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.
RCT Entities:
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.
Authors: Jaromir Masata; Kamil Svabik; Karel Zvara; Petra Drahoradova; Rachid El Haddad; Petr Hubka; Alois Martan Journal: Int Urogynecol J Date: 2012-10 Impact factor: 2.894
Authors: Gert Naumann; Thomas Hagemeier; Stefan Zachmann; Aktham Al-Ani; Stefan Albrich; Christine Skala; Rosa Laterza; Misti Linaberry; Heinz Koelbl Journal: Int Urogynecol J Date: 2012-06-16 Impact factor: 2.894
Authors: Annetta M Madsen; Sherif A El-Nashar; Joshua L Woelk; Christopher J Klingele; John B Gebhart; Emanuel C Trabuco Journal: Int Urogynecol J Date: 2013-09-17 Impact factor: 2.894