Conservative interventions for female exercise-induced urinary incontinence: a systematic review.

OBJECTIVE: To systematically review and synthesise what is known about the effectiveness of non-pharmaceutical conservative interventions for the management of urinary incontinence (UI) experienced by women during physical exercise. METHODS: A systematic search was performed in the following databases in September 2023: the Medical Literature Analysis and Retrieval System Online (MEDLINE), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Excerpta Medica dataBASE (EMBASE), Scientific Electronic Library Online (SciELO), Latin American and Caribbean Health Sciences Literature (LILACS), and Physiotherapy Evidence Database (PEDro). Studies were deemed eligible if population consisted of females who reported symptoms of UI while participating in physical exercise, and the interventions involved any non-pharmaceutical conservative treatment to manage symptoms during exercise. The primary outcome was severity of UI signs and symptoms. The protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO identifier: CRD42022379138). RESULTS: Of the 3429 abstracts screened, 19 studies were retained. Pelvic floor muscle training (PFMT) and intravaginal devices were the most commonly investigated modalities. Only two randomised controlled trials (RCTs), both among volleyball players, compared PFMT with no PFM exercise, showing a reduction in pad weight gain after the intervention in the experimental groups only. PFMT with and without biofeedback randomised among soldiers demonstrated a reduction in the frequency of urine leakage episodes in both groups, while supervised and unsupervised PFMT randomised among athletes from different sports showed pad weight gain reduction in the supervised group only. Seven single-arm studies suggested that PFMT alone or combined with other modalities may reduce UI severity in active women based on questionnaires, bladder diaries, and self-reported symptoms. A single-arm and a crossover study found pessary use beneficial in reducing urine leakage based on questionnaires and pad weight gain, respectively. When comparing pessary, tampon, and no intervention, two repeated-measures studies found tampons may reduce leakage more than pessaries in CrossFit exercisers and women performing aerobic exercises. A vaginal sponge also reduced pad weight gain during aerobic exercises. Other modalities (i.e., an intraurethral device, photobiomodulation, and combined therapies) were investigated using case series or single case studies. While all interventions showed some evidence of effectiveness, the results must be interpreted with caution due to methodological limitations and high risk of bias. In particular, despite a high reliance on pad tests as a primary outcome, we identified inconsistencies in how pad tests were administered and interpreted. CONCLUSION: Only the effectiveness of PFMT to reduce urine leakage during exercise has been evaluated through RCTs, with some evidence of effectiveness. We identified a clear need for higher quality studies, with better reporting on the interventions, and more judicious use and interpretation of outcome measures.

Clinical and cost-effectiveness of pessary self-management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation.

Background: Pelvic organ prolapse is common, causes unpleasant symptoms and negatively affects women's quality of life. In the UK, most women with pelvic organ prolapse attend clinics for pessary care. Objectives: To determine the clinical effectiveness and cost-effectiveness of vaginal pessary self-management on prolapse-specific quality of life for women with prolapse compared with clinic-based care; and to assess intervention acceptability and contextual influences on effectiveness, adherence and fidelity. Design: A multicentre, parallel-group, superiority randomised controlled trial with a mixed-methods process evaluation. Participants: Women attending UK NHS outpatient pessary services, aged ≥ 18 years, using a pessary of any type/material (except shelf, Gellhorn or Cube) for at least 2 weeks. Exclusions: women with limited manual dexterity, with cognitive deficit (prohibiting consent or self-management), pregnant or non-English-speaking. Intervention: The self-management intervention involved a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a local clinic telephone helpline number. Clinic-based care involved routine appointments determined by centres' usual practice. Allocation: Remote web-based application; minimisation was by age, pessary user type and centre. Blinding: Participants, those delivering the intervention and researchers were not blinded to group allocation. Outcomes: The patient-reported primary outcome (measured using the Pelvic Floor Impact Questionnaire-7) was prolapse-specific quality of life, and the cost-effectiveness outcome was incremental cost per quality-adjusted life-year (a specifically developed health Resource Use Questionnaire was used) at 18 months post randomisation. Secondary outcome measures included self-efficacy and complications. Process evaluation data were collected by interview, audio-recording and checklist. Analysis was by intention to treat. Results: Three hundred and forty women were randomised (self-management, n = 169; clinic-based care, n = 171). At 18 months post randomisation, 291 questionnaires with valid primary outcome data were available (self-management, n = 139; clinic-based care, n = 152). Baseline economic analysis was based on 264 participants (self-management, n = 125; clinic-based care, n = 139) with valid quality of life and resource use data. Self-management was an acceptable intervention. There was no group difference in prolapse-specific quality of life at 18 months (adjusted mean difference -0.03, 95% confidence interval -9.32 to 9.25). There was fidelity to intervention delivery. Self-management was cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year gained, with an estimated incremental net benefit of £564.32 and an 80.81% probability of cost-effectiveness. At 18 months, more pessary complications were reported in the clinic-based care group (adjusted mean difference 3.83, 95% confidence interval 0.81 to 6.86). There was no group difference in general self-efficacy, but self-managing women were more confident in pessary self-management activities. In both groups, contextual factors impacted on adherence and effectiveness. There were no reported serious unexpected serious adverse reactions. There were 32 serious adverse events (self-management, n = 17; clinic-based care, n = 14), all unrelated to the intervention. Skew in the baseline data for the Pelvic Floor Impact Questionnaire-7, the influence of the global COVID-19 pandemic, the potential effects of crossover and the lack of ethnic diversity in the recruited sample were possible limitations. Conclusions: Self-management was acceptable and cost-effective, led to fewer complications and did not improve or worsen quality of life for women with prolapse compared with clinic-based care. Future research is needed to develop a quality-of-life measure that is sensitive to the changes women desire from treatment. Study registration: This study is registered as ISRCTN62510577. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/82/01) and is published in full in Health Technology Assessment; Vol. 28, No. 23. See the NIHR Funding and Awards website for further award information.

Pelvic organ prolapse is a common and distressing condition experienced by large numbers of women. Prolapse is when the organs that are usually in the pelvis drop down into the vagina. Women experience a feeling of something coming down into the vagina, along with bowel, bladder and sexual problems. One possible treatment is a vaginal pessary. The pessary is a device that is inserted into the vagina and holds the pelvic organs back in their usual place. Women who use a vaginal pessary usually come back to clinic every 6 months to have their pessary removed and replaced; this is called clinic-based care. However, it is possible for a woman to look after the pessary herself; this is called self-management. This study compared self-management with clinic-based care. Three hundred and forty women with prolapse took part; 171 received clinic-based care and 169 undertook self-management. Each woman had an equal chance of being in either group. Women in the self-management group received a 30-minute teaching appointment, an information leaflet, a 2-week follow-up telephone call and a telephone number for their local centre. Women in the clinic-based care group returned to clinic as advised by the treating healthcare professional. Self-management was found to be acceptable. Women self-managed their pessary in ways that suited their lifestyle. After 18 months, there was no difference between the groups in women's quality of life. Women in the self-management group experienced fewer pessary complications than women who received clinic-based care. Self-management costs less to deliver than clinic-based care. In summary, self-management did not improve women's quality of life more than clinic-based care, but it did lead to women experiencing fewer complications and cost less to deliver in the NHS. The findings support self-management as a treatment pathway for women using a pessary for prolapse.

Development of progesterone electrospun nanofibers to coat Arabin pessaries as a dual preventive and therapeutic approach for preterm labor.

Preterm labor is a growing health problem that causes newborn death, and safe and effective therapy is significantly needed. Arabin pessaries and progesterone are preventive and therapeutic approaches that can be applied to managing the short cervix; hence, reducing the risk of preterm labor. The main goal of current work is to fabricate a novel nanofiber formulation based on polycaprolactone (PCL) and loaded with progesterone to coat for Arabin pessaries to be used as dual preventive and therapeutic approaches for local vaginal delivery. Several important criteria were considered in this study to assess the prepared nanofibers (i.e.; nanofiber diameter, progesterone loading efficiency, progesterone release profiles and in vitro cytotoxicity assessment). The results showed a dimeter of 397 ± 88 nm, drug loading of 142 ± 3 µg/mg and encapsulation efficiency of 99 ± 2 % for the progesterone-loaded nanofibers. Approximately, 17 % of progesterone was released from the nanofibers after 90 days. The in vitro assessment showed that the application of progesterone is safe upon 24 and 48-hours incubation on HFF-1 cell line at concentrations ≤ 32 µg/mL and within 72-hours at a dose of ≤ 8 µg/mL. To conclude, the data recommended that progesterone-loaded nanofibers can coat the Arabin pessaries with the potential of being a safe and effective dual preventive and therapeutic tool for preterm labor.

Patient experience of pain during vaginal pessary removal and insertion: a service evaluation study.

INTRODUCTION AND HYPOTHESIS: Pelvic organ prolapse is a common problem affecting women, but there is currently a lack of research focusing on patient experience of pessary changes. This study was aimed at capturing the patient perspective of pessary changes and formally assessing pain during pessary removal and insertion. METHODS: A service evaluation request was granted by South Tees Hospitals NHS Trust. Patients undergoing pessary change (ring, shelf, or Gellhorn) in gynaecology outpatient clinics over a 6-month period were asked to rate their pain scores on a ten-point numerical pain-rating scale. Other associated data were collected. RESULTS: Out of 213 women, 58.2% reported that pessary removal was more painful than insertion, 30.5% reported equal pain, and 10.8% reported that insertion was more painful than removal. Pain scores were significantly higher for removal (mean 4.37, median 4, IQR 4-7) than for insertion (mean 2.66, median 2, IQR 2-4, p <0.001). Ring pessaries were significantly less painful to both remove and insert than shelf and Gellhorn pessaries. Smaller pessaries were more painful to both remove and insert. There was no significant difference in pain scores reported by those with or without diagnosed vulval conditions. CONCLUSIONS: Pessary removal causes most women moderate pain, which should be communicated to patients beforehand. Ring pessaries are significantly less painful to change than other pessary types. Clinicians should consider pain as a factor in their decision-making surrounding pessary choice and when counselling patients. Future research should focus on ways to reduce pain during pessary removal.

Vaginal microflora following the use of a disposable home-use vaginal device and a commercially available ring pessary for pelvic organ prolapse management: a randomized controlled trial.

PURPOSE: To investigate whether ProVate, a novel, disposable, self-inserted vaginal device for pelvic organ prolapse management, clinically affects the vaginal microflora, as compared with a commercially available ring pessary, to assess its microbiological safety. METHODS: This interventional, prospective, multi-center, open-label, randomized, controlled, statistically powered (noninferiority), home-use, crossover study was conducted at seven sites. Participants were randomized into either group A (using ProVate and then a new reusable commercially available ring pessary [control]) or B (using control device and then ProVate) with a 1:1 ratio. Noninferiority of ProVate over the control was evaluated for the primary endpoint, which was based on meeting one of the failure criteria: significant change in Lactobacillus spp., Gardnerella vaginalis, Candida morphotypes, or Staphylococcus aureus levels compared to the baseline (significant change: Nugent score ≥ 7 or > 1 scale unit increase in S. aureus or Candida morphotype), bothersome vaginal infection symptoms, or symptoms requiring treatment for infection. RESULTS: The study included 58 participants (mean age: 64.5 years, 91.4% postmenopausal). There were no significant microfloral changes in terms of the four microorganisms mentioned above, the rate of Nugent score ≥ 7 after use was low and comparable between the two devices, and the rate of patients with a > 1 unit-scale change (increase or decrease) from the baseline to the end-of-use phase in any studied microorganism was comparable between the devices. The failure rate was 15.5% for ProVate and 15.5% for control while using 383 ProVate devices over 1647 days or one control device throughout the study. Two patients had bothersome vaginal complaints and one had overt vaginal infection in the control group, but no such cases were observed in the ProVate group. CONCLUSION: The primary endpoint of possible vaginal microbial changes, bothersome vaginal symptoms, or treatment-requiring vaginal complaints while using ProVate was successfully met. Our findings show that the vaginal microflora is comparable when using either ProVate or commercially available ring pessary (control) with a relatively low rate of vaginal infections. Trial registration details: ClinicalTrials.gov; URL: https://www. CLINICALTRIALS: gov/ct2/show/NCT03345121?term=NCT03345121&draw=2&rank=1 ; No. NCT03345121; Registration date, November 17, 2017; initial enrollment started on August 20, 2017.

Pre-exposure prophylactic mucoadhesive sodium alginate microsphere laden pessaries for intravaginal delivery of tenofovir disoproxil fumarate.

The research aimed to develop novel bioadhesive sodium alginate (Na-Alg) microspheres laden pessaries for intravaginal delivery of tenofovir disoproxil fumarate (TDF), to overcome limitations of conventional dosage forms. Twelve batches of microspheres formulated by emulsification gelation method indicated that drug-polymer ratios and polymer type affected particle size, drug release, and entrapment efficiency (%EE). Microspheres of batch EH-8 with drug: polymer ratio of 1:4 containing equal amounts of Na-Alg and HPMC K100M displayed optimal %EE (62.09 ± 1.34 %) and controlled drug release (97.02 ± 4.54 % in 12 h). Particle size analysis in Matersizer indicated that microspheres (EH-8) displayed a surface-mean diameter of 11.06 ± 0.18 µm. Ex-vivo mucoadhesion studies on rabbit mucosa indicated that microspheres (EH-8) adhered well for 12 h. Microspheres integrated into pessaries displayed a sustained release profile (95.31 ± 1.37 % in 12 h) in simulated vaginal fluid. In vivo studies in rabbits indicated that pessaries displayed a significantly higher Cmax (41.18 ± 3.57 ng/mL) (P < 0.005) and reduced Tmax (1.00 ± 0.01 h) (P < 0.0001) of TDF concentrations in vaginal fluid compared to oral tablets. The microparticulate pessaries with the ability to elicit higher vaginal fluid levels in the crucial initial hours of insertion demonstrates a potential novel platform to offer better self-protection to HIV-negative women against HIV during sexual intercourse.

A randomized controlled study comparing the objective efficacy and safety of a novel self-inserted disposable vaginal prolapse device and existing ring pessaries.

Introduction: ProVate is a novel, disposable, collapsible self-inserted vaginal device for the nonsurgical management of pelvic organ prolapse (POP). We assessed possible vaginal microflora changes and POP reduction using ProVate and a commercially available ring pessary (control). Methods: We performed post-hoc analysis of data obtained from an interventional, prospective, multicenter, open-label, randomized, controlled, statistically powered (noninferiority), home-use, cross-over study conducted at seven sites. Safety and performance data collected for both devices were analyzed to compare objective POP reduction (employing the Pelvic Organ Prolapse Quantification System [POP-Q]), safety (assessed by the incidence of adverse events [AEs]), and the rates of certain AEs. Results: Eighty-five women with symptomatic POP were screened; 71 were randomized, and 58 completed the study per protocol. Forty-nine (90.7%) ProVate users experienced complete prolapse reduction (stage 0), 3 (5.6%) experienced reductions to POP-Q stage 1, and 2 (3.7%%) experienced reductions to stage 2. Collectively, 52/54 (96.3%) ProVate users experienced prolapse reduction to stage 0 or 1. In all, 47/57 (82.5%) control users experienced complete prolapse reduction, while 5 (8.8%), 4 (7.0%), and 1 (1.8%) experienced reductions to stage 1, 2, and stage 3, respectively. Collectively, 52/57 (91.2%) control users experienced reductions to either stage 0 or 1. In 53/54 (98.1%) ProVate and 55/57 (96.5%) control users, there was at least 1 POP-Q stage prolapse reduction, and in 32 (91.4%) ProVate and 31 (83.8%) control users who had stage ≥3 prolapse, there were at least three POP-Q stage reductions. In total, 26/71 (36.6%) ProVate and 22/64 (34.4%) control users in the safety population experienced AEs. The incidence of device-related AEs was 17/71 (23.9%) for ProVate and 13/64 (20.3%) for the control. Most AEs were minor, mild, and anticipated. Conclusion: Our analysis demonstrated that ProVate and the control are highly effective in reducing POP, and both are associated with comparably low numbers of AEs. However, ProVate has the advantage of being more user-friendly, suitable for home use, and expected to allow women with POP to practice better and easier self-care.

Menstrual tampons and vaginal pessaries: regulation of intravaginal medical devices by the US FDA.

Catamenial products like menstrual tampons for managing menses and vaginal pessaries for managing urinary incontinence and uterine prolapse are products that can be inserted and removed from the vagina repeatedly over a woman's lifetime. In the United States (US), these products are considered to be medical devices and are regulated by the Center for Devices & Radiological Health (CDRH) of the Food and Drug Administration (FDA). As such, they are subject to both premarket and postmarket regulatory controls. Both tampons and pessaries have a long history of safe and effective use, and FDA applies a risk-based approach to both premarket entry as well as continued postmarket regulatory controls. Practicing clinicians are often the initial source of ideas for medical device improvements. This article is intended to help such clinicians to understand the regulatory challenges faced by development teams who seek to introduce these kinds of products to the US market. It explains FDA's risk-based classification of medical devices and the 510(k) premarket notification as the primary regulatory mechanism for market entry. It also highlights key FDA guidance documents and encourages early engagement with FDA when appropriate.

A Novel Incisionless Disposable Vaginal Device for Female Stress Urinary Incontinence: Efficacy and Quality of Life.

PURPOSE: This clinical study sought to evaluate the possible clinical effectiveness and practicality of URINO, an innovative, incisionless, and disposable intravaginal device, designed for patients suffering from stress urinary incontinence. METHODS: A prospective, multicenter, single-arm clinical trial was carried out, involving women diagnosed with stress urinary incontinence who used a self-inserted, disposable intravaginal pessary device. Comparisons were made between the results of the 20-minute pad-weight gain (PWG) test at baseline and visit 3, where the device was applied. After 1 week of device usage, compliance, satisfaction, the sensation of a foreign body, and adverse events were assessed. RESULTS: Out of 45 participants, 39 completed the trial and expressed satisfaction within the modified intention-to-treat group. The average 20-minute PWG of participants was 17.2±33.6 g at baseline and significantly dropped to 5.3±16.2 g at visit 3 with device application. A total of 87.2% of participants exhibited a reduction ratio of PWG by 50% or more, surpassing the clinical trial success benchmark of 76%. The mean compliance was recorded as 76.6%±26.6%, the average visual analogue scale score for patient satisfaction was 6.4±2.6, and the sensation of a foreign body, measured on a 5-point Likert scale, was 3.1±1.2 after 1 week of device use. No serious adverse events were reported; there was 1 instance of microscopic hematuria and 2 cases of pyuria, all of which recovered. CONCLUSION: The investigated device demonstrated significant clinical effectiveness and safety for patients with stress urinary incontinence. It was easy to use, showing favorable patient compliance. We propose that these disposable intravaginal pessaries could potentially be an alternative treatment for patients with stress urinary incontinence who are seeking nonsurgical options or are unable to undergo surgery. Trial Registration: The study was registered as a clinical trial (KCT0008369).

The impact on complication rates of delayed routine pessary reviews during the COVID-19 pandemic.

INTRODUCTION AND HYPOTHESIS: During the COVID-19 pandemic, guidance was issued in the United Kingdom advising a delay in routine pessary reviews. The impact of this has not been fully explored. The null hypothesis for this study is that delayed routine pessary reviews during the COVID-19 pandemic did not result in a statistically significant increase in complication rate. METHODS: A retrospective comparative cohort study was conducted in NHS Tayside, Scotland, involving 150 patients pre-pandemic and 150 patients during the COVID-19 pandemic (before exclusions). Their notes were reviewed identifying age, care provider, pessary type, length of pessary usage, review date, time elapsed since the previous review, bleeding/infection/ulceration, removal issues, pessary replacement and outcome. Patients excluded were those with no pessary in situ at review, reviews at ≤4 months and >8 months (pre-pandemic) and reviews at ≤8 months (COVID-19 pandemic). RESULTS: The pre-pandemic group (n=106) had average review times of 10.1,6.2 and 6.2 months for cubes, rings and all others. Overall rates of bleeding/infection/ulceration; reported removal issues; and pessary subsequently not replaced were 9.4%, 11.3% and 5.7% respectively. The COVID-19 pandemic group (n=125) had average review times of 14.7, 10.8 and 11.4 months for cubes, rings and all others. Overall rates of bleeding/infection/ulceration; reported removal issues; and pessary subsequently not replaced were 21.6%, 16.0%, and 12.0% respectively. CONCLUSIONS: Overall, there was a significant increase in rates of bleeding/ulceration/infection (p=0.01). When individual pessaries were considered, this only remained true for rings (p=0.02). Our data would suggest that routine ring pessary reviews should not be extended beyond 6 months or risk bleeding/ulceration/infection.

Ratio of Women with POP Using Pessary, Improvement in Urination and Quality of Life.

INTRODUCTION: Pelvic organ prolapse (POP) has a general incidence of > 10% in the female population of the Western world. The pessary is a silicone device, it is inserted into the vagina to provide support to the pelvic organs. It is used as a conservative treatment to improve prolapse symptoms. OBJECTIVE: To evaluate urination among women with a pessary and women without a pessary and to evaluate the effectiveness of pessary treatment in pelvic organ prolapse with voiding difficulties. MATERIAL AND METHODS: A prospective and quasi-experimental observational study of an analytical nature was conducted. It will consist of analyzing the results of treatment with vaginal pessaries in women with POP. A total of 60 women were chosen as a sample of the study, 50% were placed with the pessary. PGI test and uroflujometry were used. RESULTS: The placement of pessary shows how there is a significant correlation between the quality of life of women and urination. CONCLUSIONS: There is a relationship between the improvement of the quality of life and the improvement of the mycological dynamics of women in pessary treatment. However, the improvement in the quality of life cannot be attributed solely to the improvement of urinary flow, but also to the well-being caused by the reduction of POP.

Ratio of Women with POP Using Pessary, Improvement in Urination and Quality of Life

Introduction: Pelvic organ prolapse (POP) has a general incidence of > 10% in the female population of the Western world. The pessary is a silicone device, it is inserted into the vagina to provide support to the pelvic organs. It is used as a conservative treatment to improve prolapse symptoms. Objective: To evaluate urination among women with a pessary and women without a pessary and to evaluate the effectiveness of pessary treatment in pelvic organ prolapse with voiding difficulties. Material and Methods: A prospective and quasi-experimental observational study of an analytical nature was conducted. It will consist of analyzing the results of treatment with vaginal pessaries in women with POP. A total of 60 women were chosen as a sample of the study, 50% were placed with the pessary. PGI test and uroflujometry were used. Results: The placement of pessary shows how there is a significant correlation between the quality of life of women and urination Conclusions: There is a relationship between the improvement of the quality of life and the improvement of the mycological dynamics of women in pessary treatment. However, the improvement in the quality of life cannot be attributed solely to the improvement of urinary flow, but also to the well-being caused by the reduction of POP (AU)

Introducción: El prolapso de órganos pélvicos (POP)presenta una incidencia general de > 10% en la poblaciónfemenina del mundo occidental. El pesario es un dispositivo de silicona, se introduce en la vagina para proveer soporte a los órganos pélvicos. Se utiliza como tratamientoconservador para mejorar los síntomas del prolapso.Objetivo: Evaluar las micciones entre las mujeres conpesario y las mujeres sin pesario y evaluar la efectividad deltratamiento del pesario en los prolapsos de órganos pélvicosque tienen dificultad miccionalMaterial y Métodos: Se llevó a cabo un estudioobservacional prospectivo y cuasi experimental, de carácter analítico. Consistirá en analizar los resultados detratamiento mediante pesarios vaginales en mujeres conPOP. Un total de 60 mujeres fueron elegidas como muestradel estudio, al 50% se les colocó el pesario. Se utilizó eltest PGI y la uroflujometría.Resultados: La colocación del pesario muestra comoexiste una correlación significativa entre la calidad de vidade las mujeres con POP y las micciones.Conclusiones: Existe relación entre la mejora de lacalidad de vida y la mejora de las dinámicas miccionalesde las mujeres en tratamiento con pesario. Sin embargo,la mejora de la calidad de vida no se puede atribuir únicamente a la mejora del flujo urinario, sino también al bienestar provocado por la reducción del POP (AU)

Magnetic resonance imaging evaluation of the effectiveness of FemiCushion in pelvic organ prolapse.

AIMS: FemiCushion (FC) is a supportive device for pelvic organ prolapse (POP), but its effectiveness has not been evaluated with imaging studies. This study utilized magnetic resonance imaging (MRI) to evaluate the anatomic changes induced by FC use in patients with severe POP. METHODS: This prospective study examined patients with stage 3 or 4 POP who underwent treatment with FC and received a diagnostic MRI. Measurements were made in the midsagittal plane at rest and during straining with and without FC. The vertical distances from the lowest points of the anterior and posterior vaginal wall (A; P), uterine cervix or vaginal stump (C), and perineal body (PB) to the Pelvic Inclination Correction System line were measured, along with the lengths of the urogenital (UGH) and levator hiatus (LH). RESULTS: Twelve patients were included in the study. The median age was 72 (range, 56-84) years. All reference points were positioned significantly higher with the FC than without the FC (median ΔA: 11 mm, p = 0.005; ΔC: 14 mm, p = 0.011; ΔP: 6 mm, p = 0.008; ΔPB: 7 mm, p = 0.002). Median UGH and LH lengths during straining were significantly shorter with the FC than without the FC (UGH: 44 mm vs. 53 mm, p = 0.002; LH: 60 vs. 65 mm, p = 0.021). CONCLUSIONS: This is the first report on the use of MRI to measure the performance of FC. Our study demonstrates that FC effectively repositioned the organs involved in POP.

Pessary fitting for pelvic organ prolapse: parameters associated with specific reasons for failure.

INTRODUCTION AND HYPOTHESIS: The objective was to assess if specific reasons for unsuccessful pessary fitting have different predictive parameters. METHODS: This is a prospective observational case-control study of women with symptomatic pelvic organ prolapse (POP) choosing pessary treatment. All women underwent an interview, clinical examination, and 3D/4D transperineal ultrasound (TPUS). Groups were defined based on fitting outcome: successful, pessary dislodgment, failure to relieve POP symptoms, pain/discomfort, increased/de novo urinary incontinence, or other reasons. Clinical, demographic, and TPUS parameters were assessed in the prediction of different reasons for unsuccessful fitting and receiver operating characteristic (ROC) curves were constructed. RESULTS: A total of 162 women were assessed and 130 were included. Levator hiatal area (HA) on maximum Valsalva divided by ring pessary size ("Valsalva HARP ratio") was a predictor of unsuccessful fitting (OR 3.00, 95% CI 1.15-7.81, p = 0.025) with an area under the ROC curve (AUC) of 0.62 (95% CI 0.50-0.74, p = 0.04). Predictors of pessary dislodgment were: complete avulsion (OR 24.20, 95% CI 2.46-237.84, p value 0.01) and Valsalva HARP ratio (OR 2.94, 95% CI 1.32-6.55, p value 0.01) with an area under the ROC curve (AUC) of 0.92 (95% CI 0.84-0.99, p = 0.00). No significant parameter was identified in the prediction of pain/discomfort. Solitary predominant posterior compartment POP was a predictor of failure to relieve POP symptoms (OR 20.00, 95% CI 3.48-115.02, p value 0.00; AUC 0.75, 95% CI 0.53-0.98, p = 0.03). CONCLUSION: Complete avulsion and a small ring pessary with respect to the levator HA in Valsalva are predictors of pessary dislodgment, whereas solitary predominant posterior compartment POP is a predictor of failure to relieve POP symptoms.

Parameters associated with unsuccessful pessary fitting for pelvic organ prolapse up to three months follow-up: a systematic review and meta-analysis.

OBJECTIVES: To clarify which parameters are associated with unsuccessful pessary fitting for pelvic organ prolapse (POP) at up to 3 months follow-up. METHODS: Embase, PubMed and Cochrane CENTRAL library were searched in May 2020. Inclusion criteria were: (1) pessary fitting attempted in women with symptomatic POP; (2) pessary fitting success among the study outcomes with a maximal follow-up of 3 months; (3) baseline parameters compared between successful and unsuccessful group. A meta-analysis was performed using the random effects model. MAIN RESULTS: Twenty-four studies were included in the meta-analysis. Parameters associated with unsuccessful pessary fitting were: age (OR 0.70, 95% CI 0.56-0.86); BMI (OR 1.35, 95% CI 1.08-1.70); menopause (OR 0.65 95% CI 0.47-0.88); de novo stress urinary incontinence (OR 5.59, 95% CI 2.24-13.99); prior surgery, i.e. hysterectomy (OR 1.88, 95% CI 1.48-2.40), POP surgery (OR 2.13, 95% CI 1.34-3.38), pelvic surgery (OR 1.81, 05% CI 1.01-3.26) and incontinence surgery (OR 1.87, 95% CI 1.08-3.25); Colorectal-Anal Distress Inventory-8 scores (OR 1.92, 95% CI 1.22-3.02); solitary predominant posterior compartment POP (OR 1.59, 95% CI 1.08-2.35); total vaginal length (OR 0.56, 95% CI 0.32-0.97); wide introitus (OR 4.85, 95% CI 1.60-14.68); levator ani avulsion (OR 2.47, 95% CI 1.35-4.53) and hiatal area on maximum Valsalva (OR 1.89, 95% CI 1.27-2.80). CONCLUSION: During counselling for pessary treatment a higher risk of failure due to the aforementioned parameters should be discussed and modifiable parameters should be addressed. More research is needed on the association between anatomical parameters and specific reasons for unsuccessful pessary fitting.

A randomized trial comparing continence pessary to continence device (Poise Impressa®) for stress incontinence.

INTRODUCTION AND HYPOTHESIS: To conduct a multi-centered randomized trial evaluating stress urinary incontinence (SUI) treatment based on the Patient Global Impression of Improvement score after 4 weeks using a continence pessary (CP) or a disposable intravaginal continence device (DICD). The null hypothesis is no difference in treatment success between cohorts. METHODS: This parallel group, active treatment comparative effectiveness trial randomized women with SUI to either CP or DICD for 4 weeks in a 1:1 allocation ratio. Exclusion criteria included pregnancy, UTI, postmenopausal bleeding, neurogenic bladder, urinary retention, prolapse, contraindication to or prior treatment with CP/DICD, and prior SUI surgery. Assuming an 80% power, an alpha of 5% and 20% dropout, we needed 138 participants to detect 50% success with CP versus 25% with DICD. Due to slow enrollment, the study was stopped after 16 months with 50 participants enrolled. RESULTS: Of the 50 women enrolled, 25 (50%) were randomized to CP and 25 (50%) to DICD. Thirty-five of 50 (70%) completed a fitting, and 22/50 (44%) completed 4-week and 17/50 (34%) completed 6-month follow-up. Baseline characteristics were similar, and there was high treatment success in each cohort [80% (8/10) CP vs. 75% (9/12) DICD; p = 1.0]. DICD patients showed improvement on all questionnaires but had higher use of other therapies over 6 months. CP patients showed improvements except for lower sexual function scores at 4 weeks. No serious adverse events occurred. CONCLUSIONS: Most women fitted with a CP/DICD experienced treatment success after 4 weeks without serious adverse events.

Position and orientation of vaginal pessaries in situ on magnetic resonance imaging.

INTRODUCTION AND HYPOTHESIS: We hypothesize that there are differences in the position and orientation of ring and Gellhorn pessaries in situ on magnetic resonance imaging (MRI). METHODS: This was a retrospective cohort study comparing MRI findings in 25 women with pessaries in situ at the time of imaging. Scanner coordinates for anatomic and pessary landmarks were obtained and transformed to 3D Pelvic Inclination Correction System coordinates using MATLAB software. The normal vector to the pessary disc was computed and compared to the positive y-axis in the sagittal and coronal planes to determine XY and YZ disc angles, respectively. Comparisons between groups were made using Wilcoxon rank, Fisher's exact, and Brown-Forsythe tests. RESULTS: Twenty-one women with ring pessaries and four women with Gellhorn pessaries met inclusion criteria for the study. Women with ring pessaries were younger (68.4 vs. 80.7 years, p = 0.003) but had similar BMI, vaginal parity, history of hysterectomy, and anatomic characteristics. Ring pessaries had a smaller diameter (59.5 vs. 79.3 mm, p = 0.004) and were positioned further posterior with respect to the inferior pubic point (midpoint X position 42.6 vs. 29.5 mm, p = 0.004). There were significant differences in the magnitude and variance of the XY disc angle (57.0 ± 14.0 vs. -1.2 ± 2.8 degrees, p = 0.002 for magnitude, p = 0.012 for variance) but not the YZ disc angle (3.3 ± 30.6 vs. 1.5 ± 7.7 degrees, p > 0.05 for both) between groups. CONCLUSIONS: We found differences in the position and orientation between ring and Gellhorn pessaries in situ using an anatomic 3D reference system. These findings provide insight into the mechanism of action of vaginal pessaries.

Factors associated with unsuccessful pessary fitting and reasons for discontinuation in Korean women with pelvic organ prolapse.

OBJECTIVE: To identify the factors associated with unsuccessful pessary fitting and reasons for pessary discontinuation in Korean women with pelvic organ prolapse (POP). METHODS: The medical records of 234 patients who underwent pessary fitting for the management of symptomatic POP were retrospectively reviewed. A ring pessary with or without support was used. Successful pessary fitting was defined as the ability to wear a pessary for 2 weeks without any discomfort. Factors associated with unsuccessful pessary fitting were determined using a multivariable logistic regression analysis. A Kaplan-Meier survival curve was obtained to examine the probability of continuing pessary use over the follow-up period. The reasons for the discontinuation of pessary were identified. RESULTS: Two-hundred-and-twenty-five women were included in the analysis. The rate of unsuccessful pessary fitting was 40%. Prior hysterectomy (odds ratio [OR], 4.13; 95% confidence interval [CI], 1.81-9.42) and POP quantification stage III-IV (OR, 2.49; 95% CI, 1.28-4.85) were independent risk factors for unsuccessful pessary fitting. Among the patients with successful pessary fitting, the median time to discontinuation of pessary use was 4 years. The most common causes of discontinued use were vaginal erosion (45.3%) and urinary incontinence (26.5%). CONCLUSION: Patients with a history of hysterectomy and advanced-stage POP are at risk for an unsuccessful fitting of the ring pessary. Vaginal erosion is the main reason for discontinued use among patients with successful pessary fitting.

The effect of pessary treatment on puborectalis muscle function.

INTRODUCTION AND HYPOTHESIS: The objective was to assess if puborectalis muscle (PRM) function changes in women with pelvic organ prolapse (POP) undergoing pessary treatment. METHODS: This was a prospective cohort study of women with symptomatic POP choosing pessary treatment. An interview, clinical examination and 3D/4D transperineal ultrasound were performed at baseline and at 3-month follow-up. POP was assessed using the Pelvic Organ Prolapse Quantification system (POPQ). Parameters compared between baseline and follow-up were: hiatal area at rest (HArest), maximal contraction (HActx), and maximal Valsalva maneuver (HAVal), displacement in contraction (DISPL-ctx, i.e., relative difference between HArest and HActx), and displacement in Valsalva (DISPL-Val, i.e., relative difference between and HAVal and HArest). Parameters were compared in women with and those without complete avulsion. RESULTS: A total of 162 women were assessed and 34 were included. Mean age was 64 years (SD 11.4), and mean BMI 24 kg/m2 (SD 3.1). Thirty-one women had a cystocele, 8 a uterine prolapse, and 12 had a posterior compartment prolapse. Twenty-one women (61.8%) had a POP stage II, and 13 (38.2%) a POP stage III. Ring pessaries were most frequently used (97%). In the entire group a statistically significant increase in DISPL-ctx was observed (mean difference 2.1%, p = 0.017). In the no avulsion group HArest and DISPL-ctx increased significantly (mean difference 4.1%, p = 0.016 and 2.7%, p = 0.016 respectively) and the increase in DISPL-ctx was higher than in the avulsion group (mean difference 2.7% vs 0.2%, p = 0.056). CONCLUSION: Our results show that PRM function changes in women with POP undergoing pessary treatment and suggest that such change occurs mainly in the absence of complete avulsion.

[Systematic review of the treatment with pessaries in the pelvic organ prolapse (POP).] / Revisión sistemática del tratamiento con pesarios en el prolapso de órganos pélvicos (POP).

Pelvic organ prolapse (POP) has a general incidence of > 10% in the female population of the Western world. The pessary is a silicone device, inserted into the vagina to provide support to the pelvic organs. It is used as a conservative treatment to improve prolapse symptoms.OBJECTIVES: To evaluate the effectiveness of pessary treatment in pelvic organ prolapse through a systematic review of the current literature.MATERIAL AND METHODS: A Scoping Review was carried out based on the PRISMA guidelines for the development of systematic reviews. The PICO research question was asked, the sources of information were selected, and the eligibility criteria were established. Subsequently, the descriptors in health sciences and keywords, combined with Boolean operators, were appliedin each of the search engines. RESULTS: A total of 19 references were included in the analysis of this work. To delimit the data extraction, the information was divided into four dimensions: improvements in symptoms related to POP and quality of life, sexual function; discontinuation, justification for discontinuation and complications. CONCLUSIONS: The pessary produces positive effects on the quality of life of women with POP, with good satisfaction rates. The main reasons for the interruption include: inability to retain the pessary, discomfort, and the desire for surgery.

El prolapso de órganos pélvicos (POP) presenta una incidencia general de >10% en la población femenina del mundo occidental. El pesario es un dispositivo de silicona, se introduce en la vagina para proveer soporte a los órganos pélvicos. Se utiliza como tratamiento conservador para mejorar los síntomas del prolapso. OBJETIVO: Evaluar la efectividad del tratamiento del pesario en los prolapsos de órganos pélvicos mediante una revisión sistemática de la literatura actual. MATERIAL Y MÉTODOS: Se llevó a cabo una Scoping Review sustentada en las directrices PRISMA para el desarrollo de revisiones sistemáticas. Se planteó la pregunta de investigación PICO, se seleccionaron las fuentes de información y establecieron los criterios de elegibilidad. Posteriormente se aplicaron los descriptores en ciencias de la salud y palabras clave, combinados con operadores boleanos, en cada uno de los buscadores. RESULTADOS: Un total de 19 referencias fueron incluidas en el análisis del presente trabajo. Para delimitar la extracción de datos se procedió a dividir la información en cuatro dimensiones: mejoras en los síntomas relacionados con el POP y la calidad de vida, función sexual; discontinuación, justificación de la interrupción y complicaciones. CONCLUSIONES: El pesario produce efectos positivos en la calidad de vida de las mujeres con POP, con buenas tasas de satisfacción. Las principales razones para la interrupción incluyen: incapacidad de retener el pesario, incomodidad y el deseo de cirugía.