STARTUP V1
Research type
Research Study
Full title
Stimulation of the Tibial Nerve – A randomised trial for urinary problems associated with Parkinson’s - The STARTUP trial
IRAS ID
241253
Contact name
Doreen McClurg
Contact email
Sponsor organisation
Glasgow Caledonian University
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Background: Bladder symptoms affect 75% of people with Parkinson’s and include a frequent and urgent desire to pass urine, leading to reluctance to go out, frequent disruption of sleep and poor quality of life.
We held a workshop during which Parkinson's patients and clinicians discussed the lack of current effective treatments and stimulating a nerve near the ankle using skin electrodes was clearly an attractive new option.
Methods: We will recruit 208 patients with Parkinson’s and bladder problems from 6 movement disorder clinics across the UK. Each patient will be provided with written information about the study and an opportunity to ask questions before completing a consent form. A nurse will then show the participant how to use the stimulator which is a small hand held unit similar to a TENS machine. Half of those recruited (i.e. 100) will receive the actual electrical stimulation in which two small pads are applied to the ankle close to the nerve that supplies the bladder area. The other half will get sham stimulation i.e. the pads will be placed on the leg but not over the nerve. Treatment lasts for 6 weeks and the participant or a carer will apply it twice a week at home, for 30 minutes. All participants will receive a weekly follow-up telephone call during the 6 weeks of intervention. Participants will not know to which group they have been assigned. Changes in bladder symptoms will be recorded at the end of the time using the stimulator (Week 6) and again 6 weeks later. We will look at the likely cost and cost savings for the NHS.
Results: Should the results show that the use of active stimulation reduces bladder symptoms, we can use the information to get it more widely used.REC name
East of Scotland Research Ethics Service REC 1
REC reference
18/ES/0042
Date of REC Opinion
10 May 2018
REC opinion
Further Information Favourable Opinion