ISRCTN12437878
Completed
N/A
A multicentre randomised trial of the effectiveness of transcutaneous tibial nerve stimulation (TTNS) to reduce lower urinary tract symptoms in people with Parkinson’s
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson’s disease with lower urinary tract symptoms
- Sponsor
- Glasgow Caledonian University
- Enrollment
- 208
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2020 Protocol article in https://doi.org/10.1136/bmjopen-2019-034887 (added 23/08/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Diagnosis of Parkinson's disease with self\-reported problematic LUT symptoms
- •2\. Capacity to consent/complete self\-report outcome measures
- •3\. Ability to apply TTNS (or placebo) independently or has carer who can apply for duration
- •4\. Stable Parkinson’s medication, treatment naïve, treatment failed or continuing treatment with anti\-muscarinic medication (group allocation will be minimised to account for these groups).
Exclusion Criteria
- •1\. Pacemaker or implanted electrical device
- •2\. Ulceration or broken skin in area of pad placement
- •3\. History of gynaecological, urological cancer, prostate cancer
- •4\. History of peripheral vascular disease, epilepsy or current urinary tract infection (as per dip stick analysis)
- •5\. Pace\-maker, sacral nerve stimulator, receipt of Botox or PTNS within the last year
- •6\. Severe prostatic enlargement as determined by treating clinician
Outcomes
Primary Outcomes
Not specified
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