Abstract
BackgroundA future cluster randomised controlled trial (cRCT) to test an intervention to prevent postpartum urinary incontinence will use a postal questionnaire from women to obtain outcomes. This is part of a programme of work that has the overall aim of reducing the proportion of women with urinary incontinence after birth. One part of the programme was a methodology trial to compare a longer questionnaire, which includes all outcomes, with a shorter questionnaire, which includes only the most important outcomes, in order to maximise women’s response to these sensitive questions. MethodsA multicentre, stratified by community midwife team, with balanced randomisation [1:1] controlled, parallel group trial was undertaken including women under the care of 15 community midwife teams in three West Midlands NHS trusts who had given birth 10-12 weeks previously. Women under 16 years and women without a live baby on hospital discharge were excluded. Eligible women under the care of each midwife team were individually randomised in a 1:1 ratio to receive either a long or short questionnaire. Both questionnaires included questions on urinary and bowel incontinence and about advice and information on pelvic floor muscle exercise (PFME) and their PFME practice. The long questionnaire included additional questions about women’s confidence in undertaking pelvic floor muscle exercise (PFME) and their general health. For women randomised to the short questionnaire, the additional questions were only sent to women who returned the first questionnaire. The primary outcome of this trial was the response rate for completion of the urinary incontinence (UI) questions. Secondary outcomes were urinary incontinence (using ICIQ-UI SF), bowel incontinence (using RFIS), women’s performance of PFME and their confidence in this (using PFMSES) and their general health (using SF12).Results777 women were sent a questionnaire and 241 (31%) returned a completed questionnaire. There was no difference in the completion rate of the UI questions according to questionnaire length: 30.5% (119/387) of the women in the long questionnaire arm answered the UI questions compared with 31.5% (123/390) of those in the short questionnaire arm. ConclusionsThis study has used high quality trial methods and shown that response rates to the postpartum UI questions were comparable from either a longer or shorter questionnaire. Trial RegistrationISRCTN Registry: ISRCTN99859966. Date registered: 10/09/2018: http://www.isrctn.com/ISRCTN99859966
Evaluation of the effect of an antenatal pelvic floor muscle exercise programme on female sexual function during pregnancy and the first 3 months following birth: study protocol for a pragmatic randomised controlled trial
