BackgroundCurrent 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.MethodsWe 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.ResultsThe 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.ConclusionsWe 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.

Summary 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/m 2 vs ≥35 kg/m 2 ), 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 t...

Objective To compare the 'inside-out' versus 'outside-in' routes for transobturator tape insertion for urodynamic stress incontinence, and to identify independent risk factors for failure at 1 year.Design Prospective single-blinded randomised trial.Setting Tertiary urogynaecology centre. Methods Women were randomised to tension-free vaginal tape-obturator (TVT)-OÔ for the 'inside-out' route (n = 170) and transobturator tape (TOT)-ARISÒ for the 'outside-in' route (n = 171). Participants completed validated symptom-severity, quality-of-life and sexual-function questionnaires before and after surgery. In addition, they completed the patient global impression of improvement questionnaire (PGI-I) and standard 1-hour pad test postoperatively.Main outcome measures The primary outcome was the patientreported success rate reported on the PGI-I scale. Secondary outcomes included objective cure rate and improvement in King's Health Questionnaire scores.Results A total of 341 women were recruited: 171 women to the 'outside-in' (TOT-ARISÒ) group and 170 to the 'inside-out' (TVT-OÔ) group; 299 completed the 1-year follow up. The patient-reported success rate was 80% with no statistically significant differences between the groups ('outside-in' 77.6% versus 'inside-out' 81.2%; OR 1.25; 95% CI 0.71, 2.20; P = 0.54). The objective cure rate was 91% with no statistically significant difference between the groups ('outside-in' 88% versus 'insideout' 94%; OR 2.21; 95% CI 0.85, 5.75; P = 0.157). Previous incontinence surgery (OR 1.41; 95% CI 1.18, 1.91; P = 0.029) and preoperative urgency incontinence (OR 1.78; 95% CI 1.21, 3.91, P = 0.048) were significant risk factors for failure of transobturator tape at the 1-year follow up.Conclusions There are no significant differences in patient reported and objective cure rates between 'inside-out' and 'outside-in' transobturator tapes. Quality of life and sexual function significantly improved following surgery. Both previous incontinence surgery and preoperative urgency incontinence are associated with significantly lower patient-reported cure rates. Keywords ARISÒ , tension-free vaginal tapes, transobturator tape, TVT-OÔ, urodynamic stress incontinence.Please cite this paper as: Abdel-fattah M, Ramsay I, Pringle S, Hardwick C, Ali H, Young D, Mostafa A. Randomised prospective single-blinded study comparing 'inside-out' versus 'outside-in' transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study.

choice of tape was primarily decided by the surgeons' preference. RESULTSIn 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. CONCLUSIONThere were significantly more vaginal tape erosions in the Obtape group than in the TVT-O group. No cases of urethral erosions were identified.

Objectives To identify the rate of, and risk factors for, lower urinary tract (LUT) injuries associated with the transobturator tension-free vaginal tape (TOT) procedure.Design Retrospective cohort study.Setting Tertiary referral urogynaecology centre.Population 390 women who underwent transobturator suburethral tapes for management of urodynamic stress incontinence between July 2002 and January 2006.Methods Early cases were identified from theatre records and a case note review performed. From May 2005 (n = 94), data from an ongoing prospective audit were reviewed. Data for LUT injuries with TOT procedures were examined and routes of insertion were compared using Fischer's exact test.Main outcome measures Rate of LUT injuries associated with the TOT procedures. Assessment of factors increasing risk of LUT injury, and comparison of the 'outside-in' and 'inside-out' techniques.Results 241 women underwent TOT outside-in technique and 148 of them underwent inside-out technique. Four LUT injuries occurred (1%): two urethral injuries (0.5%) and two bladder injuries (0.5%). All LUT injuries occurred in the outside-in group, although this difference did not reach significance (P = 0.146). Bladder injuries occurred in women who underwent concomitant vaginal surgery, while urethral injuries occurred in women undergoing secondary procedures.Conclusion LUT injury is an uncommon complication of the TOT procedures, and in our hands only occurred with the outside-in technique. Intraoperative cystoscopy should be considered only in selected cases.Keywords Bladder injuries, lower urinary tract injury, transobturator tension-free vaginal tapes, urethral injuries, urodynamic stress incontinence.Please cite this paper as: Abdel-Fattah M, Ramsay I, Pringle S. Lower urinary tract injuries after transobturator tape insertion by different routes: a large retrospective study.

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A new approach to treating urodynamic stress incontinence (USI) is the transobturator tension-free vaginal tape (TOT). Inserting a suburethral tape at the mid-urethral level by the perineal route provides a minimally invasive means of reinforcing the structures that support the urethra. This approach, first described as the tension-free vaginal tape procedure, makes it unnecessary to gain blind entry into the retropubic space with the attendant risks of injuring the bladder, bowel, major blood vessels, or nerves.This retrospective cohort study was planned to determine the frequency of-and risk factors for-lower urinary tract (LUT) injuries in 389 women who, in the years 2002-2006, had a TOT procedure as treatment for USI at a tertiary referral urogynecology center. The outside-in technique was used in 241 cases, most often with Obtape®, while the remaining 148 women were operated on using the inside-out technique. In 70% of cases, the TOT procedure was primary surgery for USI. In 111 cases, another surgical procedure was carried out at the same time.Four LUT injuries were documented, 2 affecting the urethra and 2 the bladder. All 4 women had surgery using the outside-in technique, but this was not a statistically significant finding. Three of the 4 women with injuries underwent another procedure involving colporrhaphy. Both women with urethral injury underwent TOT surgery as a secondary procedure. In contrast, both those with bladder injuries were undergoing primary continence surgery. The overall incidence of LUT injury in this series was 1%.LUT injury is an infrequent complication of TOT procedures. In the present series of nearly 400 women, LUT injuries occurred only when using the outside-in technique. Intraoperative cystoscopy should be considered in selected cases only, but postoperative problems such as hematuria call for immediate cystoscopy. GYNECOLOGY Volume 62, Number 3 OBSTETRICAL AND GYNECOLOGICAL SURVEY ABSTRACTThe inability of colposcopy to reliably rule out cervical intraepithelial neoplasia (CIN) 2 or more advanced changes has complicated the management of women diagnosed colposcopically as having human papillomavirus (HPV) or CIN 1. This study assessed the risk of CIN 3 or cancer in a group of women given a colposcopic diagnosis of CIN 1 or less. The participants, with no past history of CIN, underwent colposcopy to evaluate abnormal cervical cytology in the form of atypical Office Gynecology 173 174 Obstetrical and Gynecological Survey Office Gynecology 175 176 Obstetrical and Gynecological Survey ABSTRACTMore than 10% of epithelial ovarian neoplasms are borderline ovarian tumors (BOTS), also known as ovarian tumors of low malignant potential. About one-fourth of them are found in potentially fertile women. Once thought to be a precursor of epithelial ovarian cancer, the BOT now is viewed as a biologically distinct entity. Five-year survival rates exceeding 95% are reported. Among 101 women operated on for BOT in the years 1992-2001 were 22 who had a fertility-preserving procedure in which at l...

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