Beer Franziska, Kuppinger Madeleine, Schwab Frank, Hübner Markus, Kiefner Brenda, Nacke Anna, Kelkenberg Ute, Schütze Sabine, Lindner Anna, Hellmeyer Lars, Janni Wolfgang, Metz Melanie, Deniz Miriam
Department of Obstetrics and Gynecology, University Hospital of Ulm, Ulm, Germany.
Institute of Hygiene and Environmental Medicine, Charité Universitätsmedizin Berlin, Berlin, Germany.
Arch Gynecol Obstet. 2025 Apr;311(4):1209-1217. doi: 10.1007/s00404-024-07758-x. Epub 2024 Oct 10.
This study evaluates the restitution of pelvic floor function in postpartum women using the Restifem® pessary in a preventive and therapeutic approach.
In this multicentre study all postpartum women independently of their parity, mode of delivery and existing pelvic floor symptoms were offered to use the Restifem® pessary from 6 weeks postpartum for 3 to 6 months. They completed the validated German pelvic floor questionnaire (GPFQpp) via online survey at 6 weeks, 6 months and 12 months postpartum and were divided, by their own choice, into users and non-users of the pessary.
Initially 857 women were enrolled. After 6 weeks 137 pessary users and 133 non-users, after 12 months 53 pessary users and 45 non-users submitted a completed questionnaire. Pessary users had significantly higher (worse) scores in all domains of the GPFQpp at 6 weeks postpartum. At 12 months postpartum pessary users still had a significantly higher bladder score, compared to non-users. There was a greater improvement in the bladder score (p = 0.005) and the pelvic organ prolapse score (p < 0.001) from 6 weeks to 12 months postpartum, among pessary users compared to non-users.
Pessary users had a significantly greater improvement in pelvic floor function from 6 weeks to 12 months postpartum, compared to non-users. This effect might be in part due to wearing the pessary but also due to greater scope for recovery, given the higher level of pelvic floor dysfunction in the pessary user group.
The trial was registered in the German Clinical Trials Register (DRKS00024733) on 19 of April 2021.
本研究采用Restifem®子宫托，以预防和治疗的方式评估产后女性盆底功能的恢复情况。
在这项多中心研究中，所有产后女性，无论其胎次、分娩方式和现有的盆底症状如何，均被提供从产后6周开始使用Restifem®子宫托3至6个月。她们在产后6周、6个月和12个月通过在线调查完成了经过验证的德国盆底问卷（GPFQpp），并根据自己的选择分为子宫托使用者和非使用者。
最初招募了857名女性。6周后，137名子宫托使用者和133名非使用者提交了完整问卷；12个月后，53名子宫托使用者和45名非使用者提交了完整问卷。子宫托使用者在产后6周时，GPFQpp所有领域的得分显著更高（更差）。与非使用者相比，产后12个月时子宫托使用者的膀胱得分仍显著更高。与非使用者相比，子宫托使用者从产后6周到12个月，膀胱得分（p = 0.005）和盆腔器官脱垂得分（p < 0.001）有更大改善。
与非使用者相比，子宫托使用者在产后6周到12个月盆底功能有显著更大改善。这种效果可能部分归因于佩戴子宫托，但也归因于恢复空间更大，因为子宫托使用者组的盆底功能障碍水平更高。
该试验于2021年4月19日在德国临床试验注册中心（DRKS00024733）注册。
