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

22 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

64

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Mean Daily Voiding Frequency
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Mean Daily Urgency Episodes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gaziantep Islam Science and Technology University

Collaboratori

Sanko University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 settembre 2025

Completamento primario (Effettivo)

1 aprile 2026

Completamento dello studio (Effettivo)

1 aprile 2026

Date di iscrizione allo studio

Primo inviato

22 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 luglio 2026

Primo Inserito (Effettivo)

27 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GIBTU-OAB-EMGBF-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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