Total trans-obturator tape (TOT) removal; a case series including pain and urinary continence outcomes.

INTRODUCTION AND HYPOTHESIS: For many years, mid-urethral mesh tape (MUT) was the gold-standard procedure for management of stress urinary incontinence (SUI). However, significant concerns were raised over its safety. We present a case series of total trans-obturator tape (TOT) removals, performed in a tertiary unit over a 3-year period. We aim to evaluate improvement of pain and change in urinary continence symptoms following mesh explantation. METHODS: This is a retrospective case series of the outcomes of total TOT removal. Primary outcome is the change in pain scores following total removal, assessed preoperatively, at discharge and follow-up. Secondary outcomes were perioperative complications, including return to theatre, re-admission rates and incidence of worsening SUI and overactive bladder symptoms (OAB) postoperatively. Statistical analyses were performed using SPSS 27.0 package (IBM, Chicago, IL) and the GraphPad Prism 9 statistical packages. RESULTS: Nineteen women were identified. Mean age was 52 years and mean BMI was 31. Indications for mesh removal were: chronic pain (95%), vaginal exposure (37%) and pelvic sepsis (5%). No patients had return to theatre. Median intraoperative blood loss was 200 ml (interquartile range [IQR]: 150-288). Mean length of mesh excised was 22 cm. Mean postoperative hospital stay was 2 days. At follow-up, most patients (72%) reported "improvement" of their mesh-related pain at follow-up, while 6% reported "worsening" of pain. Eighty-three per cent of patients reported worsening SUI, and 50% reported worsening OAB symptoms. CONCLUSIONS: In the absence of sepsis, significant intraoperative complications are rare during total TOT removals. While 72% of patients reported improvement of their mesh-related pain, 6% still reported worsening pain after total mesh excision.

Should pregnant women know their individual risk of future pelvic floor dysfunction? A qualitative study.

BACKGROUND: The study aimed to explore: • pregnant women's and healthcare professionals' perspectives on provision of individual risk scores for future Pelvic Floor Dysfunction (PFD), • the feasibility of providing this during routine maternity care, • actions women might take as a result of knowing their PFD risk. METHODS: Qualitative study. SETTING: UK NHS Health Board. PARTICIPANTS: Pregnant women (n = 14), obstetricians (n = 6), midwives (n = 8) and physiotherapists (n = 3). A purposive sample of pregnant women and obstetric healthcare professionals were introduced to the UR-CHOICE calculator, which estimates a woman's PFD risk, and were shown examples of low, medium and high-risk women. Data were collected in 2019 by semi-structured interview and focus group and analysed using the Framework Approach. RESULTS: Women's PFD knowledge was limited, meaning they were unlikely to raise PFD risk with healthcare professionals. Women believed it was important to know their individual PFD risk and that knowledge would motivate them to undertake preventative activities. Healthcare professionals believed it was important to discuss PFD risk, however limited time and concerns over increased caesarean section rates prevented this in all but high-risk women or those that expressed concerns. CONCLUSION: Women want to know their PFD risk. As part of an intervention based within a pregnant woman/ maternity healthcare professional consultation, the UR-CHOICE calculator could support discussion to consider preventative PFD activities and to enable women to be more prepared should PFD occur. A randomised controlled trial is needed to test the effectiveness of an intervention which includes the UR-CHOICE calculator in reducing PFD.

Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: the MifeMiso RCT.

TRIAL DESIGN: A randomised, parallel-group, double-blind, placebo-controlled multicentre study with health economic and nested qualitative studies to determine if mifepristone (Mifegyne®, Exelgyn, Paris, France) plus misoprostol is superior to misoprostol alone for the resolution of missed miscarriage. METHODS: Women diagnosed with missed miscarriage in the first 14 weeks of pregnancy were randomly assigned (1 : 1 ratio) to receive 200 mg of oral mifepristone or matched placebo, followed by 800 µg of misoprostol 2 days later. A web-based randomisation system allocated the women to the two groups, with minimisation for age, body mass index, parity, gestational age, amount of bleeding and randomising centre. The primary outcome was failure to pass the gestational sac within 7 days after randomisation. The prespecified key secondary outcome was requirement for surgery to resolve the miscarriage. A within-trial cost-effectiveness study and a nested qualitative study were also conducted. Women who completed the trial protocol were purposively approached to take part in an interview to explore their satisfaction with and the acceptability of medical management of missed miscarriage. RESULTS: A total of 711 women, from 28 hospitals in the UK, were randomised to receive either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 out of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 out of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group (risk ratio 0.73, 95% confidence interval 0.54 to 0.98; p = 0.04). Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (risk ratio 0.70, 95% confidence interval 0.52 to 0.94; p = 0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A total of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview. Women appeared to have a preference for active management of their miscarriage. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The use of mifepristone and misoprostol showed an absolute effect difference of 6.6% (95% confidence interval 0.7% to 12.5%). The average cost per woman was lower in the mifepristone plus misoprostol group, with a cost saving of £182 (95% confidence interval £26 to £338). Therefore, the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. LIMITATIONS: The results from this trial are not generalisable to women diagnosed with incomplete miscarriage and the study does not allow for a comparison with expectant or surgical management of miscarriage. FUTURE WORK: Future work should use existing data to assess and rank the relative clinical effectiveness and safety profiles for all methods of management of miscarriage. CONCLUSIONS: Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again. The mifepristone and misoprostol intervention was shown to be cost-effective in comparison to misoprostol alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17405024. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 68. See the NIHR Journals Library website for further project information.

Miscarriage is a common complication of pregnancy, affecting approximately one in four women. Sometimes, medical treatment (i.e. tablets) may be offered to start or speed up the miscarriage process in order for the womb to empty itself. A drug called misoprostol (a tablet that makes the womb contract) is currently recommended for this treatment. However, the addition of another drug called mifepristone [a tablet that reduces pregnancy hormones (Mifegyne^®, Exelgyn, Paris, France)] might help the miscarriage to resolve more quickly. Therefore, we carried out the MifeMiso trial to test if mifepristone plus misoprostol is more effective than misoprostol alone in resolving miscarriage within 7 days. Women were randomly allocated by a computer to receive either mifepristone or placebo, followed by misoprostol 2 days later. Neither the women nor their health-care professionals knew which treatment they received. Some women also talked to the researchers about their experiences of taking part in the study. In total, 711 women were randomised to receive either mifepristone plus misoprostol or placebo plus misoprostol. Overall, 83% of women who received mifepristone plus misoprostol had miscarriage resolution within 7 days, compared with 76% of the women who received a placebo plus misoprostol. Surgery was required less often in women who received mifepristone plus misoprostol: 17% of women who received it required surgery, compared with 25% of women who received the placebo. Treatment with mifepristone did not appear to have any negative effects. Treatment with mifepristone plus misoprostol was more cost-effective than misoprostol alone, with an average saving of £182 per woman. Having taken part in the study, most women would choose medical management again and would recommend it to someone they knew who was experiencing a miscarriage.

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. METHODS: MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 µg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m2vs ≥35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024. FINDINGS: Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups. INTERPRETATION: Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Prospective observational study of the impact of vaginal surgery (pelvic organ prolapse with or without urinary incontinence) on female sexual function.

INTRODUCTION AND HYPOTHESIS: There is a difference of opinion in the literature as to whether pelvic organ prolapse (POP) is a direct cause of female sexual dysfunction (FSD). Sexual function in women is negatively impacted by the presence of urinary symptoms. Thus, sexual dysfunction (SD) might be improved, unchanged, or worsened by pelvic floor surgery. METHODS: In this study, we observed SD and impact of surgical intervention on female sexual function (FSF) using a validated Prolapse/Urinary Incontinence Sexual Questionnaire Short Form (PISQ-12) in women undergoing surgery for POP with or without urinary incontinence. Two hundred women were recruited and followed up at 6 and 12 months postoperatively. RESULTS: Sexual function (SF) as measured by the PISQ-12 improved after surgery irrespective of the nature of surgery or the patient's past gynaecology history. Improvement in SF was seen by 6 months (97 patients) postsurgery (P < 0.05), after which (at 12 months; 80 patients) no further change was observed. Improved SF was associated with better patient satisfaction postoperatively. CONCLUSIONS: Sexual function improved in women following surgery for POP with or withour urinary incontinence, irrespective of the nature of surgery and the patient's past gynecologic history. Results of this study will assist when counselling women with POP with or without urinary incontinence regarding treatment options.

A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse.

BACKGROUND: Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial. METHODS: We used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial. RESULTS: The feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices. CONCLUSIONS: We have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions.

Evaluation of transobturator tension-free vaginal tapes in management of women with recurrent stress urinary incontinence.

OBJECTIVES: To assess the efficacy of transobturator tapes in the treatment of women with recurrent urodynamic stress incontinence. METHODS: We performed a secondary analysis of a prospective, randomized, single-blinded study. A total of 341 women were recruited (April 2005 and April 2007) and randomly assigned to undergo "inside-out" TVT-O or "outside-in" TOT-ARIS. Of these women, 46 had undergone ≥1 previous continence procedures and were included in the present study. The preoperative assessment included a urodynamic assessment and completion of validated symptom severity and quality-of-life questionnaires. The primary outcome was the patient-reported success rate at 1 year as assessed using the Patient Global Impression of Improvement (very much/much improved). The secondary outcomes included changes in quality of life, sexual function, the objective success rates defined as negative findings on the standard 1-hour pad test, and a comparison between both routes of transobturator tapes. Multivariate analysis was performed to identify the risk factors for failure. RESULTS: All 46 women completed the 1-year follow-up period. The patient-reported success rate and objective cure rate was 69.6% and 76.5%, respectively, with no significant differences between the 2 transobturator routes (P = .104, odds ratio [OR] 2.933, 95% confidence interval [CI] 0.803-10.719; and P = .077, OR 4.524, 95% CI 0.849-24.109, respectively). Of the 46 women, 35 (76.1%) reported >10-point improvement on the total King's Health Questionnaire scores and 71% of sexually active women (n = 22) showed an improvement in the total 12-item Pelvic Organ Prolapse/Incontinence Sexual Function Questionnaire scores. On multivariate analysis, a maximal urethral closure pressure of <30 cm H(2)O was the only independent risk factor for failure (P = .016, OR 9.206, 95% CI 1.511-56.104). CONCLUSIONS: Transobturator tapes have good patient-reported and objective success rates at 1 year of follow-up in women with previous failed incontinence surgery. A low maximal urethral closure pressure was the only independent predictor of failure.

Evaluation of transobturator tapes (E-TOT) study: randomised prospective single-blinded study comparing inside-out vs. outside-in transobturator tapes in management of urodynamic stress incontinence: short term outcomes.

OBJECTIVES: To compare the "inside-out (TVT-O)" vs. "outside-in (ARIS)" transobturator tapes in the management of female urodynamic stress incontinence (USI) and to identify independent risk factors of failure of transobturator tapes. STUDY DESIGN: A prospective, single blinded, randomised trial. Women undergoing transobturator tapes as sole procedure in the period April 2005 and April 2007 were randomised to TVT-O for the inside-out approach and TOT-ARIS for the outside-in approach. The primary outcome measure at 6 months was the absence of USI on urodynamics. Secondary outcomes included; patient-reported success rates, overall patient satisfaction and peri-operative complications. RESULTS: 341 women were recruited: 171 in the outside-in group and 170 in the inside-out. Severe post-operative thigh pain was twice as common in the inside-out group but this was not statistically significant (6.7% vs. 3.5%, p=0.19). 317 women completed the 6 months follow-up; objective cure rates and patient-reported success rates were 85.4 and 80.5%, respectively, with no significant difference between the groups (p=0.28 and p=0.138, respectively). On multivariate analysis: low maximum urethral closure pressure (MUCP) (<30 cm H2O) and previous incontinence surgery were confirmed as independent risk factors for objective failure of transobturator tape with increased odds of failure of 7.06 (2.85-17.48) and 6.22 (2.34-16.52), respectively. CONCLUSION: This study shows no significant differences in the objective cure rates and patient-reported success rates between the "inside-out (TVT-O)" and "outside-in (ARIS)" transobturator tape procedures in the management of female USI at 6 months follow-up. Previous incontinence surgery and low MUCP were significant risk factors for failure of transobturator tapes.

How common are tape erosions? A comparison of two versions of the transobturator tension-free vaginal tape procedure.

OBJECTIVE: To compare two transobturator suburethral tapes (Obtape, Mentor-Porges and TVT-O, Gynaecare, Johnson and Johnson) used in the management of urodynamic stress incontinence (USI), for tape erosion (vaginal/urethral) rates, clinical presentation, management and outcome. PATIENTS AND METHODS: We retrospectively studied women who underwent a transobturator suburethral tension-free vaginal tape (TVT) procedure for managing USI in a tertiary referral centre in the West of Scotland over a 36-month period. In our department, the transobturator approach has been the first-choice approach for TVTs since July 2003. Two types of tapes were mainly used, Obtape and TVT-O, and the choice of tape was primarily decided by the surgeons' preference. RESULTS: In all, 316 women had a transobturator tape procedure, of which 96 were associated with another procedure; 112 women had TVT-O using the 'inside-out' technique and 204 had the 'outside-in' technique. Of the latter, 192 had Obtape, four had Obtryx (Boston Scientific) and eight had Monarc (American Medical Systems Inc.) tapes. Sixteen women developed vaginal tape erosion, and significantly more were in the Obtape group than in the TVT-O group (7.29% vs 1.78%, P = 0.038). The patients' age, body mass index, previous vaginal surgery and concomitant vaginal surgery were not significant risk factors for erosions. The time between surgery and diagnosis of erosion was 1-45 weeks, with only one patient being asymptomatic; all others presented with clinical symptoms such as vaginal bleeding, discharge and dyspareunia. Thirteen patients were continent at presentation and 10 of these remained continent after surgical management. In the TVT-O group the erosions were in the lateral vaginal wall, while in the Obtape group the erosions were in the form of central tape extrusion secondary to defective vaginal wall healing. CONCLUSION: There were significantly more vaginal tape erosions in the Obtape group than in the TVT-O group. No cases of urethral erosions were identified.