Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Incontinence, Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BF group

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

Group Type EXPERIMENTAL

PFMT with biofeedback + Home PFMT

Intervention Type OTHER

24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).

PFMT group

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

Group Type ACTIVE_COMPARATOR

PFMT without biofeedback + Home PFMT

Intervention Type OTHER

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

Interventions

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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).

Intervention Type 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).

Intervention Type OTHER

Other Intervention Names

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Biofeedback PFMT alone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No