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

Stroke Clinical Trial

— TREAT-UI  

Official title:

A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239796
• Other study ID #: TSA 2013/05
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: May 25, 2016
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Urinary Incontinence

Intervention

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.
• NeuroTrac continence stimulators
We are using NeuroTrac continence stimulators.

Locations

Country	Name	City	State
United Kingdom	NHS Ayrshire and Arran	Ayrshire
United Kingdom	NHS Lanarkshire	Glasgow

Sponsors (6)

Lead Sponsor	Collaborator
Glasgow Caledonian University	NHS Greater Glasgow and Clyde, NHS Lanarkshire, Nursing, Midwifery & Allied Health Professions Research Unit, The Stroke Association, United Kingdom, University of Central Lancashire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of reported episodes of urinary incontinence as a measure of effectiveness.	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.	Up to 16 months	No
Secondary	Changes in the severity of urinary incontinence episodes experienced.		Up to 16 months	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability.		Up to 16 months	Yes
Secondary	Changes in severity of urinary urgency, frequency and nocturia.	By completion of AUASI	Up to 16 months	No
Secondary	Urinary symptoms experienced on the American Urological Association Symptom Index		Up to 16 months	No
Secondary	Mean Urgency Perception Scores recorded on a 3 day bladder diary		Up to 16 months	No
Secondary	Patient Perception of Bladder Condition		Up to 16 months	No
Secondary	Severity of bowel symptoms		Up to 16 months	No
Secondary	Patient Perception of Bowel Condition		up to 16 months	No
Secondary	Changes in post-void residual urine volume.		Up to 16 months	No
Secondary	Amount of urine leakage in 24 hours		Up to 16 months	No
Secondary	Participants perception of independence from any help with activities of daily living	Measured by completion of the Barthel Index Score and Modified Rankin Score.	Up to 16 months	No