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Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence (TREAT-UI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02239796
Recruitment Status : Completed
First Posted : September 15, 2014
Last Update Posted : May 26, 2016
Sponsor:
Collaborators:
The Stroke Association, United Kingdom
University of Central Lancashire
Nursing, Midwifery & Allied Health Professions Research Unit
NHS Greater Glasgow and Clyde
NHS Lanarkshire
Information provided by (Responsible Party):
Glasgow Caledonian University

Tracking Information
First Submitted Date  ICMJE August 12, 2014
First Posted Date  ICMJE September 15, 2014
Last Update Posted Date May 26, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2014)
  • 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 Barthel Index Score [ Time Frame: Up to 16 months ]
  • Changes in Modified Rankin Score [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence
Official Title  ICMJE A Feasibility Study for a Randomised Controlled Trial of Transcutaneous Posterior Tibial Nerve Stimulation to Alleviate Stroke-related Urinary Incontinence.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Urinary Incontinence
Intervention  ICMJE
  • 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.

  • Device: NeuroTrac continence stimulators
    We are using NeuroTrac continence stimulators.
Study Arms  ICMJE
  • Experimental: TPTNS

    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.

    Intervention: Device: 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.

    Intervention: Device: NeuroTrac continence stimulators
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2016)
54
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2014)
80
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02239796
Other Study ID Numbers  ICMJE TSA 2013/05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Glasgow Caledonian University
Study Sponsor  ICMJE Glasgow Caledonian University
Collaborators  ICMJE
  • The Stroke Association, United Kingdom
  • University of Central Lancashire
  • Nursing, Midwifery & Allied Health Professions Research Unit
  • NHS Greater Glasgow and Clyde
  • NHS Lanarkshire
Investigators  ICMJE
Principal Investigator: Joanne Booth Glasgow Caledonian University
PRS Account Glasgow Caledonian University
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP