Neurogenic Bladder DysfunctionbTUNEDNCT04315142
Bladder and TranscUtaneous Tibial Nerve Stimulation for nEurogenic Lower Urinary Tract Dysfunction
A study testing Experimental TTNS in people with Neurogenic Bladder Dysfunction, run by University of Zurich at 12 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder Dysfunction
- What is being tested?
- Experimental TTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 1 Mar 2020to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Switzerland8 sites
Cantonal Hospital Aarau
Aarau
REHAB Basel
Basel
EOC - Regional Hospital Bellinzona and Valleys
Bellinzona
Inselspital Bern, University Hospital
Bern, Canton of Bern
Centre hospitalier universitaire vaudois CHUV
Lausanne, 1011
Cantonal Hospital St. Gallen
Sankt Gallen
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich
Balgrist University Hospital
Zurich
Italy2 sites
Careggi University Hospital
Florence
Tor Vergata University Hospital
Rome
About this study
Official title: Transcutaneous Tibial Nerve Stimulation (TTNS) for Treating Neurogenic Lower Urinary Tract Dysfunction: A Multicentre, Randomised, Sham-controlled, Double-blind Clinical Trial
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.
Read more
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.
- Conditions
- Neurogenic Bladder Dysfunction
- Being tested
- Experimental TTNS, Sham TTNS
- Keywords
- Randomized, Sham-controlled, Transcutaneous tibial nerve stimulation (TTNS), Neurogenic detrusor overactivity, Neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental TTNSDevice
30-minute TTNS intervention is performed 2 days a week during a treatment period of 6 weeks
Sham TTNSDevice
30-minute sham intervention is performed 2 days a week during a treatment period of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous tibial nerve stimulation (TTNS) | Experimental | Not described Receives: Device: Experimental TTNS |
| TTNS sham stimulation | Sham comparator | Not described Receives: Device: Sham TTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of TTNS
Success of TTNS defined as:
- ≥50% reduction in incontinence rates per 24 hours and/or ≥50% reduction in micturition/catheterization frequency per 24 hours in patients with neurogenic overactive bladder (OAB)
- Reduction of post void residual (PVR) below 25% of bladder capacity if bladder capacity
- 100 mL, or below 50% of bladder capacity if bladder capacity <100 mL in patients with neurogenic voiding dysfunction
- In patients with combined neurogenic OAB and neurogenic voiding dysfunction: The success criteria of leading symptom/dysfunction will be chosen
Measured: study week 8 / study end
Secondary outcomes (22)
Volumetric changes during urodynamics and their relation to clinical outcomes
Cystometric capacity [mL], volume at first DO [mL], voided volume [mL] and post void residual [mL] as assessed by urodynamic measurement
Measured: Baseline; study week 8 / study end
Changes in bladder compliance [mL/cmH2O] during urodynamics and their relation to clinical outcomes
Measured: Baseline; study week 8 / study end
Pressure changes during urodynamics and their relation to clinical outcomes
Maximum DO pressure [cmH2O], detrusor leak-point pressure [cmH2O], maximum detrusor pressure [cmH2O] during storage phase, maximum detrusor pressure [cmH2O] during voiding phase, detrusor pressure at maximum flow rate [cmH2O] as assessed by urodynamic measurement
Measured: Baseline; study week 1-8 / study end
Changes in maximum flow rate [mL/s] as assessed by urodynamics and their relation to clinical outcomes
Measured: Baseline; study week 8 / study end
Changes in vesicoureterorenal reflux (VUR) as assessed by videography during urodynamics and their relation to clinical outcomes
Measured: Baseline; study week 8 / study end
Changes in pelvic floor activity as assessed by electromyography (EMG) during urodynamics and their relation to clinical outcomes
Measured: Baseline; study week 8 / study end
Changes in bladder storage and voiding parameters and their relation to clinical outcomes
Assessed by a bladder diary
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in bowel diary parameters and their relation to clinical outcomes
Assessed by a bowel diary
Measured: Baseline; study week 8 / study end
Goal attainment scaling assessed by a self-assessment goal achievement (SAGA) questionnaire
The baseline SAGA module asks patients to rate the importance of 9 prespecified (fixed) treatment goals that describe reducing the following LUTS: frequency (daytime and nighttime); sensation of pressure; primary sensation to use the bathroom; bladder voiding; starting or maintaining a urine stream; urine loss when coughing, laughing, exercising, or sneezing; urine leakage; and urgency. In addition to the 9 fixed goals, patients can list up to 5 additional (open) treatment goals. Patients rate the importance of each goal using a 5-point scale ranging from "not very important goal" to "very important goal." In the SAGA follow-up module, patients rate their achievement of each individualized goal and overall goal achievement with a 5-point scale ranging from "did not achieve goal" to "greatly exceeded goal."
Measured: Baseline; study week 8 / study end
Changes in International Prostate Symptom (IPSS) questionnaire and their relation to clinical outcomes
The IPSS ("International Prostate Symptom Questionnaire") score is based on questions concerning urinary symptoms and quality of life (QoL). It consists of 8 items covering 7 urinary symptoms related dimensions (subscales) and 1 additional item assessing quality of life. Each item is rated on a 6-point scale (0=not at all; 5=almost always). The lowest possible score in the total IPSS score is 0 (asymptomatic); the highest possible score is 35 (symptomatic). The QoL index is rated on a 7-point scale, with 0 indicating "delighted" and 6 "terrible."
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in urinary symptoms as assessed by the Urinary Symptom Profile (USP) questionnaire and their relation to clinical outcomes
The USP ("Urinary Symptom Profile") score is based on questions concerning urinary symptoms and their severity in males and females. It consists of 13 items covering 3 dimensions (subscales) with 7 overactive bladder (OAB), 3 stress urinary incontinence (SUI), and 3 low stream (LS) related items. Each item is rated on a 4-point scale. The lowest score is 0 (asymptomatic); the highest score is 3 (symptomatic).
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in Qualiveen questionnaire scores and their relation to clinical outcomes
Qualiveen-30 assesses the Specific Impact of Urinary Problems (SIUP) on Quality of Life. It consists of 30 items covering 4 domains, namely inconvenience (9 questions), restrictions (8 questions), fears (8 questions), and impact on daily life (5 questions). Each item is rated on a 5-point ordinal scale (0=asymptomatic; 4=symptomatic). The index of the SIUP on Quality of Life is the mean of the four individual scores. The lowest possible overall score in the Qualiveen-30 is 0 (Urinary problems have no specific impact on QoL); the highest possible score is 30 (Urinary problems have a huge specific impact on QoL).
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in Female Sexual Function Index (FSFI) and their relation to clinical outcomes
The FSFI ("Female Sexual Function Index") is based on questions concerning female sexual functions. It consists of 19 items covering 6 domains, namely sexual desire, arousal (both subjective and physiologic), lubrication, orgasm, satisfaction, and pain. The lowest possible score in the total FSFI is 2 (asymptomatic); the highest possible score is 36 (symptomatic).
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in International Index of Erectile Function (IIEF) and their relation to clinical outcomes
The IIEF ("International Index of Erectile Function") is based on questions concerning erectile dysfunction. It consists of 15 items covering 5 domains, namely erectile functioning, orgasmic functioning, sexual desire, and intercourse satisfaction along with a fifth component which encompasses the concept of overall sexual satisfaction. While items 1-10 are rated on a 6-point Likert-type scale from 0 to 5, items 11-15 are rated on a 5-point Likert-type scale from 1 to 5. Higher scores are reflecting less dysfunction. Domain scores are computed by summing the sores for individual items in each domain.
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Variability and validity of University of South Australia Urinary Symptom Assessment questionnaire (USA2) for treatment follow-up
The USA2 ("University of South Australia Urinary Symptom Assessment") assesses multiple dimensions of urgency sensation. 10 items are rated on a 6-point Likert-type scale from 0 to 5. Lower scores are reflecting lesser urgency symptoms. Domain scores are computed by summing the sores for individual items in each domain.
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in Neurogenic Bowel Dysfunction (NBD) questionnaire and their relation to clinical outcomes
The NBD ("Neurogenic Bowel Dysfunction") score is based on questions concerning constipation and fecal incontinence and was developed for and validated in the spinal cord injury population. It consists of 10 items. The lowest possible score in the total NBD is 0 (asymptomatic); the highest possible score is 47 (symptomatic). The interpretation of the total NBD score is very minor NBD (0-6), minor NBD (7-9), moderate NBD (10-13), and severe NBD (≥14).
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in neurophysiology measurements of evoked potentials (EPs) as well as nerve conduction measurements and their relation to clinical outcomes
Measured: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Volumetric changes during rectal sensitivity testing and barostat assessment and their relation to clinical outcomes
Initial sensation [mL], volume at urge to defecate [mL], maximum tolerated volume [mL] as assessed by rectal sensitivity testing; rectal capacity [mL] assessed by barostat assessment
Measured: Baseline; study week 8 / study end
Pressure changes during anorectal manometry and barostat assessment and their relation to clinical outcomes
Basal Internal anal sphincter pressure [mmHg], squeeze external anal sphincter pressure [mmHg], relaxation internal anal sphincter pressure during defecation [mmHg], intraabdominal pressure during defecation [mmHg]
Measured: Baseline; study week 8 / study end
Changes in rectal compliance [mL/cmH2O] during anorectal manometry and barostat assessment and their relation to clinical outcomes
Measured: Baseline; study week 8 / study end
Changes in defecatory disorder [Rao's classification] identified during anorectal manometry and their relation to clinical outcomes
Anorectal manometry is the preferable test for defecatory disorder. Rao's classification describes the four types manometric patterns (I-IV) that are identified through manometric assessments.
Measured: Baseline; study week 8 / study end
Incidence of side effects as well as number and intensity/severity (mild/moderate/severe) of AEs and SAE
Categories:
- infection - Urinary Tract Infection (UTI)
- infection - other than UTI
- skin irritation at the electrode site
- pressure ulcer
- severe neurological deterioration
- severe or sudden increase in pain
- severe or sudden increase in spasticity
- deep vein thrombosis / pulmonary embolism
- autonomic dysreflexia
- urgent (unexpected) transfer/admittance to an acute care facility
Measured: During complete study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Mar 2020
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Why it stopped: Difficulties in recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Bladder DysfunctionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315142
- Sponsor's protocol ID
- bTUNED
- Acronym
- bTUNED
- Status last verified
- Nov 2024
- First submitted
- 9 Mar 2020
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stalder SA, Gross O, Anderson CE, Bachmann LM, Baumann S, Birkhauser V, Bywater M, Del Popolo G, Engeler DS, Agro EF, Friedl S, Grilo N, Kiss S, Koschorke M, Leitner L, Liechti MD, Mehnert U, Musco S, Sadri H, Stachele L, Tornic J, van der Lely S, Wyler S, Kessler TM. bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction. BJU Int. 2023 Sep;132(3):343-352. doi: 10.1111/bju.16081. Epub 2023 Jun 13.
PubMed 37204144
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Tibial Nerve Stimulation (TTNS) for Treating Neurogenic Lower Urinary Tract Dysfunction: A Multicentre, Randomised, Sham-controlled, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04315142
- Acronym / sponsor ID
- bTUNED / bTUNED
- Conditions
- Neurogenic Bladder Dysfunction
- Keywords
- Randomized, Sham-controlled, Transcutaneous tibial nerve stimulation (TTNS), Neurogenic detrusor overactivity, Neuromodulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in recruiting participants
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous tibial nerve stimulation (TTNS) | Experimental | Device: Experimental TTNS |
| TTNS sham stimulation | Sham comparator | Device: Sham TTNS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental TTNS30-minute TTNS intervention is performed 2 days a week during a treatment period of 6 weeks | Device | Transcutaneous tibial nerve stimulation (TTNS) |
| Sham TTNS30-minute sham intervention is performed 2 days a week during a treatment period of 6 weeks | Device | TTNS sham stimulation |
Primary outcome
Success of TTNS
Time frame: study week 8 / study end
Success of TTNS defined as: * ≥50% reduction in incontinence rates per 24 hours and/or ≥50% reduction in micturition/catheterization frequency per 24 hours in patients with neurogenic overactive bladder (OAB) * Reduction of post void residual (PVR) below 25% of bladder capacity if bladder capacity * 100 mL, or below 50% of bladder capacity if bladder capacity <100 mL in patients with neurogenic voiding dysfunction * In patients with combined neurogenic OAB and neurogenic voiding dysfunction: The success criteria of leading symptom/dysfunction will be chosen
22 secondary outcomes
Volumetric changes during urodynamics and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Changes in bladder compliance [mL/cmH2O] during urodynamics and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Pressure changes during urodynamics and their relation to clinical outcomes
Time frame: Baseline; study week 1-8 / study end
Changes in maximum flow rate [mL/s] as assessed by urodynamics and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Changes in vesicoureterorenal reflux (VUR) as assessed by videography during urodynamics and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Changes in pelvic floor activity as assessed by electromyography (EMG) during urodynamics and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Changes in bladder storage and voiding parameters and their relation to clinical outcomes
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in bowel diary parameters and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Goal attainment scaling assessed by a self-assessment goal achievement (SAGA) questionnaire
Time frame: Baseline; study week 8 / study end
Changes in International Prostate Symptom (IPSS) questionnaire and their relation to clinical outcomes
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in urinary symptoms as assessed by the Urinary Symptom Profile (USP) questionnaire and their relation to clinical outcomes
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in Qualiveen questionnaire scores and their relation to clinical outcomes
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in Female Sexual Function Index (FSFI) and their relation to clinical outcomes
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in International Index of Erectile Function (IIEF) and their relation to clinical outcomes
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Variability and validity of University of South Australia Urinary Symptom Assessment questionnaire (USA2) for treatment follow-up
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in Neurogenic Bowel Dysfunction (NBD) questionnaire and their relation to clinical outcomes
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Changes in neurophysiology measurements of evoked potentials (EPs) as well as nerve conduction measurements and their relation to clinical outcomes
Time frame: Baseline; once per week during the TTNS intervention period; study week 8 / study end
Volumetric changes during rectal sensitivity testing and barostat assessment and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Pressure changes during anorectal manometry and barostat assessment and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Changes in rectal compliance [mL/cmH2O] during anorectal manometry and barostat assessment and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Changes in defecatory disorder [Rao's classification] identified during anorectal manometry and their relation to clinical outcomes
Time frame: Baseline; study week 8 / study end
Incidence of side effects as well as number and intensity/severity (mild/moderate/severe) of AEs and SAE
Time frame: During complete study period
Results and safety
The study was stopped early (reason given: Difficulties in recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 37204144Stalder SA, Gross O, Anderson CE, Bachmann LM, Baumann S, Birkhauser V, Bywater M, Del Popolo G, Engeler DS, Agro EF, Friedl S, Grilo N, Kiss S, Koschorke M, Leitner L, Liechti MD, Mehnert U, Musco S, Sadri H, Stachele L, Tornic J, van der Lely S, Wyler S, Kessler TM. bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction. BJU Int. 2023 Sep;132(3):343-352. doi: 10.1111/bju.16081. Epub 2023 Jun 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental TTNS in people with Neurogenic Bladder Dysfunction, run by University of Zurich at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Switzerland, Italy, Belgium, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in recruiting participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of TTNS (time frame: study week 8 / study end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04315142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.