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

22 juli 2026 bijgewerkt door: Bengisu Tüfekçi, Gaziantep Islam Science and Technology University

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

64

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: 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.
Experimenteel: 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.
Gedragsmatig: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Mean Daily Voiding Frequency
Tijdsspanne: 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.
Baseline and week 8

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Mean Daily Urgency Episodes
Tijdsspanne: Baseline and week 8
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
Tijdsspanne: Baseline and week 8
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
Tijdsspanne: Baseline and week 8
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
Tijdsspanne: Baseline and week 8
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
Tijdsspanne: Baseline and week 8
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
Tijdsspanne: Baseline and week 8
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
Tijdsspanne: Baseline and week 8
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
Tijdsspanne: Week 8
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
Tijdsspanne: Week 8
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
Tijdsspanne: Week 8
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
Tijdsspanne: Throughout the 8-week intervention period
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
Tijdsspanne: Throughout the 8-week intervention period
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
Tijdsspanne: From baseline through week 8
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gaziantep Islam Science and Technology University

Medewerkers

Sanko University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 september 2025

Primaire voltooiing (Werkelijk)

1 april 2026

Studie voltooiing (Werkelijk)

1 april 2026

Studieregistratiedata

Eerst ingediend

22 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juli 2026

Eerst geplaatst (Werkelijk)

27 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GIBTU-OAB-EMGBF-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

Beginning after publication of the main study results and available for 5 years.

IPD-toegangscriteria voor delen

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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