Exploratory study assessing efficacy and complications of TVT-O, TVT-Secur, and Mini-Arc: results at 12-month follow-up.
نویسندگان
چکیده
BACKGROUND Contemporary surgical treatment of female stress urinary incontinence (SUI) includes retropubic and transobturator (TO) midurethral slings (MUS). Case series of single-incision slings (SIS) have shown similar outcomes with lower morbidity. OBJECTIVE Our aim was to assess the cure rates, complications, and quality-of-life impact of one standard TO MUS and two SIS. DESIGN, SETTING, AND PARTICIPANTS Ninety consecutive patients with clinically and urodynamically proven SUI were enrolled in an exploratory randomised phase 2 trial. Patients with previous SUI surgery, major pelvic organ prolapse, mixed incontinence, or detrusor overactivity were excluded. INTERVENTIONS Patients were treated randomly with TVT-O, TVT-Secur, or Mini-Arc. MEASUREMENTS Postoperative visits were scheduled at 6 and 12 mo. The King's Health Questionnaire (KHQ) was repeated at 6 mo. Cure was defined as the absence of urine leakage, no pad use, and a negative cough test at 12 mo. Pain and other complications were also investigated. RESULTS AND LIMITATIONS Cure rate was 83% after TVT-O, 67% after TVT-Secur, and 87% after Mini-Arc. Improvement was found in 10%, 13%, and 7% of the patients, respectively. Failures were 7% after TVT-O and Mini-Arc and 20% after TVT-Secur. TVT-O and Mini-Arc improved at least 15 points in >80% of the patients in six KHQ domains, whereas TVT-Secur could only achieve improvement in three of the nine domains. The pain score was lower in the Mini-Arc group. Complications were more numerous after TVT-O. This study has the limitations inherent in a phase 2 trial with a follow-up limited to 12 mo. CONCLUSIONS Mini-Arc offers cure and improvement rates similar to TVT-O, whereas TVT-Secur may yield an inferior outcome. These findings recommend the urgent launch of large randomised phase 3 studies comparing conventional MUS with SIS, with Mini-Arc the advised option.
منابع مشابه
Efficacy and Safety of Tension-Free Vaginal Tape-Secur Mini-Sling Versus Standard Midurethral Slings for Female Stress Urinary Incontinence: A Systematic Review and Meta-Analysis
PURPOSE To assess the efficacy and safety of tension-free vaginal tape (TVT)-Secur for stress urinary incontinence (SUI). METHODS A literature review was performed to identify all published trials of TVT-Secur. The search included the following databases: MEDLINE, Embase, and the Cochrane Controlled Trial Register. RESULTS Seventeen publications involving a total of 1,879 patients were used...
متن کاملEfficacy and Safety of the TVT-SECUR® and Impact on Quality of Life in Women with Stress Urinary Incontinence: A 2-Year Follow-Up
PURPOSE As recently reported, the short-term results of the tension-free vaginal tape SECUR® (TVT-S) procedure seem to be similar to those of the conventional transobturator tape (TOT) procedure. However, results of efficacy and satisfaction with TVT-S are insufficient in patients with more than 1 year of follow-up. Therefore, we evaluated the results of the TVT-S procedure in women with stress...
متن کامل[Our experience with mini tapes (TVT Secur and MiniArc) in the surgery for stress urinary incontinence].
BACKGROUND The purpose of this publication is to describe the surgical technique, assess complications and short-term results of TVT secur and MiniArc tapes. MATERIALS AND METHODS From October 2006 to August 2007 it was carried out the surgical correction with TVT Secur,Women's Health & Urology, Ethicon, Johnson & Johnson, placing the tape as a hammock, to 51 patients, 38 of them with pure st...
متن کاملSingle-incision mini-slings versus standard midurethral slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications.
CONTEXT An updated systematic review and meta-analysis of randomised controlled trials (RCTs) comparing single-incision mini-slings (SIMS) versus standard midurethral slings (SMUS) in the surgical management of female stress urinary incontinence (SUI). OBJECTIVE To evaluate the clinical efficacy, safety, and cost effectiveness of SIMS compared with SMUS in the treatment of female SUI. EVIDE...
متن کامل[Stress urinary incontinence surgical correction with third generation sub-mid-urethra sling: TVT-secur].
OBJECTIVE To review our initial experience with the new system TVT-Secur for the stress urinary incontinence. To evaluate the feasibility, efficacy and main advantages of the surgical correction with the new device. METHOD Between January and May of 2007, 16 TVT-Secur (Women's Health & Urology, Ethicon, Johnson & Johnson) were made in patients of the Urogynecology Unit, of Clinica Las Condes....
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ورودعنوان ژورنال:
- European urology
دوره 59 6 شماره
صفحات -
تاریخ انتشار 2011