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

• Type: Article in International Scientific Journal
• Date: 2011

Authors

Rui Oliveira (Author) Other; Francisco Botelho (Author) FMUP; Pedro Silva (Author) Other; Alexandre Resende (Author) Other; Carlos Silva (Author) FMUP; Paulo Oliveira (Author) FMUP; Francisco Cruz (Author) FMUP

Journal

Title: European Urology

Vol. 59 No. 6

Pages: 940-944

ISSN: 0302-2838

Publisher: Elsevier

Indexing

ISI Web of Knowledge - 57 Citations

Scopus - 71 Citations

Pubmed / Medline

Scientific classification

FOS: Medical and Health sciences > Clinical medicine

CORDIS: Health sciences > Medical sciences > Medicine > Urology

Other information

Authenticus ID: P-002-R8N

DOI: 10.1016/j.eururo.2011.01.018

Abstract (EN): 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.

Language: English

Type (Professor's evaluation): Scientific

No. of pages: 5