International urogynecology consultation chapter 1 committee 2: Epidemiology of pelvic organ prolapse: prevalence, incidence, natural history, and service needs.

INTRODUCTION AND HYPOTHESIS: This narrative review describes the existing epidemiologic literature and identifies gaps regarding pelvic organ prolapse (POP) prevalence, incidence, natural history, and current and future service needs. MATERIALS AND METHODS: A PubMed search identified relevant citations published in 2000 or later. Pre-specified criteria were used to screen titles, abstracts, and manuscripts, including reference sections. Study findings were summarized to define what is known, identify gaps in current knowledge, and suggest priority areas for future research. RESULTS: The reported prevalence of POP varies widely (1-65%) based on whether its presence is ascertained by symptoms (1-31%), pelvic examination (10-50%), or both (20-65%). Most existing population-based surveys do not include physical examination data. White women from higher income countries are overrepresented in the existing literature. Incidence and natural history data are limited and consist mainly of cohorts that follow women after pregnancy or menopause. Given global increases in aging populations in well-resourced countries, the need for POP treatment is anticipated to increase in the coming decades. In lower and middle income countries (LMICs) where demographic trends are different, there is a dearth of information about anticipated POP service needs. CONCLUSION: Future POP incidence, prevalence, and natural history studies should include non-white women from LMICs and should combine pelvic examination data with validated patient-reported outcome measures when feasible. Anticipated future service needs differ globally, with a greater demand for POP treatment services in well-resourced settings where aging populations are prevalent.

Update in Transvaginal Grafts: The Role of Lightweight Meshes, Biologics, and Hybrid Grafts in Pelvic Organ Prolapse Surgery.

Transvaginal mesh/grafts have been popularized over the past 20 years in an attempt to improve the longevity of traditional vaginal pelvic organ prolapse (POP) surgery. Several national bodies have concluded that the proposed benefits of mesh/graft implantation are outweighed by the significant increase in surgery complications related to these products. As a consequence mesh products for vaginal POP surgery have been withdrawn from use in many countries. This article is a narrative review of newer mesh and graft products including lightweight polypropylene mesh products, biological grafts, hybrid grafts, and tissue engineered grafts.

Does cystoscopy method affect the investigation of bladder pain syndrome/interstitial cystitis?

INTRODUCTION AND HYPOTHESIS: Cystoscopic investigation to identify associated histological findings of increased mast cells in the detrusor muscle has been recommended by the European Society for the Study of Bladder Pain Syndrome (ESSIC) in the investigation of bladder pain syndrome/interstitial cystitis (BPS/IC). The aim of this study was to identify if the cystoscopy approach impacts the biopsy results when investigating women presenting with symptoms of BPS/IC. METHODS: We performed a single-centre retrospective analysis of 300 bladder biopsy reports from 2015 to 2018 from women undergoing cystoscopy for BPS/IC. Biopsies obtained using closed cup forceps through a flexible (FC) or rigid cystoscope (RC) were compared. RESULTS: Fifty-eight FC biopsies were compared with 242 RC biopsies. FC biopsies had a smaller mean diameter (1.6 mm vs 2.9 mm p < 0.01) and volume (4.1 mm3 vs 9.6 mm3 p < 0.001) compared with RC biopsies. There was no significant difference in the histological depth of sampling to the muscularis propria. A total of 292 samples had CD117 immunohistochemical staining for mast cell count (MCC) analysis. The MCC/mm2 was significantly lower in FC biopsies (p < 0.01). Sixteen percent of FC samples compared with 60% of RC samples had a high MCC >28/mm2 (p < 0.01). There was no significant difference in positive microbiology culture between FC (21%) and RC (28%) sampling. CONCLUSION: Rigid and flexible cystoscopy can be used to investigate BPS/IC as recommended by international societies. However, the biopsy method impacts the mast cell count analysis, which can influence diagnosis and management. Therefore, RC would be the optimal investigation.

Interstitial cystitis/bladder pain syndrome and recurrent urinary tract infection and the potential role of the urinary microbiome.

Interstitial cystitis/bladder pain syndrome and recurrent urinary tract infections carry significant burden for those affected. As women enter the menopause, other factors may influence how these conditions manifest. The urinary microbiome has shown that the urine contains extensive numbers of bacteria. There is some evidence to suggest that it is altered depending on the menopausal state of the individual. It is possible that this alteration may go on to influence how the disease course of interstitial cystitis/bladder pain syndrome and recurrent urinary tract infections runs in the post-menopausal group. The review will explore these two conditions and the potential role of the urinary microbiome.

Does size matter? Perineometer and digital examination of a model levator hiatus.

INTRODUCTION: Evaluation of the female pelvic floor muscles is commonly carried out with digital examination and assigning a modified Oxford scale score or vaginal manometry. Racial differences can influence the size of the levator hiatus (LH) with "black" or African nulliparous women having a significantly larger LH compared to Caucasian women. The aim of this study was to assess the impact of LH size on manometry readings of simulated pelvic floor muscle contractions (PFMCs) using a small and large model LH. METHODS: Small and large LH models were created using published data for size. Inflation of a pressure cuff placed circumferentially in the LH model represented a simulated PFMC. The models were examined in a supine position by three examiners and a perineometer twice each at varying simulated PFMC strength. RESULTS: Positive correlation was found between increasing simulated PFMC strength with a higher Oxford score following digital examination and manometry readings for both the small (rs = .87, rs = .98) and large (rs = .95, rs = .87) models. There was good to excellent inter and intraobserver correlation for digital assessment of both models. The manometry measurements showed a much larger incremental rise from baseline in the small model compared with the large model (P < .05). CONCLUSION: This study demonstrates that perineometer readings are affected by natural variations in LH size and PFMC strength. Therefore improvement to pelvic floor strength cannot be interpreted and measurements cannot be compared with others unless the LH size is known or digital examination is carried out.

Vaginal laser for overactive bladder syndrome.

Overactive bladder syndrome (OAB) is defined as urinary urgency, usually with urinary frequency and nocturia, with or without urge urinary incontinence. The prevalence of OAB in adult women ranges between 11% and 42%, is particularly common in elderly people, and can overlap with the genitourinary syndrome of menopause (GSM). There is a wide approach to the treatment of symptoms, often in a stepwise fashion, including lifestyle changes, bladder retraining and pelvic floor muscle rehabilitation, drug therapy, intra-vesical botulinum toxin injections or neuromodulation. Recently, vaginal laser therapy has been proposed as an emerging minimal invasive effective treatment option for women with OAB. We explore this further.

The role of bladder instillation in the treatment of bladder pain syndrome: Is intravesical treatment an effective option for patients with bladder pain as well as LUTS?

The aetiology of bladder pain syndrome/interstitial cystitis is still unknown. Numerous mechanisms have been proposed and treatments targeting various aspects of these are used. This review looks at the existing evidence on bladder instillations and whether they could be used in the treatment of lower urinary tract symptoms as well.

3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome.

PURPOSE: We evaluated the 3-year safety and efficacy of the BlueWind Medical RENOVA™ iStim system for the treatment of overactive bladder syndrome. MATERIALS AND METHODS: All patients who previously underwent implantation with the RENOVA system were offered continued participation. The primary long-term study end point was to evaluate the safety profile based on incidence of serious adverse events (system and/or procedure related), which was measured by the impact and frequency of serious adverse events. The secondary end points included clinical improvement compared to baseline and quality of life improvement compared to baseline at 36 months, which was measured by 3-day voiding diary and quality of life questionnaires at certain time points. RESULTS: Of the 34 patients with overactive bladder syndrome who previously underwent implantation with the RENOVA system 20 consented to continuation in this 3-year followup study. Mean patient age was 56.1 years and 80% (16) of the study cohort was female. The overall treatment success rate was 75% at 36 months in the per protocol (16) and the intent to treat (20) analyses. In total, 73% of the patients reported improvement in health related quality of life scores above the minimal important difference of 10 points. CONCLUSIONS: This 3-year followup study using the BlueWind RENOVA iStim system for the treatment of overactive bladder syndrome symptoms confirms the long-term good safety profile with no technical failures reported. Lasting treatment efficacy is mirrored by a sustained positive impact on patient quality of life.

Posterior tibial nerve stimulation for overactive bladder-techniques and efficacy.

The ideal treatment for overactive bladder is still elusive. In those where medication fails to improve symptoms options include invasive treatments such as botulinum toxin-A, sacral neural stimulation or posterior tibial nerve stimulation. Scientific professional society guidelines advise percutaneous posterior tibial nerve stimulation as a third line treatment option only after multi-disciplinary team review as well as failure of both conservative and pharmacological management. The aim of this article is to review all techniques for tibial nerve stimulation and their efficacy.

The Clinical Role of LASER for Vulvar and Vaginal Treatments in Gynecology and Female Urology: An ICS/ISSVD Best Practice Consensus Document.

In this best practice document, we propose recommendations for the use of LASER for gynecologic and urologic conditions such as vulvovaginal atrophy, urinary incontinence, vulvodynia, and lichen sclerosus based on a thorough literature review. Most of the available studies are limited by their design; for example, they lack a control group, patients are not randomized, follow-up is short term, series are small, LASER is not compared with standard treatments, and most studies are industry sponsored. Because of these limitations, the level of evidence for the use of LASER in the treatment of these conditions remains low and does not allow for definitive recommendations for its use in routine clinical practice. Histological evidence is commonly reported as proof of tissue regeneration after LASER treatment. However, the histological changes noted can also be consistent with reparative changes after a thermal injury rather than necessarily representing regeneration or restoration of function. The use of LASER in women with vulvodynia or lichen sclerosus should not be recommended in routine clinical practice. There is no biological plausibility or safety data on its use on this population of women. The available clinical studies do not present convincing data regarding the efficacy of LASER for the treatment of vaginal atrophy or urinary incontinence. Also, although short-term complications seem to be uncommon, data concerning long-term outcomes are lacking. Therefore, at this point, LASER is not recommended for routine treatment of the aforementioned conditions unless part of well-designed clinical trials or with special arrangements for clinical governance, consent, and audit.

The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology: An ICS/ISSVD best practice consensus document.

BACKGROUND: The clinical role of LASER for vulvar and vaginal treatments in gynecology and female urology is controversial. AIMS: In this best practice document, we propose recommendations for the use of LASER for gynecologic and urologic conditions such as vulvovaginal atrophy, urinary incontinence, vulvodynia, and lichen sclerosus based on a thorough literature review. MATERIALS & METHODS: This project was developed between January and September 2018. The development of this document followed the ICS White Paper Standard Operating Procedures. RESULTS: Most of the available studies are limited by their design; for example they lack a control group, patients are not randomized, follow up is short term, series are small, LASER is not compared with standard treatments, and studies are industry sponsored. Due to these limitations, the level of evidence for the use of LASER in the treatment of these conditions remains low and does not allow for definitive recommendations for its use in routine clinical practice. Histological evidence is commonly reported as proof of tissue regeneration following LASER treatment. However, the histological changes noted can also be consistent with reparative changes after a thermal injury rather than necessarily representing regeneration or restoration of function. The use of LASER in women with vulvodynia or lichen sclerosus should not be recommended in routine clinical practice. There is no biological plausibility or safety data on its use on this population of women. DISCUSSION: The available clinical studies do not present convincing data regarding the efficacy of LASER for the treatment of vaginal atrophy or urinary incontinence. Also, while short-term complications seem to be uncommon, data concerning long-term outcomes are lacking. CONCLUSION: At this point, LASER is not recommended for routine treatment of the aforementioned conditions unless part of well-designed clinical trials or with special arrangements for clinical governance, consent, and audit.

The energy based devices for vaginal "rejuvenation," urinary incontinence, vaginal cosmetic procedures, and other vulvo-vaginal disorders: An international multidisciplinary expert panel opinion.

AIMS: Energy-based devices using radiofrequency and laser technologies have gained popularity as therapies for vaginal atrophy, urinary incontinence, and vaginal prolapse. They have been promoted by cosmetic and aesthetic industries for vaginal "laxity" and vaginal "rejuvenation," both of which are undefined conditions and terms. This article aims to review the current available literature and its quality on this emerging technology. METHODS: An international panel of gynaecologists, urogynaecologists, and urologists undertook a review of the available published literature, identifying articles, guidance, and society statements on the use vaginal energy-based devices. RESULTS: There is currently no formal guidance for the use of vaginal energy based therapies. No randomized controlled trials have been published. No comparative studies to existing treatment has been carried out. Studies suggest that vaginal laser can be used in the treatment of vaginal prolapse or "vaginal laxity" and stress urinary incontinence with no quality evidence supporting the use of the therapy for vaginal atrophy or lichen sclerosis. CONCLUSIONS: This international group propose that whilst there remains a paucity of good quality data describing the safety, benefits, and appropriate use of vaginal radiofrequency or laser treatments in gynaecology and urogynaecology, a consensus best practice document by an established scientific community needs to be developed.