Willingness of postmenopausal women to participate in a study involving local vaginal oestrogen treatment as an adjunct to pelvic organ prolapse surgery: a qualitative study.

BACKGROUND: Pelvic organ prolapse (POP) negatively affects many women's quality of life. The ability to develop improved therapeutic approaches for POP patients is hampered by low patient recruitment and retention rates in clinical trials. OBJECTIVE: Our objective was to explore the motivational factors and barriers to recruitment and participation in clinical trials among postmenopausal women with POP who are intending to have surgical management. DESIGN: Qualitative study based on in-depth face-to-face interviews with postmenopausal women attending urogynaecology clinics in the UK intending to have surgical management for pelvic organ prolapse. These women were eligible to participate in the on-going clinical trial on the use of local vaginal oestrogen as an adjunct to surgical treatment. Twenty-two postmenopausal women aged 52-76 years were interviewed. Interviews were analysed using thematic analysis method. RESULTS: Many women participated because of altruistic motivations; however, we found that clarity of information provided, timing of approach and acceptability of study design played a pivotal role in women. Of the women who declined participation, the following themes emerged: uncertainty of the investigational product, fear of experimentation, logistical concerns and regret that their condition was trivialised at an early stage. CONCLUSION: We have gained a valuable insight into women's views and experience in the decision making process. Understanding the elements that will enhance trial participation such as clarity of information provided, balance between professional guidance whilst maintaining equipoise, easy access to trial teams and timing of approach will ultimately enable us to improve our recruitment to clinical trials.

Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial.

OBJECTIVE: To evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery. DESIGN AND SETTING: A randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015-August 2016). PARTICIPANTS: Postmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment. INTERVENTION: Women were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 µg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery. OUTCOME MEASURES: The main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial. RESULTS: 325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use. CONCLUSIONS: A large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation. TRIAL REGISTRATION NUMBER: ISRCTN46661996.

The impact of urodynamics on treatment and outcomes in women with an overactive bladder: a longitudinal prospective follow-up study.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to establish if the management of women with overactive bladder (OAB) and patient-reported outcomes differed based on the findings of urodynamics (UDS). METHODS: A prospective, longitudinal observational study conducted in urogynaecology clinics in 22 UK hospitals participating in the Diagnostic Accuracy of Bladder Ultrasound Study (BUS). A total of 687 women with OAB symptoms or urgency-predominant mixed urinary incontinence were recruited into a diagnostic study that used UDS as the reference standard. Detailed clinical history and International Consultation on Incontinence OAB Short Form (ICIQ-OAB sf) questionnaire responses were obtained before the UDS test was carried out. These questionnaires were subsequently collected at a mean of 7 and 20 months, along with patient global impression of improvement and details on medical and surgical treatments. The relationship between UDS diagnosis and treatment was examined using a multinomial regression model; logistic and repeated measures regressions were used to examine other outcomes. RESULTS: We recruited 687 women and the response rate was 69% at 20 months. Treatment subsequent to UDS was highly associated with diagnosis (p < 0.0001). Women who received treatment concordant with their UDS findings were more likely to report an improvement in bladder symptoms (57% vs 45%; p = 0.02) and ICIQ-OAB sf scores (0.5 points, 95%CI: 0.1 to 0.9; p = 0.02). CONCLUSIONS: Urodynamics influenced treatment decisions made by clinicians in determining treatment pathways in women presenting with OAB. Women treated based on UDS diagnoses appear to have greater reductions in symptoms than those who do not.

Obstetric anal sphincter injuries after episiotomy: systematic review and meta-analysis.

INTRODUCTION: There is conflicting evidence on whether mediolateral episiotomy (MLE) reduces the risk of obstetric anal sphincter injuries (OASI) in spontaneous vaginal deliveries (SVD). OBJECTIVES: A systematic review was undertaken to compare rates of OASI amongst women who had undergone mediolateral episiotomy versus those who did not. METHODS: ᅟ SEARCH STRATEGY: Electronic searches were performed in literature databases: CINAHL, Cochrane, EMBASE, Medline and MIDIRS from database inception to July 2015. Studies were eligible if MLE was compared to spontaneous tears and if OASI was the outcome of interest. Two reviewers independently selected and extracted data on study characteristics, quality and results. We computed events of OASI in those who did and did not have an episiotomy from individual studies and pooled these results in a meta-analysis where possible. MAIN RESULTS: Of the 2090 citations, 16 were included in the review. All were non-randomised, population based or retrospective cohort studies. There was great variation in quality amongst these studies. Data from 7 studies was used for meta-analysis. On collating data from these studies where the majority of women (636755/651114) were nulliparous, MLE reduced the risk of OASI (RR 0.67 95 % CI 0.49-0.92) in vaginal delivery. CONCLUSION: The pooled analysis of a large number of women undergoing vaginal birth, most of who were nulliparous, indicates that MLE has a beneficial effect in prevention of OASI. An accurately given MLE might have a role in reducing OASI and should not be withheld, especially in nulliparous women. Caution is advised as the data is from non-randomised studies.