A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence.

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.

Vaginal erbium laser treatment for stress urinary incontinence: A multicenter randomized sham-controlled clinical trial.

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.

Can we increase the value of data from bladder diaries? International Consultation on Incontinence-Research Society 2023.

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.

International urogynecological consultation chapter 4.1: definition of outcomes for pelvic organ prolapse surgery.

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.

Pelvic floor dysfunction and obesity.

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.

Anal incontinence following obstetric anal sphincter injury: Is there a difference between subtypes? A systematic review.

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.

Haemodynamic stability following adrenaline intracervical block for major haemorrhage during surgical management of late miscarriage: A case report.

The risk of heavy bleeding after a miscarriage is higher in women undergoing medical management compared with surgical. According to the literature, oxytocin receptor mRNA expression in the myometrium is not well formed during early gestation. Adrenaline may be considered in miscarriage which remains refractory to uterotonics and where bleeding from the placental bed may contribute to haemorrhage, before proceeding to surgical intervention. It is used in various settings to control bleeding in gynaecological procedures. A 34-year-old woman in her third pregnancy presented at 15 + 1 weeks of gestation with an open cervical os and bulging membrane. Within three hours of admission, she passed the fetus but failed to deliver the placenta and continued to bleed. She was taken to theatre for surgical management of miscarriage. The bleeding persisted following suction evacuation and despite the standard dose of oxytocin, and misoprostol uterotonics were given. Because the source of bleeding could be the placental bed, potentially low lying at this stage, a 4.4 ml prefix combination of 12.5 µg/ml adrenaline (1:80,000) and lidocaine (20 mg/ml) was administered as an intracervical block equally at four quadrants at the level of the cervical isthmus. This arrested the bleeding immediately and controlled the bleeding until discharge. This technique has not been described previously, which we believe causes vasoconstriction of the placental bed.

Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.

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.

Laser treatment for genitourinary syndrome of menopause: Scientific Impact Paper No. 72 (July 2022): Scientific Impact Paper No. 72 (July 2022).

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.

C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes-a multicentre randomised controlled trial.

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.

C-STICH2: emergency cervical cerclage to prevent miscarriage and preterm birth-study protocol for a randomised controlled trial.

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.

Feasibility study for the value of pelvic floor distension in predicting mode of birth for women undergoing Vaginal Birth After Caesarean.

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.

Minimum standards for reporting outcomes of surgery in urogynaecology.

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.

Defining nocturnal polyuria in women.

AIMS: Nocturnal polyuria (NP) is defined by the International Continence Society (ICS) as "excessive production of urine during the main sleep period" and is one of the main causes of nocturia. The ICS recognized that "excessive" is not clearly defined and that this needs to be highlighted in both clinical and research settings. The aim of this study was to identify different definitions of NP and apply them to a population of women attending the Urogynaecology clinic. METHODS: This was a retrospective study of complete bladder diaries collected from women attending a tertiary Urogynaecology Unit. Six different definitions were identified and were divided into "absolute," "relative," and "functional definitions." Prevalence data were calculated and values generated for sensitivity, specificity, positive and negative predictive values when related to women voiding ≥ 2 times per night. RESULTS: Complete bladder diaries were obtained from 1398 women, over 6 years, with a mean age of 57 years. Prevalence varied across the definitions from 21.5% (absolute definition) to 77% (relative definition). Sensitivity ranged from 43% (absolute) to 87% (relative). The definitions that showed the highest combined sensitivity and specificity were the functional definitions. CONCLUSION: From this study it is clear that more work needs to be done to arrive at a consensus for defining NP to enable accurate diagnosis and development of treatment pathways. We propose that a relative definition may provide a more clinically relevant method of defining NP.

Botulinum injections for myofascial pelvic pain.

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.

Making a decision about surgery for female urinary incontinence: a qualitative study of women's views.

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.

An analysis of 1386 periurethral bulking procedures with comparison to 18,763 retropubic tapes.

OBJECTIVE: To use British Society of Urogynaecology surgical database to evaluate periurethral bulking agents and retropubic tapes. STUDY DESIGN: Permission was granted to analyse 1386 periurethral bulking agents and 18,763 retropubic tapes. The primary outcome measure was patient reported global impression of improvement for incontinence with secondary outcomes of change in symptoms of stress incontinence, overactive bladder and complications. RESULTS: Patients undergoing periurethral bulking agents were older than retropubic tapes (mean 59.4 vs. 52.3 years). Urodynamic stress incontinence was the commonest urodynamic diagnosis (periurethral bulking agents 67%, retropubic tapes 77%) but there was a higher proportion of complex diagnoses in the periurethral bulking agents group. 59.2% patients reported 'very much/much better' on patient reported global impression of improvement for incontinence for periurethral bulking agents compared to 91% for retropubic tapes; 28% patients felt their symptoms of stress incontinence were cured following periurethral bulking agents compared to 77.6% for retropubic tapes and 0.8% developed de novo overactive bladder following periurethral bulking agents compared to 4% with retropubic tapes. There was no difference in outcomes when using periurethral bulking agents as a primary or secondary procedure. There were no intraoperative complications with periurethral bulking agents and fewer post-operative complications compared to retropubic tapes (3.6%). CONCLUSION: Patient reported success of periurethral bulking agents is lower than retropubic tapes but this is offset by minimal complications despite being an older, more complex patient group. Periurethral bulking agents do appear equally efficacious as a secondary procedure. Information derived from databases can be used during counselling to allow clinicians to demonstrate their own success and complication rates to ensure patients make an informed choice. Patient choice is paramount so all options should be included in full counselling.

Antibiotic resistance in urinary tract infections: A re-visit after five years and experience over two sites.

OBJECTIVE: The aim of this study was to repeat a previous audit, performed from 2009 to 2013, for the cohort of 2018 to determine how the resistance rates in urinary pathogens in women over 18 years of age have changed. A secondary aim of the study was to use resistance data from a different UK hospital in the same year to compare differences in resistance rates across different geographic locations. STUDY DESIGN: This was a retrospective study of all positive urine cultures grown from female patients attending two different hospitals in the year 2018. Resistance patterns were analysed. RESULTS: The resistance rate to co-amoxiclav continues to increase with amoxicillin retaining high resistance patterns. There are some significant differences in resistance patterns between the different locations. CONCLUSION: Antimicrobial resistance is a significant problem in the UK particularly in antibiotics used to treat UTI. These patterns can vary across different geographical locations and over time; therefore, up-to-date knowledge of local anti-biotic resistance is essential when making an appropriate prescription choice.