evaluated in the study. Patients were assessed by the Pelvic Organ Prolapse Quantification (POP-Q) system and the patients who had symptomatic apical prolapse POP-Q ≥ II were included in the study. Patients were evaluated preoperatively and postoperatively at the 3rd, 6th and 12th month, with respect to anatomical changes as well as sexual function. A statistically significant difference was found when the preoperative C points was compared with the C points postoperatively, at 3rd, 6th and 12th months in both the LP and LPUSL groups (p < 0.001). Additionally, there were statistically significant difference between the LP and LPUSL groups in terms of C and Aa points at the 6th and 12th postoperative months in favour of the LPUSL group (p = 0.007, p = 0.005 respectively). There was also a statistically significant difference when Ba points were compared between the two groups at the 12th postoperative month, in favour of the LPUSL group (p = 0.002). There were no statistically significant differences between the groups with respect to the variables of the Female Sexual Function Index. Additionally, all parameters were significantly better in both groups at the 3rd and 12th months than the preoperative values in post hoc analysis; only desire also had a significant improvement between the 3rd and 12th months in the LPUSL group in post hoc analysis. Pectopexy operation seems to be a successful surgical approach as an alternative to sacrocolpopexy. The addition of uterosacral ligament plication to pectopexy operation improves the anatomical restoration more drastically than with LP on its own. Moreover, either LP or LPUSL has improved the majority of sexual function indices.

Effects of different treatment frequencies of electromagnetic stimulation for urinary incontinence in women: study protocol for a randomized controlled trial

BackgroundUrinary incontinence is highly prevalent in women while pelvic floor muscle training is recommended as the first-line therapy. However, the exact treatment regimen is poorly understood. Also, patients with pelvic floor muscle damage may have decreased muscle proprioception and cannot contract their muscles properly. Other conservative treatments including electromagnetic stimulation are suggested by several guidelines. Thus, the present study aims to compare the effectiveness of electromagnetic stimulation combined with pelvic floor muscle training as a conjunct treatment for urinary incontinence and different treatment frequencies will be investigated.Methods/designThis is a randomized, controlled clinical trial. We will include 165 patients with urinary incontinence from the outpatient center. Participants who meet the inclusion criteria will be randomly allocated to three groups: the pelvic floor muscle training group (active control group), the low-frequency electromagnetic stimulation group (group 1), and the high-frequency electromagnetic stimulation group (group 2). Both group 1 and group 2 will receive ten sessions of electromagnetic stimulation. Group 1 will be treated twice per week for 5 weeks while group 2 will receive 10 days of continuous treatment. The primary outcome is the change in International Consultation on Incontinence Questionnaire–Short Form cores after the ten sessions of the treatment, while the secondary outcomes include a 3-day bladder diary, pelvic floor muscle function, pelvic organ prolapse quantification, and quality of life assessed by SF-12. All the measurements will be assessed at baseline, after the intervention, and after 3 months of follow-up.DiscussionThe present trial is designed to investigate the effects of a conjunct physiotherapy program for urinary incontinence in women. We hypothesize that this strategy is more effective than pelvic floor muscle training alone, and high-frequency electromagnetic stimulation will be superior to the low-frequency magnetic stimulation group.

Comparison of the surgical outcomes between paravaginal repair and anterior colporrhaphy: A retrospective case–control study

ABSTRACT Objectives: This study compared the surgical outcomes of anterior vaginal wall repair (A-repair) and paravaginal repair (PVR) for laparoscopic pelvic organ prolapse (POP) surgeries. Materials and Methods: This retrospective case–control study recruited patients who underwent laparoscopic POP surgeries in our hospital from May 1, 2013, to May 31, 2022, using the health insurance surgical code payment system (laparoscopic colpopexy/hysteropexy/cervicopexy: 80025B) in Taiwan. The patients were divided into A-repair (group 1) and PVR (group 2). Patients aged &lt;20 years, without postoperative outcomes, and without baseline characteristics were excluded. Baseline characteristics (age, menopausal status, parity, diabetes mellitus, and hypertension) were collected. The outcome was to compare the changes in Pelvic Organ Prolapse Quantification (POP-Q) scores (Aa, Ba, and total vaginal length) preoperatively and 1–2 months, 3–6 months, and 1 year postoperatively in the two groups. Results: After exclusion, 23 and 10 patients in A-repair and PVR, respectively, were recruited. There was no significant difference in baseline characteristics between the two groups. Patients in both groups showed significant improvement in Aa and Ba of POP-Q 1–2 months and 3–6 months postoperatively, except for those in group 2 1 year postoperatively. However, there was no significant difference in postoperative scores between the two groups at 1–2 months, 3–6 months, and 1 year postoperatively. The estimated blood loss did not exhibit a significant difference between the two groups; however, PVR had a longer duration of operation. Conclusion: The surgical outcomes of A-repair and PVR for the anterior compartment were comparable at 1–2 months, 3–6 months, and 1 year postoperatively.