Tibial nerve stimulation to improve bladder symptoms in Parkinson's

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11484954

Enrollment

220

Registered

2021-06-22

Start date

2021-09-02

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder symptoms in Parkinson's Nervous System Diseases Parkinson disease

Interventions

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 stim

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, United Kingdom

Contacts

Public ContactMatthew Smith

matthew.smith@bristol.ac.uk+44 117 428 3112

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026