Incontinence, UrgeNCT06247033
Evaluation of the Efficacy of Transcutaneous Tibial Nerve Stimulation on Post-Stroke Overactive Bladder
A study testing Tibial Nerve Stimulation with TENS device and Pelvic muscle training exercise with bladder training in people with Incontinence, Urge and Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to comparing the efficacies of different managements in patients with overactive bladder symptoms with stroke The main question it aims to answer are: Are pelvic floor training exercises and bladder training enough to ease the symptoms of overactive bladder in patients with stroke?… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incontinence, Urge, Stroke, Neurogenic Bladder
- What is being tested?
- Tibial Nerve Stimulation with TENS device and Pelvic muscle training exercise with bladder training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stroke patients who applied to our hospital with the illness interval of 6 months-24 months
- Cooperated patients with mini mental test 18 and above
- Patients who willing to be a participant
- Patients with scoring of OABSS 3 and above (at least 2 points must be gained from question 3.) will be evaluated with urodynamic study and only the patients with overactive detrusor findings during urodynamic study will be included.
Who cannot join
- Patients who not willing to be a participant
- Psychiatric or cognitive impairment, MMT < 18
- Spasticity that effects whole body, MAS 3 and above
- Urinary symptoms before stroke
- Global or sensorial aphasia
- Cardiac pacemaker
Show all 13Show fewer
- Urinary tract infection
- Benign prostate hypertrophy
- Already receiving any treatment because of neurogenic bladder
- History of botulinum toxin injection to the detrusor muscle
- Active malignancy
- Pregnants
- Post-void residue above 200 mL
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler PMR, Training and Research Hospital, Department of PMR
Ankara, Cankaya, 06100
About this study
The goal of this clinical trial is to comparing the efficacies of different managements in patients with overactive bladder symptoms with stroke
The main question it aims to answer are:
Read more
- Are pelvic floor training exercises and bladder training enough to ease the symptoms of overactive bladder in patients with stroke?
- Is tibial nerve stimulation really effective and does it decrease the need of medications in patients with overactive bladder with stroke? Participants are questioned if they have the symptoms of overactive bladder. After urodynamic evaluation, they are separated in 2 groups. Pelvic floor training exercises and bladder training are given in both groups; while one of the groups is followed with tibial nerve stimulation and the other one is followed with sham tibial nerve stimulation for 6 weeks.
Our main aim was to compare effectiveness of tibial nerve stimulation in patiens with overactive bladder with stroke.
Read the detailed description
A sham-controlled double-blinded randomized study was undertaken. 28 patients with chronic stroke were randomized into 2 groups. Pelvic floor training exercises and bladder training are given in both groups; while one of the groups is followed with tibial nerve stimulation and the other one is followed with sham tibial nerve stimulation for 6 weeks.
In both groups, patients are followed for completing the standart schedule of PFTE and BT; and excluded from our study if their rates below %80 according to exercise and training schedule.
Study group was followed with tibial nerve stimulation for 6 weeks, 2 sessions in a week, for 30 minutes. Stimulation was performed with TENS device, with settings of 10 Hz frequency, 200 msn wavelenght, continuous symetrical biphasic current. Amptlitude was increased just below the motor range that cause flexion in toes.
Control group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut off. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes.
After 6 weeks, both groups were evaluated with urodynamic study for the second time.
ICIQ-SF, King's Health Questionaire, Overactive Bladder Syndrome Symptom Scoring and urodynamic study parameters were examined in both pre- and post-treatment period.
Results were compared to see if there is any difference in the patients who followed with TNS and also pre-post treatment symptoms with PFTE and BT.
- Conditions
- Incontinence, Urge, Stroke, Neurogenic Bladder
- Being tested
- Tibial Nerve Stimulation with TENS device, Pelvic muscle training exercise with bladder training
- Medical subject headings
- Urinary Incontinence, Urge, Stroke, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial Nerve Stimulation with TENS deviceDevice
Tibial nerve stimulation was applied with TENS device transcutaneously and electrodes were positioned in medial part of the ankle. Negative transcutaneous electrode was positioned 3 centimeter posteriorly to the medial malleol. And positive transcutaneous electrode was positioned 10 centimeter above the negative electrode.
Pelvic muscle training exercise with bladder trainingBehavioural
Control group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut off. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes. All patients were followed for PFTE and BT according to given standard schedule.
| Study group | Role | What they receive |
|---|---|---|
| Active TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, TNS | Active comparator | Study group was followed with tibial nerve stimulation for 6 weeks, 2 sessions in a week, for 30 minutes. Stimulation was performed with TENS device, with settings of 10 Hz frequency, 200 msn wavelenght, continuous symetrical biphasic current. Amptlitude was increased just below the motor range that cause flexion in toes. All patiens were followed for PFTE and BT according to standard schedule. Receives: Device: Tibial Nerve Stimulation with TENS device |
| Sham TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, Sham TNS | Sham comparator | Control group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut down. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes. All patients were followed for PFTE and BT according to given standard schedule. Receives: Behavioral: Pelvic muscle training exercise with bladder training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urodynamic Study Parameters
Maximum Cystometric Capacity (mL)
Measured: 6 weeks
Overactive Bladder Symptom Scoring
A validated symptom scoring to detect the patients with overactive bladder symptoms and classifying them as low/moderate/high OABS. Higher results mean worse outcome
Measured: 6 weeks
Secondary outcomes (2)
ICIQ-SF
a subjective measure of severity of urinary loss and quality of life for those with urinary incontinence. Higher results mean worse outcome.
Measured: 6 weeks
King's Health Questionaire
Subjective measure of severity of urinary incontinence consists of nine domains: two single-item domains (general health perceptions and incontinence impact), and seven multi-item domains (role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity/coping. Higher results mean worse outcome
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, UrgeStudies of the same condition, open and under way.
- 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, Care provider, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umay Ekinci, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- Umay Ekinci, MD, Principal investigator, University of Health Sciences, Department of PM&R
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247033
- Sponsor's protocol ID
- 42
- Status last verified
- Jan 2024
- First submitted
- 21 Jan 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Transcutaneous Tibial Nerve Stimulation on Post-Stroke Overactive Bladder
- ClinicalTrials.gov ID
- NCT06247033
- Acronym / sponsor ID
- 42
- Conditions
- Incontinence, Urge, Stroke, Neurogenic Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 7 Feb 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 goal of this clinical trial is to comparing the efficacies of different managements in patients with overactive bladder symptoms with stroke
The main question it aims to answer are:
- Are pelvic floor training exercises and bladder training enough to ease the symptoms of overactive bladder in patients with stroke?
- Is tibial nerve stimulation really effective and does it decrease the need of medications in patients with overactive bladder with stroke? Participants are questioned if they have the symptoms of overactive bladder. After urodynamic evaluation, they are separated in 2 groups. Pelvic floor training exercises and bladder training are given in both groups; while one of the groups is followed with tibial nerve stimulation and the other one is followed with sham tibial nerve stimulation for 6 weeks.
Our main aim was to compare effectiveness of tibial nerve stimulation in patiens with overactive bladder with stroke.
Detailed description
A sham-controlled double-blinded randomized study was undertaken. 28 patients with chronic stroke were randomized into 2 groups. Pelvic floor training exercises and bladder training are given in both groups; while one of the groups is followed with tibial nerve stimulation and the other one is followed with sham tibial nerve stimulation for 6 weeks.
In both groups, patients are followed for completing the standart schedule of PFTE and BT; and excluded from our study if their rates below %80 according to exercise and training schedule.
Study group was followed with tibial nerve stimulation for 6 weeks, 2 sessions in a week, for 30 minutes. Stimulation was performed with TENS device, with settings of 10 Hz frequency, 200 msn wavelenght, continuous symetrical biphasic current. Amptlitude was increased just below the motor range that cause flexion in toes.
Control group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut off. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes.
After 6 weeks, both groups were evaluated with urodynamic study for the second time.
ICIQ-SF, King's Health Questionaire, Overactive Bladder Syndrome Symptom Scoring and urodynamic study parameters were examined in both pre- and post-treatment period.
Results were compared to see if there is any difference in the patients who followed with TNS and also pre-post treatment symptoms with PFTE and BT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, TNS | Active comparator | Device: Tibial Nerve Stimulation with TENS deviceStudy group was followed with tibial nerve stimulation for 6 weeks, 2 sessions in a week, for 30 minutes. Stimulation was performed with TENS device, with settings of 10 Hz frequency, 200 msn wavelenght, continuous symetrical biphasic current. Amptlitude was increased just below the motor range that cause flexion in toes. All patiens were followed for PFTE and BT according to standard schedule. |
| Sham TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, Sham TNS | Sham comparator | Behavioral: Pelvic muscle training exercise with bladder trainingControl group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut down. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes. All patients were followed for PFTE and BT according to given standard schedule. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke patients who applied to our hospital with the illness interval of 6 months-24 months
- Cooperated patients with mini mental test 18 and above
- Patients who willing to be a participant
- Patients with scoring of OABSS 3 and above (at least 2 points must be gained from question 3.) will be evaluated with urodynamic study and only the patients with overactive detrusor findings during urodynamic study will be included.
Key exclusion criteria (13 listed)
- Patients who not willing to be a participant
- Psychiatric or cognitive impairment, MMT < 18
- Spasticity that effects whole body, MAS 3 and above
- Urinary symptoms before stroke
- Global or sensorial aphasia
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 |
|---|---|---|
| Tibial Nerve Stimulation with TENS deviceTibial nerve stimulation was applied with TENS device transcutaneously and electrodes were positioned in medial part of the ankle. Negative transcutaneous electrode was positioned 3 centimeter posteriorly to the medial malleol. And positive transcutaneous electrode was positioned 10 centimeter above the negative electrode. | Device | Active TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, TNS |
| Pelvic muscle training exercise with bladder trainingControl group was followed with sham tibial nerve stimulation, which were performed by after starting electric current with TENS device, current were decreased and completely shut off. Sham stimulation was also applied for 6 weeks, 2 times in a week, 30 minutes. All patients were followed for PFTE and BT according to given standard schedule. | Behavioural | Sham TNS - Chronic stroke patients with urgency symptoms, followed with PFTE, BT, Sham TNS |
Primary outcome
Urodynamic Study Parameters
Time frame: 6 weeks
Maximum Cystometric Capacity (mL)
Overactive Bladder Symptom Scoring
Time frame: 6 weeks
A validated symptom scoring to detect the patients with overactive bladder symptoms and classifying them as low/moderate/high OABS. Higher results mean worse outcome
2 secondary outcomes
ICIQ-SF
Time frame: 6 weeks
King's Health Questionaire
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- 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.
Umay Ekinci, MD principal investigator
University of Health Sciences, Department of PM&R
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibial Nerve Stimulation with TENS device and Pelvic muscle training exercise with bladder training in people with Incontinence, Urge and Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 14 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urodynamic Study Parameters (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.