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Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

Primary Purpose

Urinary Incontinence, Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PFMT with biofeedback + Home PFMT
PFMT without biofeedback + Home PFMT
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring Urinary Incontinence, Stress, Pelvic Floor, Exercise, Patient Compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    BF group

    PFMT group

    Arm Description

    24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises.

    24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises.

    Outcomes

    Primary Outcome Measures

    Change in pad test
    To quantify the severity of SUI and as the tool to estimate objective cure rate

    Secondary Outcome Measures

    Change in 7-Day Voiding Diary
    To assess the loss efforts
    Change in pelvic floor muscle function (Oxford Grading Scale)
    To assess the function of the pelvic floor muscle
    Change in pelvic floor muscle function (Peritron manometer)
    To assess the function of the pelvic floor muscle
    Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
    To quantify the impact of SUI on quality of life
    Subjective cure of SUI ("satisfied" or "dissatisfied")
    To evaluate the patient satisfaction with treatment
    Frequency and adhesion to the home exercises
    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
    The frequency of the outpatient sessions was monitored

    Full Information

    First Posted
    July 28, 2016
    Last Updated
    August 1, 2016
    Sponsor
    Federal University of São Paulo
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02851719
    Brief Title
    Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises
    Official Title
    Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence, Stress
    Keywords
    Urinary Incontinence, Stress, Pelvic Floor, Exercise, Patient Compliance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BF group
    Arm Type
    Experimental
    Arm Description
    24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises.
    Arm Title
    PFMT group
    Arm Type
    Active Comparator
    Arm Description
    24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises.
    Intervention Type
    Other
    Intervention Name(s)
    PFMT with biofeedback + Home PFMT
    Other Intervention Name(s)
    Biofeedback
    Intervention Description
    24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
    Intervention Type
    Other
    Intervention Name(s)
    PFMT without biofeedback + Home PFMT
    Other Intervention Name(s)
    PFMT alone
    Intervention Description
    24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
    Primary Outcome Measure Information:
    Title
    Change in pad test
    Description
    To quantify the severity of SUI and as the tool to estimate objective cure rate
    Time Frame
    Baseline, after 3 months of supervised treatment and at 9-month follow-up
    Secondary Outcome Measure Information:
    Title
    Change in 7-Day Voiding Diary
    Description
    To assess the loss efforts
    Time Frame
    Baseline, after 3 months of supervised treatment and at 9-month follow-up
    Title
    Change in pelvic floor muscle function (Oxford Grading Scale)
    Description
    To assess the function of the pelvic floor muscle
    Time Frame
    Baseline, after 3 months of supervised treatment and at 9-month follow-up
    Title
    Change in pelvic floor muscle function (Peritron manometer)
    Description
    To assess the function of the pelvic floor muscle
    Time Frame
    Baseline, after 3 months of supervised treatment and at 9-month follow-up
    Title
    Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
    Description
    To quantify the impact of SUI on quality of life
    Time Frame
    Baseline, after 3 months of supervised treatment and at 9-month follow-up
    Title
    Subjective cure of SUI ("satisfied" or "dissatisfied")
    Description
    To evaluate the patient satisfaction with treatment
    Time Frame
    After 3 months of supervised treatment and at 9-month follow-up
    Title
    Frequency and adhesion to the home exercises
    Description
    The weekly frequency (days/week that patients performed at least 1 set of exercises) and the number of sets per day
    Time Frame
    After 3 months of supervised treatment and at 9-month follow-up
    Title
    Frequency of the outpatient sessions
    Description
    The frequency of the outpatient sessions was monitored
    Time Frame
    After 3 months of supervised treatment

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatima F Fitz, M.Sc
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The individual participant data (IPD) collected in this study are being analyzed by the researchers to be available.

    Learn more about this trial

    Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

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