Stimulation of the Tibial nerve – A Randomised Trial for Urinary problems associated with Parkinson’s disease (STARTUP)

Not Applicable

Completed

• Conditions: Parkinson’s disease with lower urinary tract symptoms; Nervous System Diseases

• Registration Number: ISRCTN12437878
• Lead Sponsor: Glasgow Caledonian University

Brief Summary

2020 Protocol article in https://doi.org/10.1136/bmjopen-2019-034887 (added 23/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-22
• Study Completion: 2021-04-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified