Clinical trial NCT02851719: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Keywords: Urinary Incontinence, Stress
Pelvic Floor
Exercise
Patient Compliance
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-08-02
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pad test
timeFrame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Secondary outcomes:
measure: Change in 7-Day Voiding Diary
timeFrame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
measure: Change in pelvic floor muscle function (Oxford Grading Scale)
timeFrame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
measure: Change in pelvic floor muscle function (Peritron manometer)
timeFrame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
measure: Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
timeFrame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
measure: Subjective cure of SUI ("satisfied" or "dissatisfied")
timeFrame: After 3 months of supervised treatment and at 9-month follow-up
measure: Frequency and adhesion to the home exercises
timeFrame: After 3 months of supervised treatment and at 9-month follow-up
measure: Frequency of the outpatient sessions
timeFrame: After 3 months of supervised treatment
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Fatima F Fitz, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: