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Aims To evaluate whether the treatment based on urodynamics (UDS) leads to better treatment response compared to where the treatment is based on symptoms alone. Study design, materials and methods All patients referred with lower urinary tract symptoms (LUTS) were offered the opportunity to participate in this patient preference trial. Patients were asked to complete a Kings Health Questionnaire (KHQ) and a 3-day bladder diary. The patients were then offered treatment based on their preference for conservative therapy based on either symptoms alone or with additional UDS or randomization to the same two alternatives, if they had no preference. The primary outcomes studied were improvement in KHQ and reduction in Incontinence Episode Frequency (IEF) at 6 months. Logistic regression analysis was done to evaluate the effect of choice of treatment and effect of incontinence on KHQ. Results There was no statistically significant difference between the KHQ scores pre and post UDS in patient preference or randomized groups. Follow up attendance rates were significantly better in those who chose to undergo urodynamics when compared to those who chose conservative treatment. Conclusions This study suggests although UDS does not improve IEF, it may have utility in patient choice and subsequent compliance. Another relevant finding was the previously unreported high uptake of UDS by women when given the choice of whether to undergo UDS first or have treatment based on symptoms alone. Neurourol. Urodynam. 29:522-526, 2010. © 2009 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

Aims To assess the effectiveness and safety of administering prophylactic antibiotics in reducing the risk of urinary tract infection (UTI) after urodynamic studies (UDS). Methods The CENTRAL, MEDLINE, EMBASE, CINAHI, LILIACS (up to January 2007), TRIP database, The National Library for Health, the citation lists of review articles, conference abstracts (2004-2006) and hand search of reference lists to identify relevant reviews and articles. Randomised controlled trials (RCTs) comparing effectiveness of prophylactic antibiotics with placebo or nothing in reducing bacteriologically proven UTI after invasive cystometry were included. Two reviewers extracted data independently and the results were expressed as peto odds ratio with 95% confidence intervals using fixed effects model in ReV Man 4.2.8 software. Results Eight RCTs with 995 patients were included. The majority of the patients were female. The studies were methodologically poor. The primary outcome in all but one study was newly acquired infection defined as colony count >105/ml in urine tested post UDS. On meta-analysis, there was 40% reduction in the risk of significant bacteriuria with administration of prophylactic antibiotics (Peto odds ratio 0.39; 95% confidence interval 0.24-0.61). The antibiotics used differed in dose, type and duration. One minor skin rash and one major anaphylactic reaction requiring steroid injection therapy was reported in the treatment group. One would need to give prophylactic antibiotics to 13 individuals undergoing UDS to prevent one significant bacteriuria of unknown clinical significance. Conclusion The use of prophylactic antibiotics in urodynamics reduces the risk of significant bacteriuria. Neurourol. Urodynam. 27:167-173, 2008. © 2007 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

: ObjectiveTo determine whether transvaginal ultrasound measurement of bladder wall thickness could replace ambulatory urodynamics when investigating women with lower urinary tract dysfunction not explained by conventional laboratory urodynamic studies.: DesignA blinded prospective study.: SettingTertiary referral unit in a London teaching hospital.: PopulationOne hundred and twenty-eight women referred for ambulatory urodynamics with equivocal laboratory urodynamic findings or whose symptoms were not explained by the laboratory urodynamic findings.: MethodsTransvaginal ultrasound assessment of bladder wall thickness was performed in three planes with an empty bladder prior to ambulatory urodynamics. Mean bladder wall thickness was calculated and the results analysed with respect to the ambulatory urodynamic diagnosis.: Main outcome methodsMean bladder wall thickness in women with a normal ambulatory study or a diagnosis of detrusor instability, genuine stress incontinence (GSI) or mixed incontinence.: ResultsUsing a one way analysis of variance (ANOVA) bladder wall thickness was found to be significantly different in all diagnostic groups and this reached significance (P = 0.0001). There was no overlap in the 95% confidence intervals representing a diagnosis of detrusor instability or genuine stress incontinence.: ConclusionsTransvaginal ultrasound assessment of mean bladder wall thickness is a sensitive screening tool, which can detect detrusor instability in those women with equivocal laboratory urodynamics. In women who have no evidence of GSI on laboratory studies, a cutoff of 6.0mm is highly suggestive of detrusor instability. However, in those women with GSI then ambulatory studies probably remain the investigation of choice. [ABSTRACT FROM AUTHOR]

Background: Overactive bladder (OAB) affects one in six adults in Europe and the United States and impairs the quality of life of millions of individuals worldwide. When conservative management fails, third-line treatments including tibial neuromodulation (TNM) is often pursued. TNM has traditionally been accomplished percutaneously in clinic., Objective: A minimally invasive implantable device activated by a battery-operated external wearable unit has been developed for the treatment of urgency urinary incontinence (UUI), mitigating the burden of frequent clinic visits and more invasive therapies that are currently commercially available., Methods: A prospective, multicenter, single-arm, open-label, pivotal study evaluated the safety and effectiveness of the device in adult females with UUI (i.e., wet OAB) (BlueWind Implantable Tibial Neuromodulation [iTNM] system; IDE number #G200013; NCT03596671). Results with the device were previously published under the name RENOVA iStim, which has been since renamed as the Revi™ System. Approximately 1-month post-implantation of the device, participants delivered therapy at their convenience and completed a 7-day voiding diary before visits 6- and 12-months post-treatment initiation. The primary efficacy and safety endpoints were the proportion of responders to therapy ( ≥ 50% improvement on average number of urgency-related incontinence episodes) and incidence of adverse events from implantation to 12-month post-activation., Results: A total of 151 participants, mean age 58.8 (SD: 12.5), were implanted; 144 and 140 completed the 6- and 12-month visits, respectively. The participants demonstrated mean baseline of 4.8 UUI/day (SD 2.9) and 10 voids/day (SD 3.3). Six and 12-months post-activation, 76.4% and 78.4% of participants, respectively, were responders to therapy in an intent-to-treat analysis. Of the 139 participants with completed 12-month diaries, 82% were responders, 50% were classified as "dry" (on at least 3 consecutive diary days), and 93.5% of participants reported that their symptoms improved. No implanted participant experienced an SAE related to the procedure or device., Conclusions: iTNM, delivered and powered by a patient-controlled external wearable communicating with an implant, demonstrated clinically meaningful and statistically significant improvement in UUI symptoms and a high safety profile. This therapy highlights the value of patient-centric therapy for the treatment of UUI., (© 2024 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)

Background: Second trimester miscarriage and preterm birth is a significant global problem. Surgical cervical cerclage is performed to prevent pregnancy loss and preterm birth. It utilises either a monofilament or braided suture. It is hypothesised that a braided material becomes colonised with pathogenic bacteria that causes vaginal dysbiosis, infection and cerclage failure., Objectives: The primary objective of the study was to examine the effectiveness of using a monofilament suture material as opposed to a braided suture material on pregnancy loss in women requiring a vaginal cervical cerclage., Design: Superiority open randomised controlled trial., Setting: Seventy-five maternity sites across the UK., Participants: Women experiencing a singleton pregnancy requiring a cervical cerclage., Interventions: Monofilament suture or braided suture., Main Outcome Measures: The primary outcome was pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life). Secondary outcomes included the core outcome set for preterm birth., Methods: Women were randomised on a 1 : 1 basis to monofilament or braided cerclage utilising a bespoke randomisation service with minimisation dependent on the site, indication for cerclage, intention to use progesterone and planned surgical technique. The inclusion criteria were three or more previous mid-trimester losses or preterm births, insertion of a cerclage in a previous pregnancy, a history of a mid-trimester loss or preterm birth with a shortened cervical length in the current pregnancy or in women who clinicians deemed at risk of preterm birth. The exclusion criteria were an emergency or rescue cerclage, age of < 18 years, being unable to give informed consent or the cerclage having to be placed abdominally. The original sample size was calculated based on a relative risk reduction of 41% from a pregnancy loss rate of 19% in the braided group to 11% in the monofilament group with 90% power and alpha at p = 0.05. The independent data monitoring committee noted a lower-than-anticipated pooled event rate within the trial and recommended an increase in sample size to 2050. The outcome data were collected using clinical record forms from the maternal and neonatal medical records and reported to Birmingham Clinical Trials Unit., Results: A total of 2049 women were randomised, after withdrawals and loss to follow-up, data on 1005 women in the monofilament group and 993 women in the braided group were included. The baseline demographics between the groups were similar. There was no evidence of a difference in pregnancy loss rates between the monofilament and braided groups (80/1003 vs. 75/993; adjusted risk ratio: 1.05, 95% confidence interval: 0.79 to 1.40; adjusted risk difference: 0.002, 95% confidence interval: -0.02 to 0.03)., Limitations: The trial did not collect long-term paediatric outcomes. There were no safety concerns., Conclusions: There was no evidence of a difference in pregnancy loss between a monofilament suture and a braided suture., Future Work: Long-term follow-up of neonates born within the C-STICH (cerclage suture type for an insufficient cervix and its effects on health outcomes) trial., Trial Registration: This trial is registered as ISRCTN15373349., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/04/107) and is published in full in Health Technology Assessment ; Vol. 28, No. 40. See the NIHR Funding and Awards website for further award information.

Background: Bladder diaries represent a fundamental component in the assessment of patients presenting with lower urinary tract symptoms. Nevertheless, their importance often remains underappreciated and undervalued within clinical practice. This paper aims to conduct a comprehensive review of the existing literature concerning the utility of bladder diaries, underscore the criticality of their precision, elucidate the factors contributing to noncompliance with bladder diary completion, and investigate potential strategies for enhancing patient compliance., Materials and Methods: A review of the English-language scientific literature available in the domains of Medline, Embase, Emcare, Midirs, and Cinahl was conducted. This was supplemented by discussion at the International Consultation on Incontinence Research Society Proposal session to define knowledge and identify gaps in knowledge surrounding the utility of bladder diaries. The existing evidence and outcome of the relevant discussion held in the meeting are presented., Results: Bladder diaries (BD) serve to characterize the nature and severity of storage lower urinary tract symptoms (LUTS) and provide an objective record of an individual's urination patterns. They aid in the refinement and customization of treatment strategies based on the clinical responses documented in the diary, optimizing treatment outcomes. Notably, both BD and urodynamic studies (UDS) play complementary yet distinct roles in LUTS evaluation. BD offers a more comprehensive and accessible approach to assessing specific storage LUTS, particularly due to their affordability and widespread availability, especially in resource-limited settings. Nevertheless, the absence of a standardized BD format across global healthcare systems presents a significant challenge. Despite being recognized as reliable, noninvasive, validated, and cost-effective tools for evaluating patients with LUTS, the implementation and completion of BD have proven to be complex. The introduction of automated bladder diaries heralds an era of precise, real-time data collection, potentially enhancing the patient-clinician relationship. Completion of bladder diaries depends on an array of individual, social, and healthcare-specific factors. Compliance with bladder diary completion could be enhanced with clear instructions, patient education, regular follow-ups and positive re-enforcement. This study has identified four critical areas for future research: Addressing healthcare disparities between affluent and developing nations, enhancing the current functionality and effectiveness of bladder diaries, exploring the feasibility of incorporating bladder diaries into the treatment and education process and improving the quality and functionality of existing bladder diaries., Conclusion: Bladder diaries play a pivotal role in the evaluation and management of patients with LUTS, providing a holistic perspective. When their complete potential is harnessed, they have the capacity to revolutionize the paradigm of LUTS management, ushering in a patient-centered era of care., (© 2023 Wiley Periodicals LLC.)

Objective: To evaluate the efficacy and safety of non-ablative vaginal Er:YAG laser device in stress urinary incontinence (SUI) treatment., Methods: We conducted a multicenter blinded randomized sham-controlled trial in which women with urodynamic SUI were randomization to active arm using Er:YAG laser therapy, and sham arm using sham handpiece. Patients received two treatments 1 month apart. The primary outcomes measure was 1 h pad weight test measured at 6 months. Secondary outcomes were durability of treatment success at 12 months, and questionnaires for assessment of SUI severity (ICIQ-UI SF), sexual function (PISQ-12) and HRQoL (KHQ), and incidence and severity of device related adverse events and pain (VAS)., Results: A total of 110 participants with SUI were recruited; 73 in the active arm and 37 in the sham arm. Two participants were excluded; one was assigned the wrong treatment and one withdrew their consent. Treatment success was observed in 36% of the sham arm and 59% of the active arm; in the latter, odds of achieving treatment success were more than three-fold higher (OR 3.63, 95% CI: 1.3-11.2, P = 0.02). HRQoL by KHQ showed significant improvement in the active versus the sham arm (OR 0.36, 95% CI: 0.15-0.87, P = 0.003). Similarly, subjective patient assessment of general and sexual function improvement with PISQ-12 and PGI-I showed superior effect over sham (OR 2.8, 95% CI: 1.2-7.0, P = 0.02 and OR 0.13, 95% CI: 0.05-0.36, P < 0.001, respectively)., Conclusion: Non-ablative vaginal Er:YAG laser therapy significantly improves SUI symptoms versus sham treatment. Er:YAG laser therapy should be considered as a non-surgical treatment option for SUI patients., (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

Introduction and Hypothesis: This manuscript of Chapter 4 of the International Urogynecological Consultation (IUC) on Pelvic Organ Prolapse (POP) reviews the literature and makes recommendations on the definition of success in the surgical treatment of pelvic organ prolapse., Methods: An international group containing seven urogynecologists performed an exhaustive search of the literature using two PubMed searches and using PICO methodology. The first search was from 01/01/2012-06/12/2022. A second search from inception to 7/24/2022 was done to access older references. Publications were eliminated if not relevant to the clinical definition of surgical success for the treatment of POP. All abstracts were reviewed for inclusion and any disagreements were adjudicated by majority consensus of the writing group. The resulting list of articles were used to inform a comprehensive review and creation of the definition of success in the surgical treatment of POP., Outcomes: The original search yielded 12,161 references of which 45 were used by the writing group. Ultimately, 68 references are included in the manuscript. For research purposes, surgical success should be primarily defined by the absence of bothersome patient bulge symptoms or retreatment for POP and a time frame of at least 12 months follow-up should be used. Secondary outcomes, including anatomic measures of POP and related pelvic floor symptoms, should not contribute to a definition of success or failure. For clinical practice, surgical success should primarily be defined as the absence of bothersome patient bulge symptoms. Surgeons may consider using PASS (patient acceptable symptom state) or patient goal attainment assessments, and patients should be followed for a minimum of at least one encounter at 6-12 weeks post-operatively. For surgeries involving mesh longer-term follow-up is recommended., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Aims: Obstetric anal sphincter injury (OASI) is associated with long-term anal incontinence (AI). We aimed to address the following questions: (a) are women with major OASI (grade 3c and 4) at higher risk of developing AI when compared to women with minor OASI (grade 3a and 3b)? (b) is a fourth-degree tear more likely to cause AI over a third-degree tear?, Methods: A systematic literature search from inception until September 2022. We considered prospective and retrospective cohort studies, cross-sectional and case-control studies without language restrictions. The quality was assessed by the Newcastle-Ottawa Scale and the Joanna Briggs Institute critical appraisal checklist. Risk ratios (RRs) were calculated to measure the effect of different grades of OASI., Results: Out of 22 studies, 8 were prospective cohort, 8 were retrospective cohort, and 6 were cross-sectional studies. Length of follow-up ranged from 1 month to 23 years, with the majority of the reports (n = 16) analysing data within 12-months postpartum. Third-degree tears evaluated were 6454 versus 764 fourth-degree tears. The risk of bias was low in 3, medium in 14 and high in 5 studies, respectively. Prospective studies showed that major tears are associated with a twofold risk of AI for major tears versus minor tears, while retrospective studies consistently showed a risk of fecal incontinence (FI) which was two- to fourfold higher. Prospective studies showed a trend toward worsening AI symptoms for fourth-degree tears, but this failed to reach statistical significance. Cross-sectional studies with long-term (≥5 years) follow-up showed that women with fourth-degree tear were more likely to develop AI, with an RR ranging from 1.4 to 2.2. Out of 3, 2 retrospective studies showed similar findings, but the follow-up was significantly shorter (≤1 year). Contrasting results were noted for FI rates, as only 5 out of 10 studies supported an association between fourth-degree tear and FI., Conclusions: Most studies investigate bowel symptoms within few months from delivery. Data heterogeneity hindered a meaningful synthesis. Prospective cohort studies with adequate power and long-term follow-up should be performed to evaluate the risk of AI for each OASI subtype., (© 2023 Wiley Periodicals LLC.)

Obesity is a growing condition within the society and more patients, who have underlying obesity, are presenting with lower urinary tract symptoms (LUTS) and pelvic floor dysfunction (PFD). The effect of obesity on general health has been well documented, and its impact on the cardiovascular, endocrine, and musculoskeletal systems has been extensively studied. There is now a growing body of evidence on the effects of obesity on the female urogenital system. It seems to influence the prevalence, presentation, assessment, management, and outcome of various types of LUTS and PFD. A holistic approach is needed to assess and manage these patients. A clear understanding of the functions of the pelvic floor and the way it can be affected by obesity is essential in providing holistic care to this group. A frank discussion about patient weight is required in the clinics handling PFD. A multimodal approach to weight loss would help improve PFD symptoms and progression. Patients with obesity should still be offered standard treatment options for all PFDs and should not be forced to lose weight as a prerequisite before starting treatment. However, they should also be made aware of the impediments that being overweight adds to their care and their expectations should be managed accordingly., Competing Interests: Declaration of competing interest None to declare., (Copyright © 2023. Published by Elsevier Ltd.)

Genitourinary syndrome of menopause (GSM) is the term used to describe the group of symptoms including vaginal pain, vaginal dryness, itching, pain during sexual intercourse and fragile vaginal tissues as well as urinary symptoms including urinary frequency, urgency, incontinence, blood in the urine (haematuria) and recurrent urinary tract infections that occur due to a lack of the hormone estrogen. These symptoms can have a significant negative impact on psychosexual issues, sexual function and quality of life in postmenopausal women. Traditionally women have been treated with vaginal lubricants, vaginal moisturisers or low-dose vaginal estrogens. Lasers have been used in the cosmetic industry for collagen remodelling and repair of the skin. Therefore, it has been suggested that laser therapy may be used on the vagina as an alternative treatment for GSM. A review of all the published studies assessing the safety and efficacy of laser therapy for GSM have shown promising beneficial results. The majority of studies to date have been small, short-term, observational studies. However, there are randomised controlled trials underway. Laser treatment may be beneficial for the symptoms of GSM but until more robust evidence is available it should not be adopted into widespread practice, and should be used as part of a research study only., (© 2022 Royal College of Obstetricians and Gynaecologists.)

Background: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage., Methods: C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349., Findings: Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03])., Interpretation: Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes., Funding: National Institute of Health Research Health Technology Assessment Programme., Competing Interests: Declaration of interests VHM is a National Institute for Health and Care Research (NIHR) clinical lecturer and has received an honorarium from Hologic. JD reports membership of the NIHR Clinical Trials Unit Standing Advisory Committee (May 1, 2016, to Sept 30, 2023). JEN is a member of the Health Technology Assessment (HTA) Maternal, Neonatal and Child Health Panel; receives funding from NIHR Efficacy and Mechanism Evaluation programme; participates in a Data Monitoring and Ethics Committee for GlaxoSmithKline; and is a paid consultant for DILAFOR. RKM receives funding from NIHR HTA and programme grants for Applied Health Research schemes; is a steering committee member of the Saving Babies Lives Care Bundle; and a paid Clinical Advisory Board member for Surepulse (a company designing neonatal monitors). All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Preterm birth is associated with significant mortality and morbidity for mothers and babies. Women are identified as high risk for preterm birth based on either previous medical/pregnancy history or on ultrasound assessment of the cervix. Women identified as high risk can be offered a cervical cerclage (a purse string stitch) around the cervix (neck of the womb) to reduce the risk of preterm birth. In women who have a cervical cerclage, the procedure can be performed using either a monofilament (single-stranded) or braided (woven) suture material. Both suture materials are routinely used for cervical cerclage and there is uncertainty as to which is superior., Methods: A multicentre, open, randomised controlled superiority trial of 2050 women presenting at obstetric units, deemed to be at risk of preterm birth and already scheduled to have a cervical cerclage as part of their standard care. Inclusion criteria include singleton pregnancies and an indication for cervical cerclage for either a history of three or more previous mid-trimester losses or premature births (≤ 28 weeks), insertion of cervical sutures in previous pregnancies, a history of mid trimester loss or premature birth with a (current) shortened (≤ 25 mm) cervix, or women whom clinicians deem to be at risk of preterm birth either by history or the results of an ultrasound scan. Exclusion criteria include women who have taken part in C-STICH previously, are aged less than 18 years old at the time of presentation, require a rescue cerclage, and are unwilling or unable to give informed consent and in whom a cerclage will be placed by any route other than vaginally (e.g. via an abdominal route). Following informed consent, women are randomised on a 1:1 basis to either monofilament or braided suture, by minimisation. The primary outcome is pregnancy loss (miscarriage and perinatal mortality, including any stillbirth or neonatal death in the first week of life), and secondary outcomes include the core outcome set for preterm birth trials., Discussion: Optimising established interventions to prevent preterm birth is important in reducing perinatal mortality rates., Trial Registration: ISRCTN 15373349 . Registered before recruitment on 03 December 2014 prior to first recruit., (© 2021. The Author(s).)

Background: Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and the potential benefits of cerclage are less certain. A randomised control trial is needed to accurately assess the effectiveness of ECC in preventing pregnancy loss compared to an expectant approach., Methods: C-STICH2 is a multicentre randomised controlled trial in which women presenting with cervical dilatation and unruptured exposed membranes at 16 + 0 to 27 + 6 weeks gestation are randomised to ECC or expectant management. Trial design includes 18 month internal pilot with embedded qualitative process evaluation, minimal data set and a within-trial health economic analysis. Inclusion criteria are ≥16 years, singleton pregnancy, exposed membranes at the external os, gestation 16 + 0-27 + 6 weeks, and informed consent. Exclusion criteria are contraindication to cerclage, cerclage in situ or previous cerclage in this pregnancy. Randomisation occurs via an online service in a 1:1 ratio, using a minimisation algorithm to reduce chance imbalances in key prognostic variables (site, gestation and dilatation). Primary outcome is pregnancy loss; a composite including miscarriage, termination of pregnancy and perinatal mortality defined as stillbirth and neonatal death in the first week of life. Secondary outcomes include all core outcomes for PTB. Two-year development outcomes will be assessed using general health and Parent Report of Children's Abilities-Revised (PARCA-R) questionnaires. Intended sample size is 260 participants (130 each arm) based on 60% rate of pregnancy loss in the expectant management arm and 40% in the ECC arm, with 90% power and alpha 0.05. Analysis will be by intention-to-treat., Discussion: To date there has been one small trial of ECC in 23 participants which included twin and singleton pregnancies. This small trial along with the largest observational study (n = 161) found ECC to prolong pregnancy duration and reduce deliveries before 34 weeks gestation. It is important to generate high quality evidence on the effectiveness of ECC in preventing pregnancy loss, and improve understanding of the prevalence of the condition and frequency of complications associated with ECC. An adequately powered RCT will provide the highest quality evidence regarding optimum care for these women and their babies., Trial Registration: ISRCTN Registry ISRCTN12981869 . Registered on 13th June 2018., (© 2021. The Author(s).)

Introduction and Hypothesis: The IUGA special interest group (SIG) identified a need for a minimum data set (MDS) to inform outcome measurements to be included and simplify data capture and standardise reporting for data collection systems. To define a minimum data set for urogynaecological surgical registries., Methods: Existing registries provide an inventory of items. A modified Delphi approach was used to identify a MDS. At each stage reviewers ranked data points and used free text to comment. The rating used a scale of 0-10 at each review and a traffic light system rated the scores as desirable, highly desirable and mandatory. The scores were collated and reported back to clinicians prior to the further rounds. Outliers were highlighted and reviewers re-assessed prior to repeating the process. A comparison of the MDS was made with published outcomes., Results: Reviewers were from the outcome SIG with emphasis on widespread representation. Fifteen clinicians from eight countries were involved. Four reviewers dissected the existing databases. Eighty data points were considered in four categories, background, preoperative, intraoperative and postoperative. Consensus was reached by the third round. Two points were added on review (date of surgery and urodynamics). Three background points, five preoperative points, seven intraoperative points and nine postoperative points were identified giving 24 minimum data points in the final recommendation., Conclusions: An MDS has been developed for urogynaecological surgical registries. These should be mandatory points which then allow larger varying points to be assessed. These points correspond well to data points used in published papers from established databases.

Introduction and Hypothesis: The aim of this study was to assess the impact of botulinum toxin injection in women with myofascial pelvic pain (MFPP) syndrome of the pelvic floor who had failed conservative treatment., Methods: This was a retrospective descriptive observational study of 48 consecutive patients receiving botulinum toxin to the pelvic floor for MFPP syndrome in a tertiary teaching hospital over an 8-year period. Trigger points were identified, and botulinum toxin was injected into the pelvic floor at the trigger points in doses ranging from 50 to 200 units. The patient-reported global impression of improvement scale was used to evaluate the success at follow-up, and adverse effects were recorded., Results: Forty-six women attended for follow-up at 3-6 months. Of these, 34 (74%) reported an improvement in their symptoms (slightly better, much better, very much better), 12 (26%) had no change, and no patients reported worsening of symptoms. One patient (2%) reported transient postoperative faecal incontinence, which resolved after 2 weeks. There appeared to be no difference in outcome between the doses., Conclusions: Botulinum toxin injection into the pelvic floor of women with MFPP appears to be beneficial in those who have failed conservative treatment. Prospective studies, including dose-finding studies, are now required.

Indroduction & Hypothesis: Women having Vaginal Birth (VB) have different soft tissue dynamics to women requiring emergency Lower Section Caesarean Section (LSCS)., Aims: To assess the role of ultrasound in the assessment of LH distensibility in predicting outcomes for women wishing for Vaginal Birth After Caesarean section (VBAC). To inform subsequent trial design including understanding womens attitudes to the use of ultrasound in prediction of vaginal birth., Methods: Nulliparous, previous VB and previous LSCS underwent a transvaginal ultrasound. This scan looked at the distensibility of the LH and then correlated with mode of birth. Analysis used logistic regression and ROC curves analysis for static measurements and distensibility. A second cohort was also asked about their views as to the usefulness of such a tool to help inform on the utility of such a model., Results: The original hypothesis confirmed maternal BMI, Anterior Posterior (AP) diameter at rest and AP distensibility all being significant predictors of VB in nulliparous women. As expected this relationship was also seen in women who had previously had a vaginal birth. Of the VBAC group, 23 women had LSCS. Five were Robson category, 18 had emergency LSCS in labour. 25 women had VB. Whilst there were trends towards lesser distensibility in VBAC women who delivered vaginally, none of these reached sgnificance. The concept of the use of scanning to inform women as to likelihood of successful vaginal birth was supported by the survey., Conclusion: Previously noted characteristics in nulliparous women for pelvic floor distension were confirmed. This relationship was not demonstrated for the VBAC cohort. We were unable to establish criteria for a simple ultrasound model to predict VB in women wishing for VBAC. Overall, women would welcome such model if it were available., (© 2021 Published by Elsevier B.V.)

Introduction and Hypothesis: This qualitative interview study explores aspects women with urinary incontinence(UI) reflect upon when considering whether or not to have surgery. Conducted prior to the recent mesh pause in the UK, the article provides insights for current and future approaches to shared decision-making., Methods: Qualitative in-depth interviews of 28 patients referred to secondary care for stress and mixed UI who were considering UI surgery. Participants were recruited from four urogynaecology clinics in the Midlands and South England, UK. Interviews were conducted in clinics, in patient homes, and by telephone. Data analysis was based on the constant comparative method., Results: Participants' accounts comprised three key concerns: their experience of symptoms, the extent to which these impacted a variety of social roles and demands, and overcoming embarrassment. Accounts drew on individual circumstances, values, and concerns rather than objective or measurable criteria. In combination, these dimensions constituted a personal assessment of the severity of their UI and hence framed the extent to which women prioritized addressing their condition., Conclusions: Acknowledging women's personal accounts of UI shifts the concept of 'severity' beyond a medical definition to include what is important to patients themselves. Decision-making around elective surgery must endeavour to link medical information with women's own experiences and personal criteria, which often change in priority over time. We propose that this research provides insight into how the controversy around the use of mesh in the UK emerged. This study also suggests ways in which facilitating shared decision-making should be conducted in future.

Introduction: The aim of this study was to determine how recommendations of gynaecologists on surgical treatment for stress urinary incontinence (SUI) were influenced by patient characteristics., Methods: Two hundred forty-five gynaecologists in the UK fully responded to an online questionnaire including 18 vignettes describing 7 clinical characteristics of women with SUI (age, body mass index, SUI type, previous SUI surgery, frequency of leakage, bother, physical status). The gynaecologists scored recommendations for surgery ranging from 1 'certainly not' to 5 'certainly yes'. Mean scores were used to calculate the relative impact ('weight') of each clinical characteristic. Latent class analysis was used to distinguish groups of gynaecologists with a particular practice style because they responded to the patient characteristics captured in the case vignettes in a similar way., Results: The gynaecologists' overall average recommendation score was 2.9 (interquartile range 2 to 4). All patient characteristics significantly influenced the recommendation scores (p always < 0.001) but their impact was relatively small. SUI type was most important (weight 23%), followed by previous SUI surgery (weight 21%). Latent class analysis identified five groups of gynaecologists with practice styles that differed mainly with respect to their mean recommendation score, ranging from 1.3 to 4.0., Conclusions: Surgical treatment advice in response to case vignettes was only minimally influenced by patient characteristics. There were five groups of gynaecologists whose inclination to recommend surgical treatment varied. This suggests that there is lack of consensus on the role of surgery as a treatment for SUI. A considerable number of gynaecologists were reluctant to recommend surgery.

Pelvic mesh surgery has courted controversy with around 10% of patients experiencing complications. This article concentrates on the factors around pain, its presentation and management. Immediate pain is related to insertion and immediate removal recommended. With later presentation excision of the mesh relieves pain in up to 80% of women. Infection may be contributory but in refractory cases other factors maybe involved. Idiosyncratic reaction to mesh without risk factors appears to be relatively rare., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: Biomechanics of pelvic floor muscles is becoming an important field of research in understanding a complex process of labour. Current evidence indicates that the levator ani stretches to allow passage of the fetus through the birth canal. We sought to identify properties of the functional female pelvic floor during pregnancy that could help to predict the mode of delivery, especially in women who underwent caesarean section in the past., Methods: A single centre prospective cohort study of pregnant women in the 3rd trimester attending antenatal clinic. Participants were categorised into three groups: 1. nulliparous, 2. previous one vaginal delivery and 3. previous one caesarean section who chose a trial of labour in their current pregnancy. All women underwent ultrasonographic evaluation of their pelvic floor muscles. Distensibility and the mode of delivery were assessed in participants' current pregnancies. The primary outcome was the mode of delivery. ANOVA test was used for statistical analysis., Results: 133 women were included: 55 nulliparous, 52 primiparous (previous one vaginal birth), and 26 primiparous (previous one LSCS and planned for vaginal delivery after caesarean (VBAC)). Participants were scanned at an average gestation of 32 weeks. The inter-observer reliability test for puborectalis distensibility was good (kappa 0.75). Overall, women who delivered vaginally had a more distensible puborectalis muscle than those who delivered by emergency LSCS regardless of their previous type of delivery. Women who underwent a successful VBAC had less distensible pelvic floor muscles compared to their nulliparous and primiparous counterparts (who delivered vaginally in the past)., Conclusion: These results support our basic conceptual theory of puborectalis muscle distensibility influencing the mode of delivery and endorse application of dynamic pelvic floor ultrasound in future studies. We identified measurable differences in the functional female pelvic anatomy aiding a better understanding of physiology of the labour. There are trends towards lesser distensibility in women who delivered by LSCS., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Introduction and Hypothesis: Standardized measures enable the comparison of outcomes across providers and treatments giving valuable information for improving care quality and efficacy. The aim of this project was to define a minimum standard set of outcome measures and case-mix factors for evaluating the care of patients with overactive bladder (OAB)., Methods: The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group (WG) of leading clinicians and patients to engage in a structured method for developing a core outcome set. Consensus was determined by a modified Delphi process, and discussions were supported by both literature review and patient input., Results: The standard set measures outcomes of care for adults seeking treatment for OAB, excluding residents of long-term care facilities. The WG focused on treatment outcomes identified as most important key outcome domains to patients: symptom burden and bother, physical functioning, emotional health, impact of symptoms and treatment on quality of life, and success of treatment. Demographic information and case-mix factors that may affect these outcomes were also included., Conclusions: The standardized outcome set for evaluating clinical care is appropriate for use by all health providers caring for patients with OAB, regardless of specialty or geographic location, and provides key data for quality improvement activities and research.

Aims: Air filled catheters (AFCs) have been actively marketed for the past few years and in some geographic areas are widely used. However, as the scientific basis for introduction of this technology for pressure measurement in urodynamics was not clear, a study group examined the evidence., Methods: A search of the peer reviewed literature was carried out., Results: Four papers were identified, of which two were laboratory experiments and two were clinical papers, in female patients, that compared the pressures recorded by AFCs and those recorded using the traditional water filled catheters (WFCs). These data show that there are differences between the pressures measured by the two types of catheters. As yet, the reasons for these differences are not clear., Conclusions: There should be further systematic laboratory and clinical research before AFCs can be recommended for routine clinical use. We would recommend that a professional worldwide multidisciplinary scientific society, such as the International Continence Society, should work with manufacturers and regulatory bodies to ensure that this urodynamic method is properly scientifically evaluated, in the wider interests of patient safety., (© 2016 Wiley Periodicals, Inc.)

Introduction and Hypothesis: Retropubic tapes are successful for treating stress urinary incontinence (SUI), but there is controversy around risk profiles. The British Society of Urogynaecology (BSUG) database allows analysis of surgery for patient safety, surveillance and benchmarking. Objectives of this study were to establish success and complication rates in routine practice, determine complication rates for trainees and consultants, explore reasons for outliers and assess perforation as a surrogacy of quality., Methods: Approval was obtained from BSUG to use data on retropubic tapes. Data was anonymised, and patients gave prior consent. Analysis was done using the χ 2 test, and a funnel plot of bladder perforation rate was calculated., Results: There were 18,763 procedures recorded: 14,156 were performed by consultants, 64 by associate specialists (64), 1140 by subspecialty trainees, 2549 by registrars, 201 staff grades and 377 other. We found a 3.5 % bladder perforation rate, which was statistically higher for trainees than consultants (p < 0.05). The rate of other "standard" complications were low: 95.8 % of patients felt better on the Patient Global Impression of Improvement of Incontinence (PGI) scale. There was a significant difference (p < 0.05) in PGI and SUI outcome between patients who did and did not experience perforation., Conclusions: Success rates with retropubic tapes are high, with low complication rates. Bladder perforation in "real", not "trial" data was 3.5 %, which is lower than reported by the Cochrane review (4.5 %). Trainees have a higher perforation rate (p < 0.05) because of learning curves. Outliers are easily identified, and reasons for this should be explored, including proportion of trainees doing the surgery. This analysis confirms that bladder perforation is a valid surrogate for quality with a small but measurable difference. We have a responsibility to analyse data to improve patient care and encourage colleagues to support the International Urogynaecology Association (IUGA) database initiative.

Objective: Studies have demonstrated a strong positive correlation between bladder capacity and total volume voided in asymptomatic non-pregnant women. Therefore, to adequately characterise the normative data, it was important to compare bladder capacity vs. 24-h volume (V 24 ) relationships in our pregnant study population. Our objectives were to (1) collect normative bladder diary measurements from asymptomatic primigravid women, (2) investigate the relationship between these measurements and gestation of pregnancy, and (4) compare these normative measurements from pregnant women with those from asymptomatic non-pregnant women. We focused on measures of "bladder capacity" [average ("V avg ") and maximum volume per void ("V max ")], ("V 24 "), and voiding frequency ("F 24 ")., Study Design: Three-day bladder diaries were collected from 41 primigravid women, one three-day diary per trimester. We compared our pregnant data with non-pregnant data previously collected by Amundsen et al. using identical methods. Relationship between variables analysed using the Kruskal-Wallace and Mann-Whitney tests., Results: We found no significant differences across trimesters among bladder diary measurements (p-values: F 24 =0.711;V max =0.912;V avg =0.894, and V 24 =0.675). A comparison between pregnant and non-pregnant data showed no significant difference between F 24 , but a significantly lower V 24 , V avg and V max in pregnant women. Regression analysis showed no significant differences between the pregnant and non-pregnant, V 24 vs. bladder capacity relationships., Conclusions: Pregnancy results in smaller bladder capacities and lower V 24 , with a normal relationship between V 24 and bladder capacity, maintaining normal voiding frequency. We used our data to construct a nomogram to help clinicians compare the relative contributions of increased V 24 and reduced bladder capacity to increased F 24 ., (Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.)

Background: Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment., Methods: We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1-3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846., Findings: Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference -1·01, 95% CI -1·70 to -0·33; p=0·004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath)., Interpretation: Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies., Funding: Wellbeing of Women charity, the New Zealand Continence Association, and the Dean's Bequest Fund of Dunedin School of Medicine., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Introduction and Hypothesis: The objective of this article was to use the British Society of Urogynaecology (BSUG) database to assess the impact of age on success rates and insertion complications of suburethral tapes for primary procedures using the Patient Global Impression of Improvement (PGII) as the primary endpoint., Methods: We carried out a retrospective analysis of data at a national level (BSUG database) using PGII as the primary outcome measure. Secondary outcomes included improvement in stress incontinence and complications from surgery. All episodes of suburethral tapes on the database were extracted and analysis was by decade of life., Results: A total of 7,600 cases were identified on the database, of which 757 were in women over 70 years of age, with 119 in women over 80. Just over 80 % of the cases on the database involved retropubic and just under 20 % transobturator tapes. Short-term follow-up was available for 54 % of the cases. The PGII remained high in all age groups, but did decrease slightly with age, with more than 90 % of women under 50 scoring highly, which reduced to 70 % in those over 80. Improvement in stress incontinence was globally high, with 98 % scoring highly in the women aged under 50 and 85 % in the 80+ group. This suggests that the suburethral tapes worked well in treating stress incontinence. Reassuringly, complications did not increase with age, although short-term voiding difficulties were higher with increasing age., Conclusion: Contributing to national databases gives useful information that may be difficult to ascertain from RCTs. Suburethral tapes appear to have good efficacy and low complications with increasing age.

Introduction and Hypothesis: Lower urinary tract symptoms (LUTS) impact upon quality of life and occur in women of all ages. The National Institute for Clinical Excellence states that ambulatory urodynamic monitoring (AUM) should be used as a second-line investigational modality; however, its use is becoming more frequent. AUM provides a valid second line to conventional urodynamic methods that may be more widely used., Method: A literature review was undertaken to assess evidence for the use of AUM alongside a retrospective review of patients undergoing AUM at a tertiary care centre and symptom reporting at a follow-up visit. Both these methods included evidence for pathology detection, technical ease of use, recreation of symptoms and patient experience, allowing comparison of literature results to those experienced in day-to-day use., Results: The literature shows AUM to have sensitivity superior to that of other urodynamic investigations. However, evidence suggests this correlates less well with clinical effectiveness. Patients felt AUM was superior in recreating their symptoms, and they tolerated the procedure well. The increased technical demands of AUMs, however, meant that traces were more commonly harder to interpret than with conventional urodynamics. Our experience correlates well with the existing literature, suggesting increased symptom diagnosis; 63.2 % of diagnoses correlated well with symptoms., Conclusion: AUM remains an important urodynamic method to supplement conventional urodynamics. Evidence suggests it is superior in LUTS diagnosis, but its technical difficulty can affect results.

Introduction and Hypothesis: Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence., Methods: Submucosal injection of PAHG was performed in 135 women with urinary incontinence, with subjective and objective assessment of the efficacy and safety 24 months postinjection., Results: At 24 months, the subjective responder rate was 64 % (a statistically non-significant reduction from 67 % at 12 months). The decreased number of incontinence episodes and urine leakage were maintained compared with the result from the 12-month evaluations, as were objective result rates and quality of life data. No safety issues occurred., Conclusions: PAHG is an effective and safe treatment option for women with stress-predominant mixed urinary incontinence, with maintained medium-term responder rates.

Introduction and Hypothesis: Standardized terminology has yet to be developed for reporting the outcomes for surgery for pelvic organ prolapse (POP)., Methods: This report combines the input of the Terminology and Standardization Committees of the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a joint Working Group on this topic, as well as expert external referees. The aim was to present a standardized terminology for the definitions of surgery and propose a structure for reporting the outcomes of surgical procedures for POP. An extensive drafting and review process was undertaken, as well as open review on both IUGA and ICS websites., Results: A terminology report was developed outlining the recommended structure for reporting outcomes of surgical trials involving POP. This document does not define success and failure. The report includes patient-reported, subjective and objective outcomes to enable researchers to report on their results and compare them with other studies., Conclusions: A consensus-based method for standardizing terminology for reporting outcome measures of POP surgery was developed to aid clinicians working in this area of research.

Objective: To evaluate the effect of regional anesthesia and mode of delivery on the function of the urinary bladder. The primary outcome was the time taken for urinary bladder sensation to return following various modes of delivery and analgesia/anesthesia. The secondary outcome was the volume of urine present in the bladder when sensation returned., Methods: The study was conducted at the Birmingham Women's Foundation Trust, Birmingham, UK. A total of 120 postnatal patients were studied between January 2007 and March 2008. The volume of urine in the bladder when sensation first returned was measured by release of a clamp for women fitted with an indwelling catheter, and/or estimated using ultrasound., Results: The median times for sensation to return to the bladder in patients who had a vaginal delivery without epidural analgesia, vaginal delivery with epidural analgesia, and after elective cesarean delivery under spinal anesthesia were 122 minutes (IQR, 112-136 minutes), 234 minutes (IQR, 202-291 minutes), and 374 minutes (IQR, 311-425 minutes), respectively. The median urine volumes were 144 mL (IQR, 112-192 mL), 200 mL (IQR, 136-336 mL), and 152.5 mL (IQR, 125-270 mL), respectively., Conclusion: These results should be taken into consideration when formulating a postdelivery bladder care protocol., (Copyright 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Interstitial cystitis (IC) is a chronic inflammatory disorder of the bladder that is notoriously difficult to manage and can result in considerable morbidity. It very likely overlaps with painful bladder syndrome, but they are different conditions. The aetiology remains obscure, and the definition and diagnostic criteria are debated. The diagnosis of IC is one of exclusion, frequently based on symptoms and cystoscopy findings. Typical symptoms include frequency, urgency, dysuria and lower abdominal, bladder, vaginal, urethral or perineal pain, in the absence of bacterial cystitis. Voiding often relieves the suprapubic discomfort, and drinking alcohol- and caffeine-containing drinks frequently exacerbates it. Many treatments have been tried, with little sustained success. Proposed systemic treatments include anti-histamines, heparin, amitriptyline and pentosan polysulfate (a synthetic analogue of glycosaminoglycan which augments the mucous protective layer of the bladder). In many patients symptoms are improved following cysto-distension but the benefits are short-lived. Instillations of dimethyl sulfoxide, hyaluronic acid or chondroitin also show promise. Where treatments have failed and symptom severity is such that the patient's quality of life is poor, a urological opinion should be sought and reconstructive surgery considered. Available options include partial cystectomy, augmentation cystoplasty, and urinary diversion with or without cystectomy.

Objectives: To audit the clinical outcome of abdominal vault suspension (sacrocolpopexy, hysteropexy or cervicopexy) using non-absorbable mesh, without burial by closure of the peritoneum., Design: A case series., Setting: Urogynaecology units of four hospitals., Population: One hundred and twenty-eight women having open or laparoscopic sacrocolpopexy (121), hysteropexy (6) or cervicopexy (1) using non-absorbable mesh for vault prolapse., Methods: Patients had suspension of the vault, uterus or cervix from the sacral promontory using a monofilament polypropylene mesh. The pelvic peritoneum was not closed over the mesh. Patients were followed up every six months., Main Outcome Measures: Incidence of bowel complications as a consequence of the mesh; cure rate of prolapse and incidence of other post-operative complications; rate of re-operation for prolapse or incontinence., Result: After a median follow up of 19 months (1.5-62), there were no bowel complications as a result of non-burial of mesh. Three patients had asymptomatic vaginal mesh erosion, which required minor surgical intervention. Ninety percent of patients had good resolution of their prolapse symptoms while 10% of patients required further surgery., Conclusion: Leaving the mesh uncovered by the pelvic peritoneum was not associated with complications. It appears safe to perform vault suspension without closing the peritoneum.