Vaginal Pessaries for Pelvic Organ Prolapse or Stress Urinary Incontinence: A Health Technology Assessment.
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ABSTRACT:
SUBMITTER: Ontario Health (Quality)
PROVIDER: S-EPMC8129636 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
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Vaginal Pessaries for Pelvic Organ Prolapse or Stress Urinary Incontinence: A Health Technology Assessment.
Ontario health technology assessment series 20210506 3
<h4>Background</h4>Pelvic organ prolapse (POP) is the downward descent of the female pelvic organs into or through the vagina. The symptom that most strongly correlates with and is most specific for POP is a feeling of vaginal bulging. Stress urinary incontinence (SUI) is an involuntary loss of urine upon physical exertion or sneezing or coughing. Conservative (non-surgical) treatment options for both conditions include vaginal pessaries. We conducted a health technology assessment of vaginal pe ...[more]
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Project description:Two thirds of women opt to use a vaginal pessary initially to manage the symptoms of pelvic organ prolapse. In the UK most women attend a health care professional at least every six months to change the pessary. This represents a significant burden both economically to the health care system and personally for the woman. Annually there are more than 300 appointments for pessary changes at our hospital. We developed a programme to teach women to self-manage their pessaries with the aim of improving patient experience and reducing outpatient attendances to free up outpatient capacity for new referrals. A physiotherapist was recuited to deliver this programme involving a one to one training session supplemented with written materials and an online video. Women using pessaries were offered the option of self-management. Eighty-eight women aged between 29 to 84 years enrolled in the programme. Sixty-three women (73% of those enrolled) successfully continued with self-management at six months, creating 126 extra outpatient appointment capacity in one year alone. Women self-managing reported higher levels of convenience (94% vs 81%), accessibility (97% vs 73%), support (100% vs. 83%), and comfort (86% vs. 53%) than those attending the hospital for GP practice for pessary change. Self-management appears to be an acceptable option for many women using vaginal pessaries, with personal benefits to the women and economic benefits to the hospital and commissioners.
| S-EPMC4949618 | biostudies-literature
Project description:BackgroundLittle is known about short- and long-term pain and functional activity after surgery for pelvic organ prolapse.ObjectiveThe objectives of the study were to describe postoperative pain and functional activity after transvaginal native tissue reconstructive surgery with apical suspension and retropubic synthetic midurethral sling and to compare these outcomes between patients receiving 2 common transvaginal prolapse repairs, uterosacral ligament, and sacrospinous ligament vaginal vault suspension.Study designThis planned secondary analysis of a 2 × 2 factorial randomized trial included 374 women randomized to receive uterosacral (n = 188) or sacrospinous (n = 186) vaginal vault suspension to treat both stages 2-4 apical vaginal prolapse and stress urinary incontinence between 2008 and 2013 at 9 medical centers. Participants were also randomized to receive perioperative pelvic muscle therapy or usual care. All patients received transvaginal native tissue repairs and a midurethral sling. Participants completed the Surgical Pain Scales (0-10 numeric rating scales; higher scores = greater pain) and Activity Assessment Scale (0-100; higher score = higher activity) prior to surgery and at 2 weeks, 4-6 weeks, and 3 months postoperatively. The MOS 36-item Short-Form Health Survey was completed at baseline and 6, 12, and 24 months after surgery; the bodily pain, physical functioning, and role-physical subscales were used for this analysis (higher scores = less disability). Self-reported pain medication use was also collected.ResultsBefore surgery, average pain at rest and during normal activity were (adjusted mean ± SE) 2.24 ± 0.23 and 2.76 ± 0.25; both increased slightly from baseline at 2 weeks (+0.65, P = .004, and +0.74, P = .007, respectively) and then decreased below baseline at 3 months (-0.87 and -1.14, respectively, P < .001), with no differences between surgical groups. Pain during exercise/strenuous activity and worst pain decreased below baseline levels at 4-6 weeks (-1.26, P = .014, and -0.95, P = .002) and 3 months (-1.97 and -1.50, P < .001) without differences between surgical groups. Functional activity as measured by the Activity Assessment Scale improved from baseline at 4-6 weeks (+9.24, P < .001) and 3 months (+13.79, P < .001). The MOS 36-item Short-Form Health Survey Bodily Pain, Physical Functioning, and Role-Physical Scales demonstrated significant improvements from baseline at 6, 12, and 24 months (24 months: +5.62, +5.79, and +4.72, respectively, P < .001 for each) with no differences between groups. Use of narcotic pain medications was reported by 14.3% of participants prior to surgery and 53.7% at 2 and 26.1% at 4-6 weeks postoperatively; thereafter use was similar to baseline rates until 24 months when it decreased to 6.8%. Use of nonnarcotic pain medication was reported by 48.1% of participants prior to surgery, 68.7% at 2 weeks, and similar to baseline at 3 months; thereafter use dropped steadily to 26.6% at 2 years. Uterosacral ligament suspension resulted in less new or worsening buttock pain than sacrospinous suspension at 4-6 weeks postoperatively (4.6% vs 10.5%, P = .043) but no difference in groin or thigh pain.ConclusionPain and functional activity improve for up to 2 years after native tissue reconstructive surgery with uterosacral or sacrospinous vaginal vault suspension and midurethral sling for stages 2-4 pelvic organ prolapse. On average, immediate postoperative pain is low and improves to below baseline levels by 4-6 weeks.
| S-EPMC7250460 | biostudies-literature
Project description: Not available
| S-EPMC6513383 | biostudies-literature
Project description:ObjectiveTo evaluate the risk factors for postoperative urinary retention in women who underwent vaginal hysterectomy for symptomatic pelvic organ prolapse.MethodsThe medical records of 221 women who underwent vaginal hysterectomy with anterior and posterior colporrhapy were reviewed. Urinary retention after catheter removal was defined as the presence of at least one of the following three conditions: 1) failure of first voiding trial necessitating catheterization, 2) first residual urine volume after self-voiding ≥150 mL, and 3) Foley catheter re-insertion.ResultsUrinary retention occurred in 60 women (27.1%). Multivariate and receiver operating characteristic curve analysis revealed that age (>63 years) and early postoperative day of catheter removal (day 1) was independent predictor for postoperative urinary retention. The incidence of urinary retention was significantly higher in women who removed indwelling catheter at day 1 (35.2%) than those at day 2 (12.0%, P=0.024), or day 3 (21.3%, P=0.044), but was similar to those at day 4 (25.0%, P=0.420). In women ≤63 years, urinary retention rate was not associated with the time of catheter removal after surgery; however, in women >63 years, the rate was significantly higher in day 1 removal group than day 2 to 4 removal group.ConclusionAge and postoperative day of catheter removal appear to be associated with postoperative urinary retention in women undergoing vaginal hysterectomy for pelvic organ prolapse. Keeping urinary catheter in situ at least for one day after vaginal prolapse surgery could be recommended, especially, in women older than 63 years.
| S-EPMC4796084 | biostudies-literature
Project description:AimsTo evaluate the diagnostic ability of different cough stress tests (CSTs) in women with pelvic organ prolapse (POP), performed during outpatient urogynaecological exams.MethodsProspective, multicentre observational study involving women on waiting lists for POP surgery. With a subjectively full bladder, patients were asked to perform five different CSTs: without prolapse reduction ([a] standing, followed by [b] semilithotomy position); keeping semilithotomy position with prolapse reduced (by [c] posterior speculum, followed by [d] pessary); [e] standing again with the pessary in place. Primary outcome was positive CST in at least one of the five CSTs. Bladder volume was measured and symptoms of stress urinary incontinence (SUI) were detected by two validated questionnaires.ResultsA total of 297 women completed all CSTs and were included in the analyses. Mean (SD) age, parity, and body mass index were 64.8 (9.9) years, 2.7 (1.3) deliveries, and 26.6 (3.4) kg/m2 , respectively. In total, 99 women (33.3%) reported SUI symptoms. At least one positive CST was recorded in 152 patients (51.1%), and in 90 (59.2%) of these 152, a positive CST was observed only when POP was reduced (occult SUI). The CST was positive in 92 (92.9%) of the 99 patients with coexisting SUI symptoms and in 60 (30.3%) of the 205 asymptomatic patients. The percentage of patients with a positive CST was significantly lower when bladder volume was <200 mL vs ≥200 mL (P = .046).ConclusionsThe identification of urinary leakage cases with CSTs is best achieved using multiple different patient positions, different prolapse reduction methods, and bladder volumes ≥200 mL.
| S-EPMC7078860 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of pelvic floor muscle training (PFMT) on pelvic floor muscle (PFM) function and quality of life (QoL) in women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP).MethodsThis study will be a randomized, controlled, parallel, and blinded clinical trial. The final sample will consist of 32 women diagnosed with SUI and cystocele (stage I and II). All volunteers will be assessed and reassessed using the same protocol: assessment form, gynecological examination, functional evaluation of PFM, and questionnaires to assess quality of life, urinary function, and sexual function. All volunteers will be evaluated for satisfaction levels post-treatment. The intervention will be PFMT, totaling 16 sessions to be conducted twice a week. Reevaluation will take place at the end of treatment and 1 month after completion of PFMT. Descriptive analysis and repeated measures ANOVA will be used for result analysis. A significance level of p<0.05 will be considered for all statistical tests.Ethics and disseminationThis study has been submitted to the Ethics in Research Committee of the Federal University of Rio Grande do Norte and approved under protocol number 5.826.563. It has been registered with the Brazilian Clinical Trials Registry ReBec (RBR-49p6g3t). It is expected that these studies will provide a deeper understanding of the efficacy of PFMT in women with SUI and cystocele. Additionally, it aims to provide more insights into the efficacy of PFMT prior to surgery.
| S-EPMC11329135 | biostudies-literature
Project description:Introduction and hypothesisLimited data exist comparing different surgical approaches in women with advanced vaginal prolapse. This study compared 2-year surgical outcomes of uterosacral ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) in women with advanced prolapse (stage III-IV) and stress urinary incontinence.MethodsThis was a secondary analysis of a multicenter 2 × 2 factorial randomized trial comparing (1) ULS versus SSLF and (2) behavioral therapy with pelvic floor muscle training versus usual care. Of 374 subjects, 117/188 (62.7%) in the ULS and 113/186 (60.7%) in the SSLF group had advanced prolapse. Two-year surgical success was defined by the absence of (1) apical descent > 1/3 into the vaginal canal, (2) anterior/posterior wall descent beyond the hymen, (3) bothersome bulge symptoms, and (4) retreatment for prolapse. Secondary outcomes included individual success outcome components, symptom severity measured by the Pelvic Organ Prolapse Distress Inventory, and adverse events. Outcomes were also compared in women with advanced prolapse versus stage II prolapse.ResultsSuccess did not differ between groups (ULS: 58.2% [57/117] versus SSLF: 58.5% [55/113], aOR 1.0 [0.5-1.8]). No differences were detected in individual success components (p > 0.05 for all components). Prolapse symptom severity scores improved in both interventions with no intergroup differences (p = 0.82). Serious adverse events did not differ (ULS: 19.7% versus SSLF: 16.8%, aOR 1.2 [0.6-2.4]). Success was lower in women with advanced prolapse compared with stage II (58.3% versus 73.2%, aOR 0.5 [0.3-0.9]), with no retreatment in stage II.ConclusionsSurgical success, symptom severity, and overall serious adverse events did not differ between ULS and SSLF in women with advanced prolapse. ClinicalTrials.gov Identifier: NCT01166373.
| S-EPMC7483223 | biostudies-literature
Project description:BackgroundThere is an opioid epidemic in the United States with a contributing factor of opioids being prescribed for postoperative pain after surgery.ObjectiveAmong women who underwent stress urinary incontinence and pelvic organ prolapse surgeries, our primary objective was to determine the proportion of women who filled perioperative opioid prescriptions and to compare factors associated with these opioid prescriptions. We also sought to assess the risk of prolonged opioid use through 1 year after stress urinary incontinence and pelvic organ prolapse surgeries.Study designUsing a population-based cohort of commercially insured individuals in the 2005-2015 IBM MarketScan databases, we identified opioid-naive women ≥18 years who underwent stress urinary incontinence and/or pelvic organ prolapse procedures based on Current Procedural Terminology codes. We defined the perioperative period as the window beginning 30 days before surgery extending until 7 days after surgery. Any filled opioid prescription in this window was considered a perioperative prescription. For our primary outcome, we reported the proportion of opioid-naive women who filled a perioperative opioid prescription and reported the median quantity dispensed in the perioperative period. We also assessed demographic and perioperative factors associated with perioperative opioid prescription fills. Previous studies have defined prolonged use as the proportion of women who fill an opioid prescription between 90 and 180 days after surgery. We report this estimate as well as continuous opioid use, defined as the proportion of women with ongoing monthly opioid prescriptions filled through 1 year after stress urinary incontinence and/or pelvic organ prolapse surgery.ResultsAmong the 217,460 opioid-naive women who underwent urogynecologic surgery, 61,025 (28.1%) had pelvic organ prolapse and stress urinary incontinence surgeries, 85,575 (39.4%) had stress urinary incontinence surgery without pelvic organ prolapse surgery, and 70,860 (32.6%) had pelvic organ prolapse surgery without stress urinary incontinence surgery. Overall, 167,354 (77.0%) filled a perioperative opioid prescription, and the median quantity was 30 pills (interquartile range, 20-30). In a multivariate regression model, younger age, pelvic organ prolapse surgery with or without stress urinary incontinence surgery, abdominal route, hysterectomy, and mesh use remained significantly associated with opioid prescriptions filled. Among those with a filled perioperative opioid prescription, the risk of prolonged use defined as an opioid prescription filled between 90 and 180 days was 7.5% (95% confidence interval, 7.3-7.6). However, the risk of prolonged use defined as continuous use with at least 1 monthly opioid prescription filled after surgery was significantly lower: 1.2% (1.13-1.24), 0.32% (0.29-0.35), 0.06% (0.05-0.08), and 0.04% (0.02-0.05) at 60, 90, 180, and 360 days after surgery, respectively.ConclusionAmong privately insured, opioid-naive women undergoing stress urinary incontinence and/or pelvic organ prolapse surgery, 77% of women filled an opioid prescription with a median of 30 opioid pills prescribed. For prolonged use, 7.5% (95% confidence interval, 7.3-7.6) filled an opioid prescription within 90 to 180 days after surgery, but the rates of continuously filled opioid prescriptions were significantly lower at 0.06% (95% confidence interval, 0.05-0.08) at 180 days and 0.04% (95% confidence interval, 0.02-0.05) at 1 year after surgery.
| S-EPMC7704807 | biostudies-literature
Project description:BackgroundPelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common conditions affecting women's health and quality of life. In 50% of cases, SUI occurs after POP surgery, which is called de novo SUI. Predicting the risk of de novo SUI is a complex multi-attribute decision-making process. The current study made available a Decision Support System in the form of a fuzzy calculator web-based application to help surgeons predict the risk of de novo SUI.Materials and methodsWe first identified 12 risk factors and the diagnostic criteria for de novo SUI by means of a systematic review of the literature. Then based upon an expert panel, all risk factors were prioritized. A set of 232 fuzzy rules for the prediction of de novo SUI was determined. A fuzzy expert system was developed using MATLAB software and Mamdani Inference System. The risk prediction model was then evaluated using retrospective data extracted from 30 randomly selected medical records of female patients over the age of 50 without symptoms of urinary incontinence who had undergone POP surgery. Finally, the proposed results of the predictive system were compared with the results of retrospective medical record data review.ResultsThe results of this online calculator show that the accuracy of this risk prediction model, at more than 90%, compared favorably to other SUI risk prediction models.ConclusionsA fuzzy logic-based clinical Decision Support System in the form of an online calculator for calculating SUI prognosis after POP surgery in women can be helpful in predicting de novo SUI.
| S-EPMC8451324 | biostudies-literature
Project description:Introduction and hypothesisThe aim of the study was to translate into Polish the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), which evaluates sexual function in sexually active (SA) and not SA (NSA) women with pelvic floor disorders (PFD), and to validate the Polish version.MethodsAfter translation, back-translation and cognitive interviews, the final version of PISQ-IR was established. The study group included 252 women with PFD (124 NSA and 128 SA). All women underwent clinical evaluation and completed the PISQ-IR. For test-retest reliability, the questionnaire was administered to 99 patients twice at an interval of 2 weeks. The analysis of criterion validity required the subjects to complete self-reported measures. Internal consistency and criterion validity were assessed separately for NSA and SA women for the PISQ-IR subscales.ResultsThe mean age of the women was 60.9 ± 10.6 years and their mean BMI was 27.9 ± 4.9 kg/m2. Postmenopausal women constituted 82.5% of the study group. Urinary incontinence (UI) was diagnosed in 60 women (23.8%), pelvic organ prolapse (POP) in 90 (35.7%), and UI and POP in 102 (40.5%). Fecal incontinence was reported by 45 women (17.9%). The PISQ-IR Polish version proved to have good internal consistency in NSA women (α 0.651 to 0.857) and SA women (α 0.605 to 0.887), and strong reliability in all subscales (Pearson's coefficient 0.759-0.899; p < 0.001). Criterion validity confirmed moderate to strong correlations between PISQ-IR scores and self-reported measures in SA subscales, as well the SA summary score, and weak to moderate correlations in NSA women.ConclusionsThe PISQ-IR Polish version is a valid tool for evaluating sexual function in women with PFD.
| S-EPMC6761085 | biostudies-literature