International journal of environmental research and public health · 2021
Effect of the App-Based Video Guidance on Prenatal Pelvic Floor Muscle Training Combined with Global Postural Re-education for Stress Urinary Incontinence Prevention: A Protocol for a Multicenter, Randomized Controlled Trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Gao Lei, Zhang Di, Wang Shiyan, Jia Yuanyuan, Wang Haibo, Sun Xiuli, Wang Jianliu
Аннотация
BACKGROUND: As the effectiveness on stress urinary incontinence (SUI) prevention of pelvic floor muscle training (PFMT) for pregnant women has been inconclusive, we are planning to conduct a trial to evaluate a video program designed for prevention of SUI developed through combining PFMT with global postural reeducation (GPR).
METHODS: As a randomized controlled trial, eligible participants will be randomized (1:1) into an exercise group and a control group to perform PFMT regularly following video guidance or with no intervention, respectively. The experimental stage will be from the 16th gestation week (GW) to the 12th month postpartum, with eight appointments at the 16th, 28th, 37th GW, delivery, the 6th week and the 3rd, 6th, and 12th month postpartum. Data will be collected regarding urinary leakage symptoms, the stress test, the modified Oxford Scale, pelvic floor ultrasound, perineal laceration classification at delivery, neonatal Apgar score, and questionnaires (PISQ-12, ICIQ-UI SF, I-QOL, OABSS). The primary outcome is the occurrence of the symptomatic SUI and positive stress test at the 6th week postpartum.
DISCUSSION: This protocol is anticipated to evaluate the efficacy of the intervention via video app for the design of a future randomized control trial (RCT).
TRIAL REGISTRATION: The trial has been registered at Chinese Clinical Trial Registry (registration number: ChiCTR2000029618).
METHODS: As a randomized controlled trial, eligible participants will be randomized (1:1) into an exercise group and a control group to perform PFMT regularly following video guidance or with no intervention, respectively. The experimental stage will be from the 16th gestation week (GW) to the 12th month postpartum, with eight appointments at the 16th, 28th, 37th GW, delivery, the 6th week and the 3rd, 6th, and 12th month postpartum. Data will be collected regarding urinary leakage symptoms, the stress test, the modified Oxford Scale, pelvic floor ultrasound, perineal laceration classification at delivery, neonatal Apgar score, and questionnaires (PISQ-12, ICIQ-UI SF, I-QOL, OABSS). The primary outcome is the occurrence of the symptomatic SUI and positive stress test at the 6th week postpartum.
DISCUSSION: This protocol is anticipated to evaluate the efficacy of the intervention via video app for the design of a future randomized control trial (RCT).
TRIAL REGISTRATION: The trial has been registered at Chinese Clinical Trial Registry (registration number: ChiCTR2000029618).