Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence

Not Applicable

Completed

• Conditions: Urinary Incontinence; Stroke

• Registration Number: NCT02239796
• Lead Sponsor: Glasgow Caledonian University

Brief Summary

To aim of this study is to establish the feasibility of undertaking a phase III trial of transcutaneous posterior tibial nerve electrical stimulation (TPTNS) to alleviate stroke-related urinary incontinence.

Detailed Description

Stroke-related 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, together with overactive bladder (OAB) symptoms (frequency, urgency, nocturia), is most commonly experienced. 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. Intermittent electrical stimulation of the posterior tibial nerve (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 urinary incontinence in the stroke population.

Study Timeline

• Study First Submitted: 2014-08-12
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Status Verified: 2016-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Men or women aged ≥ 18 years, with a diagnosis of stroke based on the WHO criteria (WHO 1989) and stroke-related urinary incontinence of at least once weekly.
• Onset of stroke ≥ 4 weeks previously and discharged from hospital to own home following a new stroke episode within the previous 6 months.
• Physically, cognitively and communicatively able and willing to learn to apply TPTNS or has carer who is able and willing to learn.

Exclusion Criteria

• Pre-existing urinary incontinence prior to stroke.
• Current Urinary Tract Infection.
• Voiding dysfunction requiring intermittent/indwelling catheterisation.
• Cardiac pacemaker in situ.
• Concurrent neurological diagnosis eg dementia, Multiple Sclerosis, diabetic neuropathy.
• Reduced/absent sensation at electrode placement sites.
• Post-void residual urine volume of > 150ml.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency of reported episodes of urinary incontinence as a measure of effectiveness.	Up to 16 months	Positive response to International Consultation on Incontinence Questionnaire-Urinary Incontinence Short-Form (ICIQ-UI SF).; This outcome will be the primary outcome for a future full evaluation trial, should it prove feasible.

Secondary Outcome Measures

Name	Time	Method
Changes in the severity of urinary incontinence episodes experienced.	Up to 16 months
Number of participants with adverse events as a measure of safety and tolerability.	Up to 16 months
Changes in severity of urinary urgency, frequency and nocturia.	Up to 16 months	By completion of AUASI
Urinary symptoms experienced on the American Urological Association Symptom Index	Up to 16 months
Mean Urgency Perception Scores recorded on a 3 day bladder diary	Up to 16 months
Patient Perception of Bladder Condition	Up to 16 months
Severity of bowel symptoms	Up to 16 months
Patient Perception of Bowel Condition	up to 16 months
Changes in post-void residual urine volume.	Up to 16 months
Amount of urine leakage in 24 hours	Up to 16 months
Participants perception of independence from any help with activities of daily living	Up to 16 months	Measured by completion of the Barthel Index Score and Modified Rankin Score.

Trial Locations

Locations (2)

NHS Ayrshire and Arran; 🇬🇧 Ayrshire, United Kingdom

NHS Lanarkshire; 🇬🇧 Glasgow, United Kingdom