Tension-free vaginal tape-O and -Secur for the treatment of stress urinary incontinence: a thirty-six-month follow-up single-blind, double-arm, randomized study.
OBJECTIVE
To compare the efficacy of the inside-out tension-free vaginal tape-obturator (TVT-O) device versus the single-incision TVT-Secur device 36 months after the procedure.


METHODS
A single-blind, randomized, parallel-group study on 154 patients with stress urinary incontinence (77 treated with TVT-O and 77 with the TVT-Secur hammock approach). The primary endpoint was the objective cure rate 36 months after the procedure evaluated with the challenge stress test. Secondary endpoints were subjective cure rate (evaluated with bladder diary, quality-of-life questionnaires, and patient-reported outcome tools) and intraoperative and postoperative complications. The primary endpoint was evaluated with a noninferiority study design.


RESULTS
Sixty-six patients in the TVT-O group and 64 in the TVT-Secur group concluded the study. Thirty-six months after the procedure, 57/66 patients (86.4%) in the TVT-O and 50/64 (78.1%) in the TVT-Secur groups were objectively cured (noninferiority unilateral u test: p < .05). No differences were observed in the subjective cure and complication rates.


CONCLUSIONS
TVT-Secur seems not to be inferior to TVT-O in the surgical treatment of stress urinary incontinence and causes less postoperative pain. The possibility of severe blood loss cannot be ruled out when TVT-Secur is used.
Department of Obstetrics and Gynecology - University of Naples "Federico II", Naples, Italy. gtommaselli@yahoo.it
Giovanni A
GA
Tommaselli
Alessandro
A
D'Afiero
Costantino
C
Di Carlo
Carmen
C
Formisano
Annamaria
A
Fabozzi
Carmine
C
Nappi
D000368:Aged; D016063:Blood Loss, Surgical; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D010149:Postoperative Pain / Q000209:etiology; D011788:Quality of Life; D016037:Single-Blind Method; D053825:Suburethral Slings / Q000009:adverse effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*