MethodsThis is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow up phone call and access to a local telephone number for clinical support. The control group will receive the clinic based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition‐specific quality of life at 18 months’ post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months’ post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper.
DiscussionThe results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic based care in terms of improving women's quality of life, and of its cost-effectiveness.
|Publication status||Accepted/In press - 25 Mar 2020|
- quality of life
- economic evaluation
- randomised controlled trial (RCT)