Group-based PFMT programme for preventing and/or treating UI in pregnant women: protocol of a randomized controlled feasibility study

Abstract

Abstract Background Urinary incontinence (UI) is a prevalent health problem in women worldwide. Many women experience UI during pregnancy. The National Institute for Health and Care Excellence (NICE) recommended pelvic floor muscle training (PFMT) as the first-line conservative treatment for UI. However, it is not widely implemented due to the limited number of healthcare trainers. Group-based PFMT has been used with older women and a limited number of maternity studies. But the effectiveness of the group-based PFMT needs to be investigated because the overall quality of the studies is low. Therefore, this study aims to assess the feasibility of delivering a group-based PFMT programme for pregnant women in Nanjing city. Methods This feasibility study will be conducted in Nanjing Maternity and Child Health Care Hospital in China, using a mixed methods design to investigate the feasibility and acceptability of delivering group-based PFMT to pregnant women. Pregnant women with or without the symptoms of UI will be included. This study aims to recruit 48 pregnant women with 24 in each arm. Participants will receive either the group-based PFMT delivered by a midwife or usual antenatal care which includes only verbal instruction on PFMT. The study will assess the completion rates, acceptability of outcome measures, recruitment and retention rate and calculate an appropriate sample size for a future study. Discussion The results of this study will inform the design and implementation of a definitive randomized clinical trial to explore the effectiveness of the intervention. Trial registration ClinicalTrials.gov, NCT05242809.