Xing Xin1, Yue Song2, Zhijun Xia3. 1. Shengjing Hospital of China Medical University, Shenyang, 110004, China. ykxinxing@163.com. 2. Shengjing Hospital of China Medical University, Shenyang, 110004, China. songy@sj-hospital.org. 3. Shengjing Hospital of China Medical University, Shenyang, 110004, China. xiazjsci@163.com.
Abstract
PURPOSE: To compare the subjective and objective cure rates, postoperative pain, postoperative complications, and postoperative quality of life of adjustable single-incision sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the treatment of female stress urinary incontinence (SUI). METHODS:Female patients with SUI (N = 368) were randomized to receive either Ajust® (N = 184) or TVT-O™ procedure (N = 184) between January 2012 and October 2013. Efficacy was evaluated using cure rate, postoperative complications, postoperative pain profile (using Visual Analogue Scale), Patient Global Impression of Improvement Scale, and International Consultation on Incontinence Questionnaire-Short Form. RESULTS: The patients from Ajust® and TVT-O™ groups had no statistically significant difference in subjective and objective cure rates (94.4 vs 90.7 %, P = 0.171; 97.2 vs 90.7 %, P = 0.195). Compared with the TVT-O™ group, patients in the Ajust® group had significantly less postoperative pain, shorter operative duration, and less intraoperative blood loss (all P values < 0.05). No significant difference in perioperative complications was observed between these two groups. Patients in Ajust® group had shorter recovery time (P < 0.001) compared to TVT-O™ group. The postoperative quality of life of patients in these two groups was significantly improved compared to baseline; however, no significant difference was observed in the average improvement of life between these two groups (P = 0.115). CONCLUSIONS:Ajust® procedure is simple, safe, and effective for the treatment of SUI. Compared with TVT-O™, patients receiving Ajust® had less intraoperative blood loss, less postoperative pain, and shorter recovery time.
RCT Entities:
PURPOSE: To compare the subjective and objective cure rates, postoperative pain, postoperative complications, and postoperative quality of life of adjustable single-incision sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the treatment of female stress urinary incontinence (SUI). METHODS: Female patients with SUI (N = 368) were randomized to receive either Ajust® (N = 184) or TVT-O™ procedure (N = 184) between January 2012 and October 2013. Efficacy was evaluated using cure rate, postoperative complications, postoperative pain profile (using Visual Analogue Scale), Patient Global Impression of Improvement Scale, and International Consultation on Incontinence Questionnaire-Short Form. RESULTS: The patients from Ajust® and TVT-O™ groups had no statistically significant difference in subjective and objective cure rates (94.4 vs 90.7 %, P = 0.171; 97.2 vs 90.7 %, P = 0.195). Compared with the TVT-O™ group, patients in the Ajust® group had significantly less postoperative pain, shorter operative duration, and less intraoperative blood loss (all P values < 0.05). No significant difference in perioperative complications was observed between these two groups. Patients in Ajust® group had shorter recovery time (P < 0.001) compared to TVT-O™ group. The postoperative quality of life of patients in these two groups was significantly improved compared to baseline; however, no significant difference was observed in the average improvement of life between these two groups (P = 0.115). CONCLUSIONS: Ajust® procedure is simple, safe, and effective for the treatment of SUI. Compared with TVT-O™, patients receiving Ajust® had less intraoperative blood loss, less postoperative pain, and shorter recovery time.
Authors: Jordi Sabadell; Marta Palau-Gené; Eva Huguet; Anabel Montero-Armengol; Sabina Salicrú; Jose L Poza Journal: Int Urogynecol J Date: 2016-12-05 Impact factor: 2.894