Overactive Bladder (OAB)NCT07788560
Peroneal Neuromodulation vs Pelvic Floor Exercises in OAB
A study testing Transcutaneous Peroneal Electrical Neuromodulation and Pelvic Floor Exercise in people with Overactive Bladder (OAB) and Neuromodulation, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Overactive bladder (OAB) is a common condition characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency urinary incontinence. Several non-invasive treatment options are available, including pelvic floor exercises and neuromodulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder (OAB), Neuromodulation
- What is being tested?
- Transcutaneous Peroneal Electrical Neuromodulation and Pelvic Floor Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 years or older.
- Diagnosis of idiopathic overactive bladder (OAB) based on clinical evaluation.
- Presence of urinary urgency, with or without urgency urinary incontinence, usually accompanied by increased urinary frequency and/or nocturia.
- OAB symptoms present for at least 3 months.
- Ability to complete bladder diaries and symptom questionnaires.
- Willingness to participate in the study and provide written informed consent.
- Ability to comply with the assigned treatment protocol and scheduled follow-up visits.
Who cannot join
- Neurogenic lower urinary tract dysfunction or a known neurological disease affecting bladder function.
- Active urinary tract infection at the time of enrollment.
- Significant pelvic organ prolapse.
- Predominant stress urinary incontinence or mixed urinary incontinence with predominant stress symptoms.
- Clinically significant bladder outlet obstruction or urinary retention.
- History of major pelvic surgery or pelvic radiotherapy that may affect lower urinary tract function.
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- Previous treatment with botulinum toxin injection or neuromodulation within the predefined washout period.
- Current use of OAB medications that cannot be discontinued or appropriately washed out before enrollment.
- Pregnancy.
- Presence of a cardiac pacemaker, implanted defibrillator, or another implanted electrical device incompatible with electrical stimulation.
- Any condition that, in the investigator's judgment, would prevent safe participation or adherence to the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara University School of Medicine Urology Department
Istanbul, Pendik, 34854
Tarik Emre Sener, 05344525700, dr.emresener@gmail.com
About this study
Official title: Comparison of the Efficacy of Transcutaneous Peroneal Electrical Neuromodulation and Pelvic Floor Exercises in the Treatment of Idiopathic Overactive Bladder
Overactive bladder (OAB) is a common condition characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency urinary incontinence. Several non-invasive treatment options are available, including pelvic floor exercises and neuromodulation.
This prospective, randomized study aims to compare the effectiveness and safety of transcutaneous peroneal electrical neuromodulation and pelvic floor exercises in adults with idiopathic OAB. Participants will be randomly assigned in a 1:1 ratio to receive either transcutaneous peroneal neuromodulation or pelvic floor exercise therapy for 3 months.
Treatment outcomes will be assessed using bladder diary parameters and OAB symptom scores at baseline and at 1 and 3 months after treatment initiation. Treatment adherence and treatment-related adverse events will also be evaluated. The study aims to determine whether transcutaneous peroneal neuromodulation provides comparable or improved clinical outcomes compared with pelvic floor exercises in patients with idiopathic OAB.
- Conditions
- Overactive Bladder (OAB), Neuromodulation
- Being tested
- Transcutaneous Peroneal Electrical Neuromodulation, Pelvic Floor Exercise
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Peroneal Electrical NeuromodulationDevice
Transcutaneous peroneal electrical neuromodulation will be administered once weekly for 3 months. Each treatment session will last 30 minutes. Electrical stimulation will be delivered transcutaneously over the peroneal nerve using surface electrodes.
Pelvic Floor ExerciseBehavioural
Participants will undergo pelvic floor muscle training for 3 months according to a standardized exercise protocol. The exercises will be taught and supervised by the same trained physiotherapist to ensure standardized treatment across participants.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous peroneal electrical neuromodulation | Active comparator | Participants assigned to this arm will receive transcutaneous peroneal electrical neuromodulation for 3 months. Neuromodulation will be administered in 30-minute sessions once weekly. Receives: Device: Transcutaneous Peroneal Electrical Neuromodulation |
| Pelvic Floor Exercises | Active comparator | Participants assigned to this arm will receive pelvic floor exercise therapy for 3 months. The exercises will be performed according to a standardized protocol under the guidance of the same physiotherapist. Receives: Behavioral: Pelvic Floor Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overactive Bladder Symptom Score from baseline to 3 months
The change in overactive bladder symptom severity will be assessed using the validated Overactive Bladder Questionnaire (OAB-V8). Scores will be recorded at baseline and at 3 months after initiation of treatment. A greater reduction in score indicates greater improvement in overactive bladder symptoms.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- More trials run by Marmara 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Emre Sener, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788560
- Sponsor's protocol ID
- MAR.UAD.0036
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Transcutaneous Peroneal Electrical Neuromodulation and Pelvic Floor Exercises in the Treatment of Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT07788560
- Acronym / sponsor ID
- MAR.UAD.0036
- Conditions
- Overactive Bladder (OAB), Neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 26 Aug 2026 (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.
Overactive bladder (OAB) is a common condition characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency urinary incontinence. Several non-invasive treatment options are available, including pelvic floor exercises and neuromodulation.
This prospective, randomized study aims to compare the effectiveness and safety of transcutaneous peroneal electrical neuromodulation and pelvic floor exercises in adults with idiopathic OAB. Participants will be randomly assigned in a 1:1 ratio to receive either transcutaneous peroneal neuromodulation or pelvic floor exercise therapy for 3 months.
Treatment outcomes will be assessed using bladder diary parameters and OAB symptom scores at baseline and at 1 and 3 months after treatment initiation. Treatment adherence and treatment-related adverse events will also be evaluated. The study aims to determine whether transcutaneous peroneal neuromodulation provides comparable or improved clinical outcomes compared with pelvic floor exercises in patients with idiopathic OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous peroneal electrical neuromodulation | Active comparator | Device: Transcutaneous Peroneal Electrical NeuromodulationParticipants assigned to this arm will receive transcutaneous peroneal electrical neuromodulation for 3 months. Neuromodulation will be administered in 30-minute sessions once weekly. |
| Pelvic Floor Exercises | Active comparator | Behavioral: Pelvic Floor ExerciseParticipants assigned to this arm will receive pelvic floor exercise therapy for 3 months. The exercises will be performed according to a standardized protocol under the guidance of the same physiotherapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older.
- Diagnosis of idiopathic overactive bladder (OAB) based on clinical evaluation.
- Presence of urinary urgency, with or without urgency urinary incontinence, usually accompanied by increased urinary frequency and/or nocturia.
- OAB symptoms present for at least 3 months.
- Ability to complete bladder diaries and symptom questionnaires.
Key exclusion criteria (11 listed)
- Neurogenic lower urinary tract dysfunction or a known neurological disease affecting bladder function.
- Active urinary tract infection at the time of enrollment.
- Significant pelvic organ prolapse.
- Predominant stress urinary incontinence or mixed urinary incontinence with predominant stress symptoms.
- Clinically significant bladder outlet obstruction or urinary retention.
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 Peroneal Electrical NeuromodulationTranscutaneous peroneal electrical neuromodulation will be administered once weekly for 3 months. Each treatment session will last 30 minutes. Electrical stimulation will be delivered transcutaneously over the peroneal nerve using surface electrodes. | Device | Transcutaneous peroneal electrical neuromodulation |
| Pelvic Floor ExerciseParticipants will undergo pelvic floor muscle training for 3 months according to a standardized exercise protocol. The exercises will be taught and supervised by the same trained physiotherapist to ensure standardized treatment across participants. | Behavioural | Pelvic Floor Exercises |
Primary outcome
Change in Overactive Bladder Symptom Score from baseline to 3 months
Time frame: Baseline to 3 months
The change in overactive bladder symptom severity will be assessed using the validated Overactive Bladder Questionnaire (OAB-V8). Scores will be recorded at baseline and at 3 months after initiation of treatment. A greater reduction in score indicates greater improvement in overactive bladder symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Peroneal Electrical Neuromodulation and Pelvic Floor Exercise in people with Overactive Bladder (OAB) and Neuromodulation, run by Marmara 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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 26 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarik Emre Sener (05344525700, turkeraltuntas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overactive Bladder Symptom Score from baseline to 3 months (time frame: Baseline to 3 months). 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 26 Aug 2026.