Bladder Training With or Without Biofeedback-Assisted Pelvic Floor Muscle Training for Women With Wet Overactive Bladder

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.

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.

Study Overview

• Status: Completed
• Conditions: Urgency Urinary Incontinence; Overactive Bladder (OAB); Detrusor Overactivity
• Intervention / Treatment: Behavioral: Bladder Training; Behavioral: EMG Biofeedback-Assisted Pelvic Floor Muscle Training

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Şahinbey
    • Gaziantep, Şahinbey, Turkey (Türkiye), 27010
      • SANKO University Sani Konukoglu Application and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bladder Training; 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.	Behavioral: Bladder Training; 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.
Experimental: Bladder Training Plus EMG Biofeedback-Assisted Pelvic Floor Muscle Training; 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.	Behavioral: Bladder Training; 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.; Behavioral: EMG Biofeedback-Assisted Pelvic Floor Muscle Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From baseline through week 8

Collaborators and Investigators

• Sponsor: Gaziantep Islam Science and Technology University
• Collaborators: Sanko University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Urodynamics; Conservative Treatment; Pelvic Floor Muscle Training; Electromyographic Biofeedback; Bladder Training; Wet Overactive Bladder
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive
• Other Study ID Numbers: GIBTU-OAB-EMGBF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning after publication of the main study results and available for 5 years.
• IPD Sharing Access Criteria: De-identified individual participant data underlying the results reported in the published article will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the corresponding author. Access will be subject to approval of the proposed purpose, applicable ethical and institutional requirements, and completion of a data use agreement. The data may be used only for the approved research purpose.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No