Feasibility RCT of TPTNS for stroke-related urinary incontinence V1.0
Research type
Research Study
Full title
A feasability study for a randomised controlled trial of transcutaneous posterior tibial nerve stimulation to alleviate stroke-related urinary incontinence.
IRAS ID
158809
Contact name
Joanne Booth
Contact email
Sponsor organisation
Glasgow Caledonian University
Research summary
Urinary incontinence (UI) persists in more than one third of stroke survivors. It is associated with significant burden including reduced quality of life, increased morbidity and disability. Urgency UI is most commonly experienced, together with overactive bladder (OAB) symptoms of frequency, urgency, nocturia. Current continence care is limited to lifestyle advice and behavioural interventions such as voiding programmes. There is a reliance on containment approaches and a lack of available options for active treatment of UI to reduce or eliminate leakage. Intermittent electrical stimulation of the posterior tibial nerve (transcutaneous posterior tibial nerve electrical stimulation (TPTNS) is effective for treating non-stroke neurogenic UI and OAB, but has not been tested in the stroke population. This pilot randomised controlled trial (RCT) aims to test the potential effectiveness of TPTNS for stroke-related bladder dysfunction. Adults with stroke-related UI will be randomised to TPTNS or sham. They and/or their carer will be taught to self-deliver a programme of TPTNS over a six week period. Bladder function, associated healthcare costs and quality of life outcomes will be measured at 6, 12 and 26 weeks. A nested process evaluation will be conducted. Pilot RCT and process evaluation results will inform the design of a phase III RCT of TPTNS to treat UI in the stroke population.
REC name
Scotland A REC
REC reference
14/SS/1034
Date of REC Opinion
2 Oct 2014
REC opinion
Further Information Favourable Opinion