Status:

COMPLETED

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

Lead Sponsor:

Glasgow Caledonian University

Collaborating Sponsors:

The Stroke Association, United Kingdom

University of Central Lancashire

Conditions:

Stroke

Urinary Incontinence

Eligibility:

All Genders

18+ years

Phase:

NA

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 incont...

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 disabi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2016

Estimated Enrollment :

54 Patients enrolled

Trial Details

Trial ID

NCT02239796

Start Date

September 1 2014

End Date

May 1 2016

Last Update

May 26 2016

Active Locations (2)

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Page 1 of 1 (2 locations)

1

NHS Ayrshire and Arran

Ayrshire, United Kingdom

2

NHS Lanarkshire

Glasgow, United Kingdom