Tension-Free Vaginal Tape Plus Intradetrusor BOTOX<superscript>®</superscript> Injection Versus Tension-Free Vaginal Tape Versus Intradetrusor BOTOX Injection in Equal-Weight Mixed Urinary Incontinence: A Prospective Randomized Study.

Objective: The aim of this study was to determine the safety of the placement of tension-free vaginal tape (TVT) plus intradetrusor BOTOX ® (onabotulinumtoxinA; Allergan, Inc., headquartered in Irvine, CA) injection, and the outcome after 12 months. Design: An open, prospective study was conducted on 93 patients presenting with stress and urgency urinary incontinence of the same severity from the patients' point of view. Materials and Methods : Subjects were divided into three groups: TVT+intradetrusor BOTOX injection (group 1); TVT only (group 2); or BOTOX injection only (group 3). At baseline, and at 1, 6, and 12 months, each patient was assessed by taking a medical history and performing a physical examination, including a cough test, a Q-Tip test, a 1-hour pad test, upper urinary tract sonography, postvoid residue, urinary analysis and culture, serum chemistry; and scores on the International Constellation on Incontinence Questionnaire (ICIQ)-Urinary Incontinence (UI), the ICIQ-Overactive Bladder (OAB), and the ICIQ-Quality of Life (QOL) instruments. Urodynamic studies, including filling cystometry, uroflowmetry, and abdominal leak-point pressure at baseline were performed. At a 1-month follow-up, cystometry and uroflowmetry were performed. Data were then analyzed using SPSS, Pearson's χ 2 , and Mann-Whitney U test. Results: The overall ICIQ-UI scores in group 1 declined from 15.4 to 2.5, 0, and 0, in 1, 6, and 12 months, respectively. In addition, ICIQ-OAB scores improved from an original mean baseline of 10.1 to 2.6, 0, and 1.1, in 1, 6, and 12 months, respectively. There was a significant improvement in urinary continence and, therefore, QOL for group 1 patients ( p<0.05). ICIQ-UI and ICIQ-OAB scores showed remarkable improvement in patients who underwent the sling procedure (group 2) and the BOTOX injection (group 3), respectively ( p<0.05). Nevertheless, the reverse did not occur. (There was insignificant change in ICIQ-OAB in group 2 and in ICIQ-UI in group 3). Retention occurred in 2, 0, and 2 patients in groups 1, 2, and 3, respectively, with no significant difference. Upper urinary-tract ultrasonography, urinary analysis and culture, and serum chemistry were normal in all patients. Conclusions: TVT plus intradetrusor BOTOX injection is a feasible and safe procedure. The results showed that there were subjects cured or with marked improvement at a 12-month follow-up. (J GYNECOL SURG 29:235) [ABSTRACT FROM AUTHOR]

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