Effectiveness of intravaginal electrical stimulation combined with electromyography biofeedback-mediated pelvic floor muscle training for postpartum symptomatic pelvic organ prolapse: protocol for the PROSPECT randomized trial
机构:[1]Department of Obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dongdan, Dongcheng District, Beijing 100730, China.[2]Peking University Health Science Center, Beijing 100069, China.[3]Department of Obstetrics, the First People’s Hospital of Yunnan Province, Affiliated Hospital of Kunming University of Science and Technology, Kunming 650032, Yunnan, China.外科片产科云南省第一人民医院[4]Department of Obstetrics and Gynecology, Beijing Chaoyang Maternal and Child Health Hospital, Beijing 100026, China.[5]The Key Laboratory of Geriatrics, Beijing Institute of Geriatrics, Beijing Hospital, National Center of Gerontology, National Health Commission[6]Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100730, China.[7]Department of Obstetrics and Gynecology, Beijing Shunyi Traditional Chinese Medicine Hospital, Beijing 101300, China.
Background: Pelvic organ prolapse (POP) is seen in up to 30-70% of women presenting for routine gynecology care and 10% of women suffering from bothersome POP symptoms. Vaginal childbirth is one of the most prominent contributing factors for POP. Pelvic muscle training (PFMT) is considered effective to improve mild to moderate POP symptoms. In addition, higher-intensity, supervised PFMT aided by biofeedback and electrical stimulation may confer greater benefit. However, the long-term efficacy of the PFMT combined with electromyography biofeedback is unknown, which indicates the need for further evidence. Methods: This multicenter randomized controlled trial compares the effectiveness and cost-effectiveness of conventional PFMT versus biofeedback-mediated PFMT plus neuromuscular electrical stimulation (NMES) for postpartum symptomatic POP women. The primary outcome is the proportion of patients with the improvement of at least one POP-Q stage at 36 months after randomization. The primary economic outcome measure is incremental cost per quality-adjusted life year at 36 months. Two hundred seventy-four women from four outpatient medical centers are randomized and followed up with pelvic floor examination, questionnaires, and pelvic ultrasonography imaging. All participants are arranged for three appointments over 12 weeks. NMES and electromyography biofeedback via intravaginal probe are added to PFMT for participants in the biofeedback-mediated PFMT group. Group allocation could not be blinded from participants and healthcare staff that deliver intervention but remain masked from medical staff that carry out PFM assessment An intention-to-treat analysis of the primary outcome will estimate the difference of the proportion of POP-Q stage improvement between the trial groups right after the intervention, and during the follow-up until 36 months, using the chi-square test and multilevel mixed models respectively. A logistic regression analysis was used for adjusting for important baseline variables that are unbalanced. Discussion: The trial results will provide evidence of the effectiveness of electromyography biofeedback-mediated PFMT in improving women's POP-Q staging, quality of life, and cost-effectiveness.
基金:
Beijing Hospital Clinical Project 121 [BJ-2018-204]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81302277]; 2020 Kunming Medical University Joint Special Project on Applied Basic Research in Yunnan Province [202001AY070001-128]; 2019 Academicians and Experts Workstation in Yunnan Province [202005AF150033]
第一作者机构:[1]Department of Obstetrics and Gynecology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, No. 1 Dahua Road, Dongdan, Dongcheng District, Beijing 100730, China.
通讯作者:
推荐引用方式(GB/T 7714):
Min Li,Chunxue Yang,Qiubo Lv,et al.Effectiveness of intravaginal electrical stimulation combined with electromyography biofeedback-mediated pelvic floor muscle training for postpartum symptomatic pelvic organ prolapse: protocol for the PROSPECT randomized trial[J].TRIALS.2022,23(1):doi:10.1186/s13063-022-06051-z.
APA:
Min, Li,Chunxue, Yang,Qiubo, Lv,Xudong, Dong,Yan, Zhang...&Qing, Feng.(2022).Effectiveness of intravaginal electrical stimulation combined with electromyography biofeedback-mediated pelvic floor muscle training for postpartum symptomatic pelvic organ prolapse: protocol for the PROSPECT randomized trial.TRIALS,23,(1)
MLA:
Min, Li,et al."Effectiveness of intravaginal electrical stimulation combined with electromyography biofeedback-mediated pelvic floor muscle training for postpartum symptomatic pelvic organ prolapse: protocol for the PROSPECT randomized trial".TRIALS 23..1(2022)