Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence (TREAT-UI)
|ClinicalTrials.gov Identifier: NCT02239796|
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : May 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke Urinary Incontinence||Device: NeuroTrac continence stimulators||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
12 stimulation sessions of 30 minutes duration, delivered twice weekly over a 6 week period using a NeuroTrac continence stimulator.
Two surface electrodes are applied to the non-hemiparetic ankle, where appropriate, or the right ankle where no hemiparesis exists. The electrical stimulator is pre-programmed to safely deliver 30 minutes of continuous stimulation with a pulse frequency of 10 hertz and pulse width 200µs22. The intensity of the current will depend on the stroke survivor's perception threshold and individual comfort and is self-adjusted at each session, but will normally range between 15 and 40 milliamps.
Device: NeuroTrac continence stimulators
Electrically stimulating the sacral nerve plexus modulates the L4-S3 nerve roots that control bladder function and urethral sphincter activity to eliminate inappropriate detrusor contractions while leaving the micturition reflex intact.
Transcutaneous posterior tibial nerve stimulation (TPTNS) is a technique of non-invasive retrograde electrical stimulation of the sacral plexus via the sciatic nerve. The posterior tibial nerve, a tributary of the sciatic nerve, is accessed using surface electrodes applied to the medial malleolar area. We are using NeuroTrac continence stimulators.
Sham Comparator: Sham TPTNS
The sham stimulation group will self- or carer-deliver a similar programme of twelve, 30 minute sessions twice weekly for 6 weeks NeuroTrac continence stimulator.
The surface electrodes will be positioned on the lateral malleolar area of the ankle, not the medial aspect, to avoid the posterior tibial nerve.
The stimulation intensity will be increased until sensation is reported, then turned down to 4mA for the 30 minute session, ensuring that despite avoiding the posterior tibial nerve, there is no therapeutic stimulation provided.
Device: NeuroTrac continence stimulators
We are using NeuroTrac continence stimulators.
- Frequency of reported episodes of urinary incontinence as a measure of effectiveness. [ Time Frame: 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.
- Changes in the severity of urinary incontinence episodes experienced. [ Time Frame: Up to 16 months ]
- Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: Up to 16 months ]
- Changes in severity of urinary urgency, frequency and nocturia. [ Time Frame: Up to 16 months ]By completion of AUASI
- Urinary symptoms experienced on the American Urological Association Symptom Index [ Time Frame: Up to 16 months ]
- Mean Urgency Perception Scores recorded on a 3 day bladder diary [ Time Frame: Up to 16 months ]
- Patient Perception of Bladder Condition [ Time Frame: Up to 16 months ]
- Severity of bowel symptoms [ Time Frame: Up to 16 months ]
- Patient Perception of Bowel Condition [ Time Frame: up to 16 months ]
- Changes in post-void residual urine volume. [ Time Frame: Up to 16 months ]
- Amount of urine leakage in 24 hours [ Time Frame: Up to 16 months ]
- Participants perception of independence from any help with activities of daily living [ Time Frame: Up to 16 months ]Measured by completion of the Barthel Index Score and Modified Rankin Score.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239796
|NHS Ayrshire and Arran|
|Ayrshire, United Kingdom|
|Glasgow, United Kingdom|
|Principal Investigator:||Joanne Booth||Glasgow Caledonian University|