Using tibial nerve stimulation to treat neurogenic bladder dysfunction
Transcutaneous Tibial Nerve Stimulation (TTNS) for Treating Neurogenic Lower Urinary Tract Dysfunction: a Multicentre, Randomised, Sham-controlled, Double-blind Clinical Trial
NA · University of Zurich · NCT04315142
This study is testing if a new non-invasive treatment using tibial nerve stimulation can help people with neurogenic bladder problems that haven't improved with regular medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich (other) |
| Locations | 12 sites (Edegem and 11 other locations) |
| Trial ID | NCT04315142 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of transcutaneous tibial nerve stimulation (TTNS) as a non-invasive treatment for patients suffering from neurogenic lower urinary tract dysfunction (NLUTD). The study compares the effects of TTNS against a sham treatment in individuals with refractory neurogenic bladder issues, aiming to improve their quality of life. Participants must have experienced urinary dysfunction that has not responded to conventional medications. The trial seeks to provide insights into the potential benefits of neuromodulation therapies for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with refractory neurogenic bladder dysfunction due to a neurological disorder.
Not a fit: Patients who have not undergone recent urodynamic investigations or those whose bladder dysfunction is not refractory to standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve urinary function and quality of life for patients with neurogenic bladder dysfunction.
How similar studies have performed: Previous studies have shown that tibial nerve stimulation is effective for idiopathic overactive bladder, but its application in neurological patients is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. 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) 2. 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) 3. 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 Criteria: * 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
Where this trial is running
Edegem and 11 other locations
- University Hospital Antwerp — Edegem, Belgium (SUSPENDED)
- University of Sao Paulo School of Medicine — São Paulo, Brazil (SUSPENDED)
- Careggi University Hospital — Florence, Italy (SUSPENDED)
- Tor Vergata University Hospital — Rome, Italy (SUSPENDED)
- Cantonal Hospital Winterthur — Winterthur, Zurich, Switzerland (RECRUITING)
- Cantonal Hospital Aarau — Aarau, Switzerland (RECRUITING)
- REHAB Basel — Basel, Switzerland (SUSPENDED)
- EOC - Regional Hospital Bellinzona and Valleys — Bellinzona, Switzerland (SUSPENDED)
- Inselspital Bern, University Hospital — Berne, Switzerland (RECRUITING)
- Centre hospitalier universitaire vaudois CHUV — Lausanne, Switzerland (RECRUITING)
- Cantonal Hospital St. Gallen — Sankt Gallen, Switzerland (RECRUITING)
- Balgrist University Hospital — Zürich, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Thomas M Kessler, Prof.
- Email: thomas.kessler@balgrist.ch
- Phone: 0041 44 386 39 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurogenic Bladder Dysfunction, Randomized, Sham-controlled, Transcutaneous tibial nerve stimulation, Neurogenic detrusor overactivity, Neuromodulation