Urinary Bladder, OveractiveNCT06385769
Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke
A study testing Transcutaneous tibial nerve stimulation (TTNS) in people with Urinary Bladder, Overactive, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Transcutaneous tibial nerve stimulation (TTNS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2024to 28 Feb 2026
- 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
- Patients aged 40 and above with stable ischemic or hemorrhagic stroke.
- Patients with neurogenic detrusor overactivity symptoms accompanied by urinary incontinence complaints and a urinary frequency of 9 or more.
- Patients diagnosed with detrusor overactivity on urodynamic evaluation.
- Patients with hemiplegia lasting between 30 days and 1 year.
- Ability to understand procedures, benefits, and potential side effects.
- Patients scoring 22 or above on the Mini Mental Test.
Who cannot join
- Patients with post-stroke neurogenic detrusor overactivity receiving or previously received pharmacological treatment.
- Patients using intermittent catheterization or permanent catheterization as a bladder emptying method.
- Patients with a history of urinary incontinence and/or urinary retention before stroke.
- History of past urogynecological surgery.
- Presence of urinary tract infection, bladder tumor, or cardiac pacemaker.
- Significant fluid infusion requirement affecting urination or use of medication affecting bladder function.
- Patients who have received botulinum toxin injection for post-stroke neurogenic detrusor overactivity.
- Patients with postvoid residual volume above 150 mL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke: A Randomized Placebo-controlled Clinical Trial.
The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.
The main questions aimed to be answered are:
What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week).
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Transcutaneous tibial nerve stimulation (TTNS), Sham Transcutaneous tibial nerve stimulation (TTNS)
- Keywords
- Overactive bladder after stroke, Transcutaneous tibial nerve stimulation, Urinary incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous tibial nerve stimulation (TTNS)Other
The TTNS will be conducted unilaterally, with the patient in a supine position, using a surface electrode dual stimulation channel stimulation device. Two self-adhesive round surface electrodes will be positioned with the negative electrode 2 cm behind the medial malleolus and the positive electrode 10 cm proximal to it. The ground electrode will be placed on the ipsilateral limb. Channel 1 will provide active stimulation, while channel 2 will remain inactive.
Sham Transcutaneous tibial nerve stimulation (TTNS)Other
Sham TTNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the TTNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous tibial nerve stimulation (TTNS) | Experimental | In this study, one channel of the stimulation device will provide active stimulation to the patient, while the second channel will not be connected. The patient won't know which channel is active. Both channels will use continuous mode with a pulse frequency of 20 Hz and a pulse width of 200 ms. The intensity for the active channel will be adjusted based on comfort level and observed hallux reaction. Treatment includes 20 sessions of 30 minutes each, administered five times a week for four weeks. Receives: Other: Transcutaneous tibial nerve stimulation (TTNS) |
| Sham Transcutaneous tibial nerve stimulation (TTNS) | Sham comparator | In the placebo group, the same electrotherapy device and settings as the active group will be used. One channel will not be connected to the patient but will display treatment details on the screen. The other channel will be connected but deliver no stimulation. Intensity for the inactive channel is limited to 2-3 mA. Patients will be informed that exceeding this threshold is prevented. Treatment includes 20 sessions of 30 minutes each, administered twice a week for four weeks. Receives: Other: Sham Transcutaneous tibial nerve stimulation (TTNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased frequency of increased voiding
The effectiveness of the treatment is evaluated based on the daily voiding frequency post-treatment compared to the daily voiding frequency pre-treatment. The expected outcome is a reduction in the frequency of increased voiding.
Measured: Change from baseline positive response rate at the 4th week after the treatment
Secondary outcomes (6)
Frequency of voiding
The frequency of voiding used will be calculated from the patient's 3-day voiding frequency.
Measured: Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment
The Quality of Life
The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence
Measured: Change from baseline the Quality of Life at the 4th week after the treatment
Barthel Index for Activities of Daily Living (ADL)
The Barthel Index assesses activities of daily living (ADLs), documenting what a patient does daily without determining capabilities. The 10 items to score are: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation, and stair climbing. Scores reflect independence, with lower scores indicating less independence. A score above 60 typically denotes independence.
Measured: Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment
The Overactive Bladder Symptom Score (OABSS)
OABSS (Overactive Bladder Symptom Score), four questions assessing daytime frequency (OABSS-1), nocturia frequency (OABSS-2), urgency frequency (OABSS-3), and urgency urinary incontinence (OABSS-4). Severity is rated on a Likert scale from 0-2, 0-3, 0-5, and 0-5, respectively. The total score ranges from 0 to 15, with higher scores indicating more severe symptoms.
Measured: Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment
Treatment Satisfaction Level
At the end of the treatment, participants will be asked to evaluate their satisfaction level with the administered treatment using a Likert scale ranging from 1 to 5 (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, 1=very dissatisfied).
Measured: Change from baseline Treatment Satisfaction Level at the 4th week after the treatment
Cystometric value
Cystometric value are useful in defining the voiding characteristics of patients.
Measured: Change from baseline Cystometric value at the 4th week after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start22 Apr 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmettin Yildiz, Pamukkale University
- Investigators
- Necmettin Yıldız, Prof., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385769
- Sponsor's protocol ID
- PamukkaleU.ftr-NYıldız-3
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas LH, Watkins CL, French B, Sutton C, Forshaw D, Cheater F, Roe B, Leathley MJ, Burton C, McColl E, Booth J; ICONS Project Team; ICONS Patient, Public and Carer Involvement Group. Study protocol: ICONS: identifying continence options after stroke: a randomised trial. Trials. 2011 May 20;12:131. doi: 10.1186/1745-6215-12-131.
PubMed 21599945Patel M, Coshall C, Rudd AG, Wolfe CD. Natural history and effects on 2-year outcomes of urinary incontinence after stroke. Stroke. 2001 Jan;32(1):122-7. doi: 10.1161/01.str.32.1.122.
PubMed 11136926Gross T, Schneider MP, Bachmann LM, Blok BF, Groen J, Hoen LA, Castro-Diaz D, Padilla Fernandez B, Del Popolo G, Musco S, Hamid R, Ecclestone H, Karsenty G, Phe V, Pannek J, Kessler TM. Transcutaneous Electrical Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review. Eur Urol. 2016 Jun;69(6):1102-11. doi: 10.1016/j.eururo.2016.01.010. Epub 2016 Jan 29.
PubMed 26831506Parittotokkaporn S, Varghese C, O'Grady G, Svirskis D, Subramanian S, O'Carroll SJ. Non-invasive neuromodulation for bowel, bladder and sexual restoration following spinal cord injury: A systematic review. Clin Neurol Neurosurg. 2020 Jul;194:105822. doi: 10.1016/j.clineuro.2020.105822. Epub 2020 Apr 12.
PubMed 32334284Hagerty JA, Richards I, Kaplan WE. Intravesical electrotherapy for neurogenic bladder dysfunction: a 22-year experience. J Urol. 2007 Oct;178(4 Pt 2):1680-3; discussion 1683. doi: 10.1016/j.juro.2007.03.188. Epub 2007 Aug 17.
PubMed 17707024Nardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.
PubMed 31541980Araujo TG, Schmidt AP, Sanches PRS, Silva Junior DP, Rieder CRM, Ramos JGL. Transcutaneous tibial nerve home stimulation for overactive bladder in women with Parkinson's disease: A randomized clinical trial. Neurourol Urodyn. 2021 Jan;40(1):538-548. doi: 10.1002/nau.24595. Epub 2020 Dec 16.
PubMed 33326648Perissinotto MC, D'Ancona CA, Lucio A, Campos RM, Abreu A. Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with Parkinson disease: a randomized controlled trial. J Wound Ostomy Continence Nurs. 2015 Jan-Feb;42(1):94-9. doi: 10.1097/WON.0000000000000078.
PubMed 25549314Gaspard L, Tombal B, Opsomer RJ, Castille Y, Van Pesch V, Detrembleur C. [Physiotherapy and neurogenic lower urinary tract dysfunction in multiple sclerosis patients: a randomized controlled trial]. Prog Urol. 2014 Sep;24(11):697-707. doi: 10.1016/j.purol.2014.05.003. Epub 2014 Jun 19. French.
PubMed 25214451Zonic-Imamovic M, Imamovic S, Cickusic A, Delalic A, Hodzic R, Imamovic M. Effects of Treating an Overactive Urinary Bladder in Patients with Multiple Sclerosis. Acta Med Acad. 2019 Dec;48(3):271-277. doi: 10.5644/ama2006-124.267.
PubMed 32124625Eftekhar T, Teimoory N, Miri E, Nikfallah A, Naeimi M, Ghajarzadeh M. Posterior tibial nerve stimulation for treating neurologic bladder in women: a randomized clinical trial. Acta Med Iran. 2014;52(11):816-21.
PubMed 25415813Monteiro ES, de Carvalho LB, Fukujima MM, Lora MI, do Prado GF. Electrical stimulation of the posterior tibialis nerve improves symptoms of poststroke neurogenic overactive bladder in men: a randomized controlled trial. Urology. 2014 Sep;84(3):509-14. doi: 10.1016/j.urology.2014.05.031.
PubMed 25168524Liu Y, Xu G, Luo M, Teng HF. Effects of Transcutaneous Electrical Nerve Stimulation at Two Frequencies on Urinary Incontinence in Poststroke Patients: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2016 Mar;95(3):183-93. doi: 10.1097/PHM.0000000000000360.
PubMed 26259053Erden E, Ersoz M, Erden E, Tiftik T. Urodynamic findings and therapeutic approaches for neurogenic lower urinary tract dysfunction in patients with thoracic spinal cord injury. Ir J Med Sci. 2023 Oct;192(5):2513-2520. doi: 10.1007/s11845-022-03239-9. Epub 2022 Dec 1.
PubMed 36454536Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.
PubMed 23206722
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke: A Randomized Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06385769
- Acronym / sponsor ID
- PamukkaleU.ftr-NYıldız-3
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive bladder after stroke, Transcutaneous tibial nerve stimulation, Urinary incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 26 Apr 2024 (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.
The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.
The main questions aimed to be answered are:
What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week).
Study design
- Primary purpose
- Other
- 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 | Other: Transcutaneous tibial nerve stimulation (TTNS)In this study, one channel of the stimulation device will provide active stimulation to the patient, while the second channel will not be connected. The patient won't know which channel is active. Both channels will use continuous mode with a pulse frequency of 20 Hz and a pulse width of 200 ms. The intensity for the active channel will be adjusted based on comfort level and observed hallux reaction. Treatment includes 20 sessions of 30 minutes each, administered five times a week for four weeks. |
| Sham Transcutaneous tibial nerve stimulation (TTNS) | Sham comparator | Other: Sham Transcutaneous tibial nerve stimulation (TTNS)In the placebo group, the same electrotherapy device and settings as the active group will be used. One channel will not be connected to the patient but will display treatment details on the screen. The other channel will be connected but deliver no stimulation. Intensity for the inactive channel is limited to 2-3 mA. Patients will be informed that exceeding this threshold is prevented. Treatment includes 20 sessions of 30 minutes each, administered twice a week for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 40 and above with stable ischemic or hemorrhagic stroke.
- Patients with neurogenic detrusor overactivity symptoms accompanied by urinary incontinence complaints and a urinary frequency of 9 or more.
- Patients diagnosed with detrusor overactivity on urodynamic evaluation.
- Patients with hemiplegia lasting between 30 days and 1 year.
- Ability to understand procedures, benefits, and potential side effects.
Key exclusion criteria (8 listed)
- Patients with post-stroke neurogenic detrusor overactivity receiving or previously received pharmacological treatment.
- Patients using intermittent catheterization or permanent catheterization as a bladder emptying method.
- Patients with a history of urinary incontinence and/or urinary retention before stroke.
- History of past urogynecological surgery.
- Presence of urinary tract infection, bladder tumor, or cardiac pacemaker.
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 |
|---|---|---|
| Transcutaneous tibial nerve stimulation (TTNS)The TTNS will be conducted unilaterally, with the patient in a supine position, using a surface electrode dual stimulation channel stimulation device. Two self-adhesive round surface electrodes will be positioned with the negative electrode 2 cm behind the medial malleolus and the positive electrode 10 cm proximal to it. The ground electrode will be placed on the ipsilateral limb. Channel 1 will provide active stimulation, while channel 2 will remain inactive. | Other | Transcutaneous tibial nerve stimulation (TTNS) |
| Sham Transcutaneous tibial nerve stimulation (TTNS)Sham TTNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the TTNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation. | Other | Sham Transcutaneous tibial nerve stimulation (TTNS) |
Primary outcome
Decreased frequency of increased voiding
Time frame: Change from baseline positive response rate at the 4th week after the treatment
The effectiveness of the treatment is evaluated based on the daily voiding frequency post-treatment compared to the daily voiding frequency pre-treatment. The expected outcome is a reduction in the frequency of increased voiding.
6 secondary outcomes
Frequency of voiding
Time frame: Change from baseline Frequency of voiding, nocturia, number of pads at the 4th week after the treatment
The Quality of Life
Time frame: Change from baseline the Quality of Life at the 4th week after the treatment
Barthel Index for Activities of Daily Living (ADL)
Time frame: Change from baseline Barthel Index for Activities of Daily Living at the 4th week after the treatment
The Overactive Bladder Symptom Score (OABSS)
Time frame: Change from baseline The Overactive Bladder Symptom Score at the 4th week after the treatment
Treatment Satisfaction Level
Time frame: Change from baseline Treatment Satisfaction Level at the 4th week after the treatment
Cystometric value
Time frame: Change from baseline Cystometric value at the 4th week after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Background: PubMed 21599945Thomas LH, Watkins CL, French B, Sutton C, Forshaw D, Cheater F, Roe B, Leathley MJ, Burton C, McColl E, Booth J; ICONS Project Team; ICONS Patient, Public and Carer Involvement Group. Study protocol: ICONS: identifying continence options after stroke: a randomised trial. Trials. 2011 May 20;12:131. doi: 10.1186/1745-6215-12-131.
- Background: PubMed 11136926Patel M, Coshall C, Rudd AG, Wolfe CD. Natural history and effects on 2-year outcomes of urinary incontinence after stroke. Stroke. 2001 Jan;32(1):122-7. doi: 10.1161/01.str.32.1.122.
- Background: PubMed 26831506Gross T, Schneider MP, Bachmann LM, Blok BF, Groen J, Hoen LA, Castro-Diaz D, Padilla Fernandez B, Del Popolo G, Musco S, Hamid R, Ecclestone H, Karsenty G, Phe V, Pannek J, Kessler TM. Transcutaneous Electrical Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review. Eur Urol. 2016 Jun;69(6):1102-11. doi: 10.1016/j.eururo.2016.01.010. Epub 2016 Jan 29.
- Background: PubMed 32334284Parittotokkaporn S, Varghese C, O'Grady G, Svirskis D, Subramanian S, O'Carroll SJ. Non-invasive neuromodulation for bowel, bladder and sexual restoration following spinal cord injury: A systematic review. Clin Neurol Neurosurg. 2020 Jul;194:105822. doi: 10.1016/j.clineuro.2020.105822. Epub 2020 Apr 12.
- Background: PubMed 17707024Hagerty JA, Richards I, Kaplan WE. Intravesical electrotherapy for neurogenic bladder dysfunction: a 22-year experience. J Urol. 2007 Oct;178(4 Pt 2):1680-3; discussion 1683. doi: 10.1016/j.juro.2007.03.188. Epub 2007 Aug 17.
- Background: PubMed 31541980Nardone R, Versace V, Sebastianelli L, Brigo F, Golaszewski S, Christova M, Saltuari L, Trinka E. Transcranial magnetic stimulation and bladder function: A systematic review. Clin Neurophysiol. 2019 Nov;130(11):2032-2037. doi: 10.1016/j.clinph.2019.08.020. Epub 2019 Sep 3.
- Background: PubMed 33326648Araujo TG, Schmidt AP, Sanches PRS, Silva Junior DP, Rieder CRM, Ramos JGL. Transcutaneous tibial nerve home stimulation for overactive bladder in women with Parkinson's disease: A randomized clinical trial. Neurourol Urodyn. 2021 Jan;40(1):538-548. doi: 10.1002/nau.24595. Epub 2020 Dec 16.
- Background: PubMed 25549314Perissinotto MC, D'Ancona CA, Lucio A, Campos RM, Abreu A. Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with Parkinson disease: a randomized controlled trial. J Wound Ostomy Continence Nurs. 2015 Jan-Feb;42(1):94-9. doi: 10.1097/WON.0000000000000078.
- Background: PubMed 25214451Gaspard L, Tombal B, Opsomer RJ, Castille Y, Van Pesch V, Detrembleur C. [Physiotherapy and neurogenic lower urinary tract dysfunction in multiple sclerosis patients: a randomized controlled trial]. Prog Urol. 2014 Sep;24(11):697-707. doi: 10.1016/j.purol.2014.05.003. Epub 2014 Jun 19. French.
- Background: PubMed 32124625Zonic-Imamovic M, Imamovic S, Cickusic A, Delalic A, Hodzic R, Imamovic M. Effects of Treating an Overactive Urinary Bladder in Patients with Multiple Sclerosis. Acta Med Acad. 2019 Dec;48(3):271-277. doi: 10.5644/ama2006-124.267.
- Background: PubMed 25415813Eftekhar T, Teimoory N, Miri E, Nikfallah A, Naeimi M, Ghajarzadeh M. Posterior tibial nerve stimulation for treating neurologic bladder in women: a randomized clinical trial. Acta Med Iran. 2014;52(11):816-21.
- Background: PubMed 25168524Monteiro ES, de Carvalho LB, Fukujima MM, Lora MI, do Prado GF. Electrical stimulation of the posterior tibialis nerve improves symptoms of poststroke neurogenic overactive bladder in men: a randomized controlled trial. Urology. 2014 Sep;84(3):509-14. doi: 10.1016/j.urology.2014.05.031.
- Individual participant dataSharing planned: No
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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.
Necmettin Yıldız, Prof. study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous tibial nerve stimulation (TTNS) in people with Urinary Bladder, Overactive, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emre Bezmez, M.D. (+905319902220, emrebezmez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased frequency of increased voiding (time frame: Change from baseline positive response rate at the 4th week after the treatment). 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 NCT06385769, which also lists 20 linked publications.
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 26 Apr 2024.