Exploratory Study Assessing Efficacy and Complications of TVT-O, TVT-Secur, and Mini-Arc: Results at 12-Month Follow-Up

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• 作者：Rui Oliveira^a ; Francisco Botelho^a ; Pedro Silva^a ; Alexandre Resende^a ; Carlos Silva^a ; Paulo Dinis^a ; ^b ; Francisco Cruz^a ; ^b ; ^{cruzfjmr@med.up.pt"" rel=""nofollow}
• 关键词：Female stress urinary incontinence ; Midurethral sling ; Suburethral tape ; Mini-sling ; Single-incision sling ; TVT-O ; TVT-Secur ; Mini-Arc
• 刊名：European Urology
• 出版年：2011
• 出版时间：June 2011
• 年：2011
• 卷：59
• 期：6
• 页码：940-944
• 全文大小：231 K

文摘

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.