Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

Overview

To test whether biofeedback (BF) added to pelvic floor muscle training (PFMT) promotes additional benefits over PFMT alone in the stress urinary incontinence (SUI) treatment.

Full Title of Study: “Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2011

Detailed Description

Introduction: The aim of this study was to test the hypothesis that outpatient BF added to home PFMT results in increased frequency of home exercises sets per month performed by the patients and objective cure rate after 3 months of supervised training. Secondarily, to investigate other subjective and objective clinical parameters in the groups that received or not BF together with PFMT after 3 months of supervised training, and in a longer term of 9-month follow-up. Method: 72 incontinent women were randomized to the: BF Group (outpatient BF + home PFMT) or PFMT Group (outpatient PFMT + home PFMT). Assessments: baseline after 3 months of supervised treatment and at 9-month follow-up (after 6 additional months of home PFMT without supervision). Primary outcomes: adherence – monthly exercises sets performed (exercise diary) and objective cure of SUI (pad test) after 3 months. Secondary outcomes: urinary symptoms, muscle function, quality of life, adhesion and subject cure at the two time-points.

Interventions

  • Other: PFMT with biofeedback + Home PFMT
    • 24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
  • Other: PFMT without biofeedback + Home PFMT
    • 24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).

Arms, Groups and Cohorts

  • Experimental: BF group
    • 24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises.
  • Active Comparator: PFMT group
    • 24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises.

Clinical Trial Outcome Measures

Primary Measures

  • Change in pad test
    • Time Frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
    • To quantify the severity of SUI and as the tool to estimate objective cure rate

Secondary Measures

  • Change in 7-Day Voiding Diary
    • Time Frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
    • To assess the loss efforts
  • Change in pelvic floor muscle function (Oxford Grading Scale)
    • Time Frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
    • To assess the function of the pelvic floor muscle
  • Change in pelvic floor muscle function (Peritron manometer)
    • Time Frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
    • To assess the function of the pelvic floor muscle
  • Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
    • Time Frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
    • To quantify the impact of SUI on quality of life
  • Subjective cure of SUI (“satisfied” or “dissatisfied”)
    • Time Frame: After 3 months of supervised treatment and at 9-month follow-up
    • To evaluate the patient satisfaction with treatment
  • Frequency and adhesion to the home exercises
    • Time Frame: After 3 months of supervised treatment and at 9-month follow-up
    • The weekly frequency (days/week that patients performed at least 1 set of exercises) and the number of sets per day
  • Frequency of the outpatient sessions
    • Time Frame: After 3 months of supervised treatment
    • The frequency of the outpatient sessions was monitored

Participating in This Clinical Trial

Inclusion Criteria

  • SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test Exclusion Criteria:

  • younger than 18 years old – chronic degenerative diseases – pelvic organ prolapse greater than stage I by POP-Q – neurologic or psychiatric diseases – previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Collaborator
    • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fatima Fitz, Physical Therapist – Federal University of São Paulo
  • Overall Official(s)
    • Fatima F Fitz, M.Sc, Principal Investigator, Federal University of São Paulo

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