Zhixing Sun1, Lan Zhu, Tao Xu, Xinwen Shi, Jinghe Lang. 1. 1Department of Pediatrics 2Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China 3Department of Epidemiology and Statistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and School of Basic Medicine, Peking Union Medical College, Beijing, China.
Abstract
OBJECTIVE: The literature advocates preoperative vaginal estrogen (VE) therapy to reduce mesh exposure in pelvic organ prolapsed (POP); however, there are no comparative studies so far. This study aims to compare the effects of preoperative VE and non-VE therapy for the incidence of mesh exposure in postmenopausal women after transvaginal pelvic reconstructive surgery (PRS) with mesh. METHODS: A randomized noninferiority single-surgeon study of 186 women with severe POP was conducted. Ninety-three women (VE group) received0.5 g promestriene cream twice a week transvaginally for 6 weeks before PRS with mesh, and 93 women (non-VE group) underwent PRS with mesh 6 weeks after enrollment without pharmacologic preparation. The primary outcome was the occurrence of mesh exposure within 1 year. RESULTS: Overall, 173 of 186 participants (93.0%) completed 1-year follow-up. In an intention-to-treat analysis, the proportion of participants experiencing mesh exposure was 16.1% (15 of 93) in the VE group versus 12.9% (12 of 93) in the non-VE group (P = 0.024 for noninferiority). Both exposure area and time to exposure did not differ between the two groups. Similarly, no detectable differences at month 12 were found in terms of anatomic success, good response on the Patient Global Impression of Change, improvement in quality of life and sexual function, and complications. The result of per-protocol analysis agreed with that seen in the intention-to-treat analysis. CONCLUSIONS: In postmenopausal women with severe POP who underwenttransvaginal PRS with mesh, non-VE therapy before surgery was noninferior to VE therapy regarding mesh exposure rate within 1 year of follow-up.
RCT Entities:
OBJECTIVE: The literature advocates preoperative vaginal estrogen (VE) therapy to reduce mesh exposure in pelvic organ prolapsed (POP); however, there are no comparative studies so far. This study aims to compare the effects of preoperative VE and non-VE therapy for the incidence of mesh exposure in postmenopausal women after transvaginal pelvic reconstructive surgery (PRS) with mesh. METHODS: A randomized noninferiority single-surgeon study of 186 women with severe POP was conducted. Ninety-three women (VE group) received 0.5 g promestriene cream twice a week transvaginally for 6 weeks before PRS with mesh, and 93 women (non-VE group) underwent PRS with mesh 6 weeks after enrollment without pharmacologic preparation. The primary outcome was the occurrence of mesh exposure within 1 year. RESULTS: Overall, 173 of 186 participants (93.0%) completed 1-year follow-up. In an intention-to-treat analysis, the proportion of participants experiencing mesh exposure was 16.1% (15 of 93) in the VE group versus 12.9% (12 of 93) in the non-VE group (P = 0.024 for noninferiority). Both exposure area and time to exposure did not differ between the two groups. Similarly, no detectable differences at month 12 were found in terms of anatomic success, good response on the Patient Global Impression of Change, improvement in quality of life and sexual function, and complications. The result of per-protocol analysis agreed with that seen in the intention-to-treat analysis. CONCLUSIONS: In postmenopausal women with severe POP who underwent transvaginal PRS with mesh, non-VE therapy before surgery was noninferior to VE therapy regarding mesh exposure rate within 1 year of follow-up.