Tibial nerve stimulation to improve bladder symptoms in Parkinson's
| ISRCTN | ISRCTN11484954 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11484954 |
| IRAS number | 295856 |
| Secondary identifying numbers | IRAS 295856 |
- Submission date
- 06/05/2021
- Registration date
- 22/06/2021
- Last edited
- 04/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims:
Bladder symptoms are extremely common in Parkinson’s disease (PD) and have a profound impact on quality of life. Transcutaneous tibial nerve stimulation (TTNS) is a potential method of treating overactive bladder symptoms in neurological disorders. If effective, this will improve bladder symptoms in PD without side effects encountered with drugs and potentially prevent falls and hospital admission associated with urinary disorders.
Who can participate:
People with Parkinson's with bladder symptoms (not caused by any obvious structural problem)
What does the study involve:
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). One group of participants will be asked to use a small, self-adhesive stimulator device that affects the bladder, called Geko, on the lower leg, twice per week for 30 min at a time, over 12 weeks. The other group of participants will use the same device at a lower stimulation strength that does not affect the bladder. The treatment itself is given at home by the participant. Participants will be asked to rate their bladder symptom score with a questionnaire every other week, and more thorough bladder testing will be organised just before and just after the 12 week period at the Royal United Hospital in Bath (UK). This will require a visit to the research clinic, but the stimulation treatment is given at home by the participants themselves.
What are the possible benefits and risks of participating?
It is hoped that tibial nerve stimulation using the Geko device will improve bladder symptoms. It is hoped that the Geko device will be easy to use without any possible trip hazards of using other methods explored in the past such as TENS machines. The Geko device is already licensed in the UK for another purpose and the only main side effect can be some skin irritation (which is rare).
Where is the study run from?
The University of Bristol (UK)
When is the study starting and how long is it expected to run for?
From February 2021 to April 2024
Who is funding the study?
The Gatsby Charitable Foundation (UK)
Who is the main contact?
Dr Matthew Smith
matthew.smith@bristol.ac.uk
Contact information
Public, Scientific
University of Bristol
1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom
 ORCID ID |
0000-0002-5327-369X |
|---|---|
| Phone | +44 117 428 3112 |
| matthew.smith@bristol.ac.uk |
Study information
| Study design | Single-blinded randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | STRIPE (Stimulation of the Tibial nerve Repetitively to Improve Incontinence in Parkinson’s disease Electronically): A randomised controlled trial of tibial nerve stimulation to improve bladder symptoms in patients with idiopathic Parkinson’s disease |
| Study acronym | STRIPE |
| Study hypothesis | Tibial nerve stimulation provided by a novel self-adhesive device will improve bladder symptoms in Parkinson's |
| Ethics approval(s) | Approved 24/06/2021, London - Camden & Kings Cross Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle/London, NE2 4NQ, UK; +44 (0)207 104 8233; CamdenandKingsCross.REC@hra.nhs.uk), ref: 21/LO/0418, 21/NI/0091 |
| Condition | Bladder symptoms in Parkinson's |
| Intervention | Tibial nerve stimulation using the Geko device, a self adhesive neuromuscular stimulator. This will be compared to a placebo arm using this device, in a way that does not provide threshold nerve stimulation. Stimulation will be given twice per week for 30 min, for a period of 12 weeks. Participants will be randomised electronically using a minimisation technique. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Geko |
| Primary outcome measure | Quality of life measured using the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) at baseline, 2, 4, 6, 8, 10, 12, 16, 20, and 24 weeks |
| Secondary outcome measures | 1. Urinary frequency rate, incontinence episodes, and nocturia measured using a bladder diary at baseline and 12 weeks 2. Quality of life measured using the ICIQ-OABqol and the EuroQol 5-dimension (EQ5D) questionnaires at baseline and 12 weeks 3. Mood measured using the Patient Health Questionnaire-9 (PHQ9) at baseline and 12 weeks 4. Neurogenic bowel dysfunction measured using the Neurogenic bowel score at baseline and 12 weeks 5. Bladder function measured using uroflowmetry and post-void residual at baseline and 12 weeks 6. Autonomic function measured using Scales for Outcomes in Parkinson’s Disease - Autonomic Dysfunction (SCOPA-AUT) questionnaire at baseline and 12 weeks 7. Device tolerability and adverse events measured using participant diaries between baseline and 12 weeks |
| Overall study start date | 02/02/2021 |
| Overall study end date | 01/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 220 |
| Total final enrolment | 148 |
| Participant inclusion criteria | 1. Idiopathic Parkinson’s Disease 2. Ability to consent 3. Aged ≥18 years 4. Determined to have significant bladder symptoms as defined by questionnaire response within PRIME-Parkinson study or referred from non-PRIME centres at recommendation of local clinician due to bladder symptoms |
| Participant exclusion criteria | 1. Parkinsonism of any other aetiology such as but not limited to drug-induced Parkinsonism (DIP), multiple system atrophy (MSA), corticobasal degeneration (CBD), vascular parkinsonism, and progressive supranuclear palsy (PSP) 2. Clinical diagnosis of dementia 3. Recent bladder medication 4. Implantable electronic device 5. Abnormality of both lower limbs 6. Limited life expectancy 7. Severe BPH or history of urological cancer |
| Recruitment start date | 02/09/2021 |
| Recruitment end date | 09/06/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Coombe Park
Bath
BA1 3NG
United Kingdom
Sponsor information
University/education
Beacon House
Queens Road
Bristol
BS8 1QU
England
United Kingdom
| Phone | +44 (0)117 928 9000 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | www.bristol.ac.uk |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- THE GATSBY CHARITABLE FOUNDATION, GATSBY
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 06/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned dissemination of results in peer-reviewed journals, national/international conferences, and Parkinsons UK research events |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Matthew Smith (matthew.smith@bristol.ac.uk) after August 2024. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 28/10/2022 | 31/10/2022 | Yes | No |
Editorial Notes
04/03/2025: An email address was changed throughout the record and the intention to publish date was changed from 06/06/2024 to 06/04/2025.
11/10/2023: The following changes were made to the study record:
1. Ethics approval details added.
2. The overall study end date was changed from 04/12/2023 to 01/04/2024.
3. Total final enrolment added.
21/03/2023: The recruitment end date was changed from 09/03/2023 to 09/06/2023.
31/10/2022: Publication reference added.
14/06/2021: Trial’s existence confirmed by London - Camden & Kings Cross Research Ethics Committee.
