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Objective To compare the pubovaginal sling and transurethral Macroplastique in the treatment of female stress urinary incontinence (SUI) and intrinsic sphincter deficiency (ISD). Design A prospective randomised controlled trial comparing two surgical treatments for SUI and ISD.Setting Tertiary referral urogynaecology unit in Australia.Population Women with SUI and ISD who were suitable for either surgical technique.Methods Forty-five women with SUI and ISD were randomly allocated the pubovaginal sling (n ¼ 22) or transurethral Macroplastique (n ¼ 23). Subjective and objective success rates, patient satisfaction and cost measurements at six months and one year following surgery were the primary outcome measures. A telephone questionnaire survey was performed at a mean follow up period of 62 months (43 -71). Main outcome measure Comparison of success rates, complications and costs.Results The symptomatic and patient satisfaction success rates were similar following the sling and Macroplastique with the objective success rate being significantly greater (P < 0.001) following the sling (81% vs 9%). Macroplastique had significantly lower morbidity but was more expensive than the sling (P < 0.001). Response rate at 62 months follow up was 60% in both groups with the sling group reporting better continence success (69% vs 21%) and satisfaction rates (69% vs 29%, P ¼ 0.057). Conclusions The pubovaginal sling was more effective and economical than transurethral Macroplastique for the treatment of SUI and ISD. However, transurethral Macroplastique remains an appropriate treatment in selected cases of SUI and ISD.

ObjectiveTo compare vaginal repair augmented by mesh with traditional colporrhaphy for the treatment of pelvic organ prolapse.DesignProspective randomised controlled trial.SettingTertiary teaching hospital.PopulationOne hundred and thirty-nine women with stage ≥2 prolapse according to the pelvic organ prolapse quantification (POP-Q) system requiring both anterior and posterior compartment repair.MethodsSubjects were randomised to anterior and posterior vaginal repair with mesh augmentation (mesh group, n= 69) or traditional anterior and posterior colporrhaphy (no mesh group, n= 70).Main outcome measuresThe primary outcome was the absence of POP-Q stage ≥2 prolapse at 12 months. Secondary outcomes were symptoms, quality-of-life outcomes and satisfaction with surgery. Complications were also reported.ResultsFor subjects attending the 12-month review, success in the mesh group was 81.0% (51 of 63 subjects) compared with 65.6% (40/61) in the no mesh group and was not significantly different (P-value = 0.07). A high level of satisfaction with surgery and improvements in symptoms and quality-of-life data were observed at 12 months compared to baseline in both groups, but there was no significant difference in these outcomes between the two groups. Vaginal mesh exposure occurred in four women in the mesh group (5.6%). De novo dyspareunia was reported by five of 30 (16.7%) sexually active women in the mesh group and five of 33 (15.2%) in the no mesh group at 12 months.ConclusionIn this study, vaginal surgery augmented by mesh did not result in significantly less recurrent prolapse than traditional colporrhaphy 12 months following surgery.

Objective To compare perioperative characteristics, short-term, and long-term outcomes for laparoscopic Burch colposuspension (LBC) and open Burch colposuspension (OBC) for the treatment of urinary stress incontinence.Design Randomised surgical trial with single blinding.Setting Three tertiary level teaching hospitals involving seven surgeons of varying skill levels.Population Two hundred women with urodynamic stress incontinence (USI).Methods The two groups were treated in identical fashion, except for the laparoscopic or open approach to surgery. Attempts were made to blind the subjects and the observers obtaining outcome data to treatment group. Analyses were adjusted for surgeon experience.Main outcome measures Absence of USI 6 months following surgery, postoperative pain, time spent in hospital, and time to return to activities of normal daily living.Results There were no significant differences in objective and subjective measures of cure and in patient satisfaction at 6 months, 24 months, or 3-5 years of follow up between laparoscopic and open colposuspension groups. Laparoscopic colposuspension took longer time to perform (87 versus 42 minutes, P < 0.0001) but was associated with less blood loss (P = 0.03), less pain (P = 0.02), and quicker return to normal activities (P = 0.01).Conclusion LBC has significant advantages over traditional OBC, without any apparent compromise in short-term and long-term outcomes.

Objectives To objectively assess the success rate at 6 months after tension-free vaginal tape obturator (TVT-O) procedure. To assess subjective success rates, complications, patient satisfaction, and quality of life (QOL).Design A prospective observational study.Setting A tertiary referral urogynaecology practice. Methods The TVT-O technique was performed as described. Three standardised QOL questionnaires were completed preoperatively at 6 months and 12 months. At 6 months, a urogenital history, visual analogue scale score (VAS) for patient satisfaction, uroflow, and urinary stress test were performed. After 12 months, a urogenital history and patient satisfaction verbal analogue score (VeAS) were obtained by telephone interview.Main outcome measure Objective success rate of the TVT-O procedure was measured by negative stress test. Secondary outcomes were subjective success rates at 6 and 12 months, pre-and postoperative comparison of urodynamic parameters, complications, postoperative symptomatology, QOL analysis, and patient satisfaction.Results Mean follow up was 18.5 months. Objective success rate was 95%. Subjective success rates were 92 and 84% at 6 and 12 months. Complications included recurrent urinary tract infection (six), voiding difficulty (two), persistent groin discomfort (three), haematoma (one), wound infection (one), vaginal tape erosion (one), and urethral irritation (one). Prevalence of de novo urge incontinence was 4.1 and 4.8% at 6 and 12 months. QOL analysis showed significant improvements in QOL scores postoperatively. Visual and verbal analogue scores indicated high patient satisfaction (VAS, VeAS ‡ 80%) in 77 and 67% at 6 and 12 months.Conclusion The TVT-O is a safe and effective treatment for female stress urinary incontinence.

Objectives To describe a new surgical procedure for pelvic organ prolapse using mesh and a vaginal support device (VSD) and to report the results of surgery.Design A prospective observational study.Setting Two tertiary referral Urogynaecology practices.Population Ninety-five women with International Continence Society pelvic organ prolapse quantification stage 2 or more pelvic organ prolapse who underwent vaginal surgery using mesh augmentation and a VSD.Methods Surgery involved a vaginal approach with mesh reinforcement and placement of a VSD for 4 weeks. At 6 and 12 months, women were examined for prolapse recurrence, and visual analogue scales for satisfaction were completed. Women completed quality-of-life (QOL) questionnaires preoperatively and at 6 and 12 months.Main outcome measures Objective success of surgery at 6 and 12 months following surgery. Secondary outcomes were subjective success, complications, QOL outcomes and patients' satisfaction.Results Objective success rate was 92 and 85% at 6 and 12 months, respectively. Subjective success rate was 91 and 87% at 6 and 12 months, respectively. New prolapse in nonrepaired compartments accounted for 7 of 12 (58%) failures at 12 months. Two of 4 mesh exposures required surgery. Sexual dysfunction was reported by 58% of sexually active women preoperatively and 23% at 12 months. QOL scores significantly improved at 12 months compared with baseline (P < 0.0001). ConclusionVaginal surgery using mesh and a VSD is an effective procedure for pelvic organ prolapse. However, further studies are required to establish the role of the surgery described in this study.Keywords Mesh, prolapse, vaginal support device.Please cite this paper as: Carey M, Slack M, Higgs P, Wynn-Williams M, Cornish A. Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device. BJOG 2008;115:391-397.

The use of synthetic mesh to augment vaginal repair procedures for pelvic organ prolapse has increased in large part because of dissatisfaction with the success rates of traditional colporrhaphy. Its use, however, is controversial. Four randomized controlled studies comparing traditional colporrhaphy with vaginal repair using mesh augmentation had conflicting results. This unblinded, prospective, randomized controlled trial investigated whether mesh augmentation during vaginal repair would reduce the rate of recurrent prolapse at 12 months compared with traditional colporrhaphy. A total of 139 women with stage 2 or more prolapse who required both anterior and posterior compartment repair were randomized to mesh augmentation (mesh group, n ϭ 69) or colporrhaphy (no mesh group, n ϭ 70). Study subjects were enrolled between 2003 and 2005 at a tertiary teaching hospital. Prolapse was staged using the pelvic-organ-prolapse quantification (POP-Q) system. The primary study outcome was objective success of surgery defined as the absence of POP-Q stage 2 or more prolapse at 12 months following surgery. Questionnaires were used to assess secondary outcomes including symptoms, quality of life, and patient satisfaction.Of the 139 women, 63 of 69 (93.1%) in the mesh group and 61 of 70 (87.1%) in the no mesh group attended the 12-month follow-up. There was no significant difference at 12 months in objective success (POP-Q stage 0 or 1) between the mesh and no mesh groups (mesh: 81.0% ͓51/63͔ vs. no mesh: 65.6% ͓40/61͔; P ϭ 0.07). Although patients in both groups expressed a high level of satisfaction with the surgery and improved symptoms and parameters of quality of life compared to baseline, there was no statistically significant difference in these outcomes between the 2 groups (P ϭ ns). Postoperative complications in the mesh group included four cases (5.6%) of vaginal mesh exposure. At 12 months, de novo dyspareunia was reported in 27.8% (5/18) of the sexually active women without preoperative dyspareunia in the mesh group and in 41.7% (5/12) of those in the no mesh group. These differences were not significant (P ϭ 0.46).These findings show that anterior and posterior vaginal repair with mesh augmentation at 12 months after surgery does not result in significantly less recurrent prolapse than traditional colporrhaphy.

On the basis of this limited study, we are hesitant to recommend the 'U' configuration of the TVT-Secur over its more established counterparts, the TVT and TVT-O.