Objectives To assess the complications and short‐term outcomes of prolapse repair mesh devices used in the management of female pelvic organ prolapse (POP). Design Retrospective cohort study. Setting Multicentre study involving a tertiary referral urogynaecology unit and two district general hospitals. Population 329 women who underwent surgical management of prolapse with various prolapse repair mesh devices in the period between January 2005 and December 2006. Methods Women were identified from theatre records. An independent clinician performed a case notes review during the period March to May 2007. Main Outcome Measures Complication rates and the short‐term cure at 3‐month follow‐up (defined as ≤stage I prolapse on the POP‐Q or Baden Walker scoring systems). Results A total of 289 women were included: 219 (76%) used the Gynecare prolapse repair mesh devices, while 70 women (24%) used the American Medical Systems prolapse repair mesh devices. Operative complications included: bladder injury (1.6%), rectal injury (1.1%) and two women with serious vascular injuries. Postoperative complications included: buttock pain (5.2%), vaginal erosion (10%), one woman with bladder erosion and two women (0.7%) with serious infection, leading to necrotising fasciitis in one woman. Short‐term cure rates in different groups varied from 94 to 100%, depending on vaginal compartment and device used. In total 15 women (5%) had persistent prolapse at 3‐month follow up. Conclusion The new prolapse repair mesh devices demonstrate excellent short‐term cure and low morbidity rates. However, some complications are serious and require highly specialised management. Rigorous evaluation by means of independent, controlled studies is urgently required.
Forty-seven women participated in a pilot study for a multi-centre randomized controlled trial of the effectiveness of pelvic floor muscle training (PFMT) for women with prolapse. Women with symptomatic stage I or II prolapse [measured by Pelvic Organ Prolapse Quantification (POP-Q)] were randomized to a 16-week physiotherapy intervention (PFMT and lifestyle advice; n = 23) or a control group receiving a lifestyle advice sheet (n = 24). Symptom severity and quality of life were measured via postal questionnaires. Blinded POP-Q was performed at baseline and follow-up. Intervention women had significantly greater improvement than controls in prolapse symptoms (mean score decrease 3.5 versus 0.1, p = 0.021), were significantly more likely to have an improved prolapse stage (45% versus 0%, p = 0.038) and were significantly more likely to say their prolapse was better (63% versus 24%, p = 0.012). The data support the feasibility of a substantive trial of PFMT for prolapse. A multi-centre trial is underway.
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.
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