Outpatient Biofeedback in Addition to Home Pelvic Floor Muscle Exercises
- Conditions
- Urinary Incontinence, Stress
- Interventions
- Other: PFMT with biofeedback + Home PFMTOther: PFMT without biofeedback + Home PFMT
- Registration Number
- NCT02851719
- Lead Sponsor
- Federal University of São Paulo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 72
- SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BF group PFMT with biofeedback + Home PFMT 24 outpatient sessions of the PFMT (twice a week) using manometric-based BF equipment and daily home PFMT exercises. PFMT group PFMT without biofeedback + Home PFMT 24 outpatient sessions (twice a week) of PFMT without BF and daily home PFMT exercises.
- Primary Outcome Measures
Name Time Method Change in pad test 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 Outcome Measures
Name Time Method Change in pelvic floor muscle function (Peritron manometer) Baseline, after 3 months of supervised treatment and at 9-month follow-up To assess the function of the pelvic floor muscle
Frequency of the outpatient sessions After 3 months of supervised treatment The frequency of the outpatient sessions was monitored
Change in 7-Day Voiding Diary 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) 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) 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") 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 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