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

NCT07728747 | Completed

• 1 other identifier: GIBTU-OAB-EMGBF-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Overactive Bladder (OAB); Detrusor Overactivity; Urgency Urinary Incontinence

Keywords

Wet Overactive Bladder; Bladder Training; Pelvic Floor Muscle Training; Electromyographic Biofeedback; Urodynamics; Conservative Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change From Baseline in Mean Daily Urgency Episodes

  Baseline and week 8

• Change From Baseline in Mean Daily Urgency Urinary Incontinence Episodes

  Baseline and week 8

• Change From Baseline in Mean Nightly Nocturia Episodes

  Baseline and week 8

• Change From Baseline in Mean Daily Fluid Intake

  Baseline and week 8

• Change From Baseline in Incontinence Quality of Life Questionnaire Total Score

  Baseline and week 8

Study Arms (2)

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.

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.

Behavioral: Bladder Training; Behavioral: EMG Biofeedback-Assisted Pelvic Floor Muscle Training

Interventions

Bladder Training BEHAVIORAL

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.

Bladder Training; Bladder Training Plus EMG Biofeedback-Assisted Pelvic Floor Muscle Training

EMG Biofeedback-Assisted Pelvic Floor Muscle Training BEHAVIORAL

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.

Bladder Training Plus EMG Biofeedback-Assisted Pelvic Floor Muscle Training

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziantep Islam Science and Technology University: lead
• Sanko University: collaborator

Study Sites (1)

SANKO University Sani Konukoglu Application and Research Hospital

Gaziantep, Şahinbey, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The urologist who performed the week-8 follow-up outcome assessments was blinded to group allocation. Participants and the treating physiotherapist could not be blinded because of the nature of the interventions. Participants were instructed not to disclose their assigned group during outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: September 15, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning after publication of the main study results and available for 5 years.
• 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.

Locations

TU (1)