Marzio Angelo Zullo1, Michele Carlo Schiavi2, Paolo Luffarelli1, Giovanni Prata3, Anna Di Pinto3, Cosimo Oliva4. 1. Department of Surgery-Week Surgery, Campus Biomedico, University of Rome, Rome, Italy. 2. Department of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome "Sapienza", Umberto I Hospital, Viale del Policlinico 155, 00161, Rome, Italy. michelecarlo.schiavi@gmail.com. 3. Department of Gynecological and Obstetric Sciences, and Urological Sciences, University of Rome "Sapienza", Umberto I Hospital, Viale del Policlinico 155, 00161, Rome, Italy. 4. Department of Gynecological and Obstetric, San Filippo Neri Hospital, Rome, Italy.
Abstract
INTRODUCTION: To compare the efficacy, safety and complications of the trans-obturator midurethral sling from inside to outside (TVT-O) and of the shorter trans-obturator midurethral sling (TVT-Abbrevo) for treatment of female SUI. MATERIALS AND METHODS:One hundred fifty-eight recruited patients were randomized into either the TVT-O or TVT-Abbrevo group. Preoperative assessment included history and general assessment, urinalysis and urine culture, urogynaecological clinical examination, urodynamic evaluation and urogynaecologic interview by ICIQ-SF-UI, PGI-I and PISQ12. Operative time, perioperative complications, spontaneous voiding, postoperative complications and hospital stay were prospectively recorded in all patients. At 3, 6, 12, 24 and 36 months after surgery, patients were asked to answer urogynaecological interviews by ICIQ-SF-UI, PGI-I and PISQ12. The urodynamic assessment was performed at 12, 24 and 36 months. Success rate was assessed at 12, 24 and 36 months postoperatively. RESULTS: Overall, 138 of 158 patients (87%) were cured of SUI 36 months after the operation with no significant differences between groups [69 (87%) and 69 (87%) patients in the TVT-O and TVT Abbrevo groups, respectively]. The two groups did not significantly differ in operative time, intraoperative blood loss and length of hospital stay. Nine patients (11%) had postoperative groin pain in the TVT-O group and one patient in the TVT Abbrevo group (p = 0.02). Three-year control demonstrated an equal objective cure rate in both groups. There was a significant improvement in total PISQ-12 and ICIQ-SF-UI scores in both groups at 36 months FU. CONCLUSION:TVT-Abbrevo has similar efficacy and safety compared with TVT-O in women with SUI; the use of a shorter sling reduces postoperative pain.
RCT Entities:
INTRODUCTION: To compare the efficacy, safety and complications of the trans-obturator midurethral sling from inside to outside (TVT-O) and of the shorter trans-obturator midurethral sling (TVT-Abbrevo) for treatment of female SUI. MATERIALS AND METHODS: One hundred fifty-eight recruited patients were randomized into either the TVT-O or TVT-Abbrevo group. Preoperative assessment included history and general assessment, urinalysis and urine culture, urogynaecological clinical examination, urodynamic evaluation and urogynaecologic interview by ICIQ-SF-UI, PGI-I and PISQ12. Operative time, perioperative complications, spontaneous voiding, postoperative complications and hospital stay were prospectively recorded in all patients. At 3, 6, 12, 24 and 36 months after surgery, patients were asked to answer urogynaecological interviews by ICIQ-SF-UI, PGI-I and PISQ12. The urodynamic assessment was performed at 12, 24 and 36 months. Success rate was assessed at 12, 24 and 36 months postoperatively. RESULTS: Overall, 138 of 158 patients (87%) were cured of SUI 36 months after the operation with no significant differences between groups [69 (87%) and 69 (87%) patients in the TVT-O and TVT Abbrevo groups, respectively]. The two groups did not significantly differ in operative time, intraoperative blood loss and length of hospital stay. Nine patients (11%) had postoperative groin pain in the TVT-O group and one patient in the TVT Abbrevo group (p = 0.02). Three-year control demonstrated an equal objective cure rate in both groups. There was a significant improvement in total PISQ-12 and ICIQ-SF-UI scores in both groups at 36 months FU. CONCLUSION:TVT-Abbrevo has similar efficacy and safety compared with TVT-O in women with SUI; the use of a shorter sling reduces postoperative pain.