Overactive Bladder (OAB)NCT07728747
Bladder Training With or Without Biofeedback-Assisted Pelvic Floor Muscle Training for Women With Wet Overactive Bladder
A study testing Bladder Training and EMG Biofeedback-Assisted Pelvic Floor Muscle Training in people with Overactive Bladder (OAB) and Detrusor Overactivity, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
Trial summary
Overactive bladder causes a sudden and difficult-to-control need to urinate and may be accompanied by urine leakage. Bladder training is commonly used as a first-line treatment. Pelvic floor muscle training supported by electromyographic biofeedback may help women recognize and contract the correct muscles and improve… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Overactive Bladder (OAB), Detrusor Overactivity, Urgency Urinary Incontinence
- What is being tested?
- Bladder Training and EMG Biofeedback-Assisted Pelvic Floor Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 1 Apr 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years or older
- Presence of wet overactive bladder symptoms
- Detrusor overactivity confirmed by urodynamic testing
- Pelvic floor muscle strength of at least 3/5 according to the Modified Oxford Scale
- Ability to comply with the study procedures and complete the bladder diary
Who cannot join
- Neurogenic bladder
- Active urinary tract infection or vulvovaginitis
- Pregnancy or planning pregnancy
- Urogynecological surgery within the previous 3 months
- Pelvic organ prolapse stage 2 or higher according to the Pelvic Organ Prolapse Quantification system
- Presence of a pacemaker or implantable defibrillator
- Recent conservative or pharmacological treatment for overactive bladder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SANKO University Sani Konukoglu Application and Research Hospital
Gaziantep, Şahinbey, 27010
About this study
Official title: Adjunctive EMG Biofeedback-Assisted Pelvic Floor Muscle Training in Women With Wet Overactive Bladder and Urodynamically Confirmed Detrusor Overactivity: A Randomized Controlled Trial
Overactive bladder causes a sudden and difficult-to-control need to urinate and may be accompanied by urine leakage. Bladder training is commonly used as a first-line treatment. Pelvic floor muscle training supported by electromyographic biofeedback may help women recognize and contract the correct muscles and improve control of urgency and leakage.
The purpose of this randomized controlled trial was to determine whether adding electromyographic biofeedback-assisted pelvic floor muscle training to bladder training provides additional benefit compared with bladder training alone in women with wet overactive bladder and urodynamically confirmed detrusor overactivity.
Read more
A total of 64 women were randomly assigned in a 1:1 ratio to receive either bladder training alone or bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training. Both interventions lasted 8 weeks. Participants in the combined intervention group received 24 supervised biofeedback sessions in addition to bladder training.
The primary outcome was the change in daily voiding frequency measured using a 3-day bladder diary. Secondary outcomes included urgency, urgency urinary incontinence, nocturia, incontinence-related quality of life, pelvic floor muscle function, treatment adherence, treatment satisfaction, and adverse events. Outcomes were assessed at baseline and at week 8.
Read the detailed description
This was an assessor-blinded, two-arm, parallel-group randomized controlled trial conducted in women with wet overactive bladder and urodynamically confirmed detrusor overactivity.
Eligible participants were randomly assigned in a 1:1 ratio to a bladder training group or a bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training group. All participants received an 8-week bladder training program that included education, counseling on fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies.
Participants assigned to the combined intervention additionally received 24 individually supervised electromyographic biofeedback-assisted pelvic floor muscle training sessions over 8 weeks. Surface perineal electrodes were used to provide visual feedback during pelvic floor muscle contractions. Training included slow and fast pelvic floor muscle contractions under the supervision of the same physiotherapist.
Assessments were performed at baseline and at week 8. The primary outcome was the change in mean daily voiding frequency calculated from a 3-day bladder diary. Secondary outcomes included daily urgency episodes, urgency urinary incontinence episodes, nocturia episodes, daily fluid intake, incontinence-related quality of life, the impact of urinary incontinence on daily activities, pelvic floor muscle strength, treatment satisfaction, intervention adherence, and adverse events.
The urologist performing the follow-up outcome assessments was blinded to treatment allocation. Participants and the treating physiotherapist could not be blinded because of the nature of the intervention.
- Being tested
- Bladder Training, EMG Biofeedback-Assisted Pelvic Floor Muscle Training
- Keywords
- Wet Overactive Bladder, Bladder Training, Pelvic Floor Muscle Training, Electromyographic Biofeedback, Urodynamics, Conservative Treatment
- 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.
Bladder TrainingBehavioural
An 8-week bladder training program including education on lower urinary tract anatomy and overactive bladder, counseling regarding fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies. Voiding intervals were individualized according to the baseline bladder diary and gradually increased according to participant tolerance.
EMG Biofeedback-Assisted Pelvic Floor Muscle TrainingBehavioural
An 8-week individually supervised pelvic floor muscle training program using surface electromyographic biofeedback. Participants received three sessions per week for a total of 24 sessions. Surface perineal electrodes provided visual feedback during isolated pelvic floor muscle contractions. Each session included 40 slow contractions consisting of 10 seconds of contraction and 20 seconds of relaxation, followed by five sets of 10 fast contractions consisting of 1 second of contraction and 2 seconds of relaxation, with 2-minute rest periods between sets.
| Study group | Role | What they receive |
|---|---|---|
| Bladder Training | Active comparator | Participants assigned to this arm received an 8-week bladder training program including education, counseling on fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies. Receives: Behavioral: Bladder Training |
| Bladder Training Plus EMG Biofeedback-Assisted Pelvic Floor Muscle Training | Experimental | Participants assigned to this arm received the same 8-week bladder training program plus 24 individually supervised electromyographic biofeedback-assisted pelvic floor muscle training sessions delivered three times per week. Receives: Behavioral: Bladder Training; Behavioral: EMG Biofeedback-Assisted Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Daily Voiding Frequency
Mean daily voiding frequency was calculated as the mean number of voids per day recorded in a 3-day bladder diary. Change was calculated as the week-8 value minus the baseline value. Negative change values indicate a reduction in daily voiding frequency.
Measured: Baseline and week 8
Secondary outcomes (13)
Change From Baseline in Mean Daily Urgency Episodes
The mean number of urgency episodes per day was calculated from a 3-day bladder diary. Change was calculated as the week-8 value minus the baseline value. Negative change values indicate a reduction in urgency episodes.
Measured: Baseline and week 8
Change From Baseline in Mean Daily Urgency Urinary Incontinence Episodes
The mean number of urgency urinary incontinence episodes per day was calculated from a 3-day bladder diary. Change was calculated as the week-8 value minus the baseline value. Negative change values indicate a reduction in urgency urinary incontinence episodes.
Measured: Baseline and week 8
Change From Baseline in Mean Nightly Nocturia Episodes
The mean number of nocturia episodes per night was calculated from a 3-day bladder diary. Change was calculated as the week-8 value minus the baseline value. Negative change values indicate a reduction in nocturia episodes.
Measured: Baseline and week 8
Change From Baseline in Mean Daily Fluid Intake
Mean daily fluid intake was calculated in milliliters per day from a 3-day bladder diary. Change was calculated as the week-8 value minus the baseline value.
Measured: Baseline and week 8
Change From Baseline in Incontinence Quality of Life Questionnaire Total Score
Incontinence-related quality of life was assessed using the 22-item Incontinence Quality of Life Questionnaire. Total scores were transformed to a 0-to-100 scale, with higher scores indicating better quality of life. Change was calculated as the week-8 score minus the baseline score. Positive change values indicate improvement.
Measured: Baseline and week 8
Change From Baseline in Incontinence Impact Questionnaire-7 Total Score
The impact of urinary incontinence on daily life was assessed using the 7-item Incontinence Impact Questionnaire-7. Total scores were transformed to a 0-to-100 scale, with higher scores indicating a greater negative impact. Change was calculated as the week-8 score minus the baseline score. Negative change values indicate improvement.
Measured: Baseline and week 8
Change From Baseline in Modified Oxford Scale Score
Pelvic floor muscle strength was assessed by digital vaginal palpation using the Modified Oxford Scale, ranging from 0 to 5. Higher scores indicate greater pelvic floor muscle strength. Change was calculated as the week-8 score minus the baseline score. Positive change values indicate improvement.
Measured: Baseline and week 8
Treatment Satisfaction Score
Treatment satisfaction was assessed using a 5-point Likert scale, ranging from 1, very dissatisfied, to 5, very satisfied. Higher scores indicate greater treatment satisfaction.
Measured: Week 8
Number of Participants Who Completed the Treatment Program
Treatment completion was defined as completion of the assigned 8-week intervention program. The number and percentage of participants completing treatment were recorded for each group.
Measured: Week 8
Number of Participants Who Completed the Week-8 Bladder Diary
The number and percentage of participants who provided a complete 3-day bladder diary at the week-8 assessment were recorded for each group.
Measured: Week 8
Number of EMG Biofeedback Sessions Attended
For participants assigned to the combined intervention group, the number of supervised electromyographic biofeedback sessions attended was recorded out of 24 planned sessions.
Measured: Throughout the 8-week intervention period
Number of Participants With Adequate EMG Biofeedback Session Adherence
Adequate adherence was defined as attendance at 75% or more of the 24 planned electromyographic biofeedback sessions, corresponding to at least 18 sessions. The number and percentage of participants meeting this threshold were recorded.
Measured: Throughout the 8-week intervention period
Number of Participants With Adverse Events
Adverse events were monitored throughout the intervention period and recorded by event type and treatment group. Events included electrode-site redness, transient perineal discomfort, post-exercise muscle fatigue, and transient worsening of urinary symptoms.
Measured: From baseline through week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start15 Sep 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
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.
- 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
- Model description
- Two-arm, parallel-group, assessor-blinded randomized controlled trial with 1:1 allocation comparing bladder training alone with bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanko University
- Responsible party
- Principal investigator, Bengisu Tüfekçi, Gaziantep Islam Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728747
- Sponsor's protocol ID
- GIBTU-OAB-EMGBF-01
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request, subject to approval of the proposed research purpose and applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive EMG Biofeedback-Assisted Pelvic Floor Muscle Training in Women With Wet Overactive Bladder and Urodynamically Confirmed Detrusor Overactivity: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07728747
- Acronym / sponsor ID
- GIBTU-OAB-EMGBF-01
- Keywords
- Wet Overactive Bladder, Bladder Training, Pelvic Floor Muscle Training, Electromyographic Biofeedback, Urodynamics, Conservative Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Collaborators
- Sanko University
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 27 Jul 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 causes a sudden and difficult-to-control need to urinate and may be accompanied by urine leakage. Bladder training is commonly used as a first-line treatment. Pelvic floor muscle training supported by electromyographic biofeedback may help women recognize and contract the correct muscles and improve control of urgency and leakage.
The purpose of this randomized controlled trial was to determine whether adding electromyographic biofeedback-assisted pelvic floor muscle training to bladder training provides additional benefit compared with bladder training alone in women with wet overactive bladder and urodynamically confirmed detrusor overactivity.
A total of 64 women were randomly assigned in a 1:1 ratio to receive either bladder training alone or bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training. Both interventions lasted 8 weeks. Participants in the combined intervention group received 24 supervised biofeedback sessions in addition to bladder training.
The primary outcome was the change in daily voiding frequency measured using a 3-day bladder diary. Secondary outcomes included urgency, urgency urinary incontinence, nocturia, incontinence-related quality of life, pelvic floor muscle function, treatment adherence, treatment satisfaction, and adverse events. Outcomes were assessed at baseline and at week 8.
Detailed description
This was an assessor-blinded, two-arm, parallel-group randomized controlled trial conducted in women with wet overactive bladder and urodynamically confirmed detrusor overactivity.
Eligible participants were randomly assigned in a 1:1 ratio to a bladder training group or a bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training group. All participants received an 8-week bladder training program that included education, counseling on fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies.
Participants assigned to the combined intervention additionally received 24 individually supervised electromyographic biofeedback-assisted pelvic floor muscle training sessions over 8 weeks. Surface perineal electrodes were used to provide visual feedback during pelvic floor muscle contractions. Training included slow and fast pelvic floor muscle contractions under the supervision of the same physiotherapist.
Assessments were performed at baseline and at week 8. The primary outcome was the change in mean daily voiding frequency calculated from a 3-day bladder diary. Secondary outcomes included daily urgency episodes, urgency urinary incontinence episodes, nocturia episodes, daily fluid intake, incontinence-related quality of life, the impact of urinary incontinence on daily activities, pelvic floor muscle strength, treatment satisfaction, intervention adherence, and adverse events.
The urologist performing the follow-up outcome assessments was blinded to treatment allocation. Participants and the treating physiotherapist could not be blinded because of the nature of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, assessor-blinded randomized controlled trial with 1:1 allocation comparing bladder training alone with bladder training plus electromyographic biofeedback-assisted pelvic floor muscle training.
| Arm | Type | Receives |
|---|---|---|
| Bladder Training | Active comparator | Behavioral: Bladder TrainingParticipants assigned to this arm received an 8-week bladder training program including education, counseling on fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies. |
| Bladder Training Plus EMG Biofeedback-Assisted Pelvic Floor Muscle Training | Experimental | Behavioral: Bladder Training, Behavioral: EMG Biofeedback-Assisted Pelvic Floor Muscle TrainingParticipants assigned to this arm received the same 8-week bladder training program plus 24 individually supervised electromyographic biofeedback-assisted pelvic floor muscle training sessions delivered three times per week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participants aged 18 years or older
- Presence of wet overactive bladder symptoms
- Detrusor overactivity confirmed by urodynamic testing
- Pelvic floor muscle strength of at least 3/5 according to the Modified Oxford Scale
- Ability to comply with the study procedures and complete the bladder diary
Key exclusion criteria (7 listed)
- Neurogenic bladder
- Active urinary tract infection or vulvovaginitis
- Pregnancy or planning pregnancy
- Urogynecological surgery within the previous 3 months
- Pelvic organ prolapse stage 2 or higher according to the Pelvic Organ Prolapse Quantification system
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 |
|---|---|---|
| Bladder TrainingAn 8-week bladder training program including education on lower urinary tract anatomy and overactive bladder, counseling regarding fluid intake and bladder irritants, timed voiding, progressive extension of voiding intervals, and urgency-suppression strategies. Voiding intervals were individualized according to the baseline bladder diary and gradually increased according to participant tolerance. | Behavioural | Bladder Training, Bladder Training Plus EMG Biofeedback-Assisted Pelvic Floor Muscle Training |
| EMG Biofeedback-Assisted Pelvic Floor Muscle TrainingAn 8-week individually supervised pelvic floor muscle training program using surface electromyographic biofeedback. Participants received three sessions per week for a total of 24 sessions. Surface perineal electrodes provided visual feedback during isolated pelvic floor muscle contractions. Each session included 40 slow contractions consisting of 10 seconds of contraction and 20 seconds of relaxation, followed by five sets of 10 fast contractions consisting of 1 second of contraction and 2 seconds of relaxation, with 2-minute rest periods between sets. | Behavioural | Bladder Training Plus EMG Biofeedback-Assisted Pelvic Floor Muscle Training |
Primary outcome
Change From Baseline in Mean Daily Voiding Frequency
Time frame: Baseline and week 8
Mean daily voiding frequency was calculated as the mean number of voids per day recorded in a 3-day bladder diary. Change was calculated as the week-8 value minus the baseline value. Negative change values indicate a reduction in daily voiding frequency.
13 secondary outcomes
Change From Baseline in Mean Daily Urgency Episodes
Time frame: Baseline and week 8
Change From Baseline in Mean Daily Urgency Urinary Incontinence Episodes
Time frame: Baseline and week 8
Change From Baseline in Mean Nightly Nocturia Episodes
Time frame: Baseline and week 8
Change From Baseline in Mean Daily Fluid Intake
Time frame: Baseline and week 8
Change From Baseline in Incontinence Quality of Life Questionnaire Total Score
Time frame: Baseline and week 8
Change From Baseline in Incontinence Impact Questionnaire-7 Total Score
Time frame: Baseline and week 8
Change From Baseline in Modified Oxford Scale Score
Time frame: Baseline and week 8
Treatment Satisfaction Score
Time frame: Week 8
Number of Participants Who Completed the Treatment Program
Time frame: Week 8
Number of Participants Who Completed the Week-8 Bladder Diary
Time frame: Week 8
Number of EMG Biofeedback Sessions Attended
Time frame: Throughout the 8-week intervention period
Number of Participants With Adequate EMG Biofeedback Session Adherence
Time frame: Throughout the 8-week intervention period
Number of Participants With Adverse Events
Time frame: From baseline through week 8
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 27 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article will be available from the corresponding author upon reasonable request, subject to approval of the proposed research purpose and applicable ethical and institutional requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bladder Training and EMG Biofeedback-Assisted Pelvic Floor Muscle Training in people with Overactive Bladder (OAB) and Detrusor Overactivity, run by Gaziantep Islam Science and Technology 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 5 inclusion and 7 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 27 Jul 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?
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?
Change From Baseline in Mean Daily Voiding Frequency (time frame: Baseline and week 8). 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 27 Jul 2026.