Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial

Abstract

Funding: This trial was funded by the National Institute for Health Research (NIHR), Health Technology Assessment programme (project No 11/71/03). The Chief Scientist Office, Scottish Government Health and Social Care Directorates funded SH's post, and the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula at the Royal Devon and Exeter NHS Foundation Trust supported SD. The study funders had no role in the study design, data collection, data analysis, data interpretation, writing of the manuscript, or decision to submit for publication. The research team was independent from the funders. All authors had access to all study data and take responsibility for its integrity and the accuracy of the data analysis. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care. The trial sponsor was Glasgow Caledonian University. Data sharing: Individual participant data collected for this trial, and a data dictionary defining each field in the dataset, will be made available to others; all available data will be de-identified participant data. The protocol, statistical analysis plan, informed consent form, and ethics committee approval are available (https://www.journalslibrary.nihr.ac.uk/programmes/hta/117103/#/). To access data, a request should be submitted to the corresponding author (s.hagen@gcu.ac.uk) with a scientific proposal including objectives. Written proposals will be assessed by members of the trial steering committee and a decision made about the appropriateness of the request. The data will only be shared after the data sharing agreement is fully executed. ; Peer reviewed ; Publisher PDF