Status:
TERMINATED
Bladder and TranscUtaneous Tibial Nerve Stimulation for nEurogenic Lower Urinary Tract Dysfunction
Lead Sponsor:
University of Zurich
Conditions:
Neurogenic Bladder Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Many patients with neurological diseases suffer from neurogenic lower urinary tract dysfunction (NLUTD), which often severely impairs quality of life, due to urinary urgency with or without incontinen...
Eligibility Criteria
Inclusion
- Informed consent
- Age ≥18 years
- Last urethro-cystoscopy and bladder washing cytology within 1 year before inclusion
- Last urodynamic investigation within 6 months and no change of bladder medication since then
- Refractory LUTD due to a neurological disorder:
- Neurogenic OAB (i.e. urgency frequency syndrome with or without urgency incontinence) refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics)
- Neurogenic voiding dysfunction (i.e. incomplete bladder emptying/incomplete / complete urinary retention) refractory to alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
- Combination of neurogenic OAB and neurogenic voiding dysfunction (i.e. urgency frequency syndrome with or without urgency incontinence and incomplete / complete urinary retention) refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) and alpha-blocker (pharmacotherapy with an alpha- blocker for at least 4 weeks)
- Motor response induced by TTNS stimulation at least at one leg
- Willing not to change or start any new medications or treatments for the LUT during the entire study period (from screening till unblinding)
Exclusion
- Contraindications to the investigational product
- Known or suspected non-adherence, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
- Participation in another study with investigational drug or product within the 30 days preceding and during the present study
- Neuromodulation treatment for urological indication in the last six months or ongoing
- Botulinum toxin injections in the detrusor and/or urethral sphincter in the last six months
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences \[www.samw.ch/en/News/News.html\]
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04315142
Start Date
March 1 2020
End Date
July 30 2025
Last Update
August 11 2025
Active Locations (12)
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1
University Hospital Antwerp
Edegem, Belgium
2
University of Sao Paulo School of Medicine
São Paulo, Brazil
3
Careggi University Hospital
Florence, Italy
4
Tor Vergata University Hospital
Rome, Italy