Bladder and TranscUtaneous Tibial Nerve Stimulation for NEurogenic Lower Urinary Tract Dysfunction

Last updated: November 12, 2024
Sponsor: University of Zurich
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Experimental TTNS

Sham TTNS

Clinical Study ID

NCT04315142
bTUNED
  • Ages > 18
  • All Genders

Study 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 incontinence and voiding dysfunction. In addition, the upper urinary tract may be jeopardized because of high intravesical pressure caused by detrusor overactivity (DO) with concurrent detrusor-sphincter-dyssynergia and/or low bladder compliance.

The treatment of NLUTD is a challenge since conventional conservative therapies often fail and more invasive treatments such as intradetrusor onabotulinumtoxinA injections, bladder augmentation and urinary diversion have to be considered. Neuromodulation therapies including tibial nerve stimulation (TNS) may be alternative non-invasive treatment options.

Indeed, TNS is an effective and safe treatment for idiopathic overactive bladder proven in randomised controlled trials (RCTs), but its value in neurological patients is unclear. In a recent systematic review, the investigators found evidence that TNS might become a promising treatment option for NLUTD, however, more reliable data from well-designed RCTs are urgently needed to reach definitive conclusions.

However, this study will be the first adequately sampled and powered, randomised, sham-controlled, double-blind trial assessing transcutaneous TNS (TTNS) for NLUTD. It will provide significant insights into the efficacy of TTNS in patients suffering from NLUTD and in the case that this treatment is really effective in the neurological population, the investigators findings would completely revolutionize the management of NLUTD in daily clinical practice. Moreover, this interdisciplinary clinical trial will relevantly influence the neurological and urological approach in the management of NLUTD promoting future collaborative projects improving patients' medical care and underlying the pioneering role of Switzerland in the rapidly developing and ambitious research field of neuro-urology.

Eligibility Criteria

Inclusion

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 medicationsince then

  • Refractory LUTD due to a neurological disorder:

  1. Neurogenic OAB (i.e. urgency frequency syndrome with or without urgencyincontinence) refractory to antimuscarinics (pharmacotherapy for at least 4weeks with at least 2 antimuscarinics)

  2. Neurogenic voiding dysfunction (i.e. incomplete bladder emptying/incomplete /complete urinary retention) refractory to alpha-blocker (pharmacotherapy withan alpha-blocker for at least 4 weeks)

  3. Combination of neurogenic OAB and neurogenic voiding dysfunction (i.e. urgencyfrequency syndrome with or without urgency incontinence and incomplete /complete urinary retention) refractory to antimuscarinics (pharmacotherapy forat 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 duringthe entire study period (from screening till unblinding)

Exclusion

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 30days preceding and during the present study

  • Neuromodulation treatment for urological indication in the last six months orongoing

  • Botulinum toxin injections in the detrusor and/or urethral sphincter in the last sixmonths

  • 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 HumanSubjects 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 dependentpersons

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Experimental TTNS
Phase:
Study Start date:
March 01, 2020
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • 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

    Active - Recruiting

  • Cantonal Hospital Aarau

    Aarau,
    Switzerland

    Active - Recruiting

  • REHAB Basel

    Basel,
    Switzerland

    Suspended

  • EOC - Regional Hospital Bellinzona and Valleys

    Bellinzona,
    Switzerland

    Suspended

  • Inselspital Bern, University Hospital

    Berne,
    Switzerland

    Active - Recruiting

  • Centre hospitalier universitaire vaudois CHUV

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • Cantonal Hospital St. Gallen

    Sankt Gallen,
    Switzerland

    Active - Recruiting

  • Balgrist University Hospital

    Zurich, 8008
    Switzerland

    Site Not Available

  • Balgrist University Hospital

    Zürich,
    Switzerland

    Active - Recruiting

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