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

NCT02239796 | Completed

• 1 other identifier: TSA 2013/05
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke; Urinary Incontinence

Keywords

transcutaneous posterior tibial nerve stimulation; Randomised controlled trial; Feasibility

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

• 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

Study Arms (2)

TPTNS

EXPERIMENTAL

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

Sham TPTNS

SHAM COMPARATOR

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

Interventions

NeuroTrac continence stimulators DEVICE

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.

TPTNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• The Stroke Association, United Kingdom: collaborator
• University of Central Lancashire: collaborator
• Nursing, Midwifery & Allied Health Professions Research Unit: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• NHS Lanarkshire: collaborator

Study Sites (2)

NHS Ayrshire and Arran

Ayrshire, United Kingdom

Location

NHS Lanarkshire

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Urinary Incontinence

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joanne Booth

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 26, 2016

Record last verified: 2016-02

Locations

GB (2)