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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
Change in pad test
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
Change in 7-Day Voiding Diary
To assess the loss efforts
Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Oxford Grading Scale)
To assess the function of the pelvic floor muscle
Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in pelvic floor muscle function (Peritron manometer)
To assess the function of the pelvic floor muscle
Time frame: Baseline, after 3 months of supervised treatment and at 9-month follow-up
Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
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
Subjective cure of SUI ("satisfied" or "dissatisfied")
To evaluate the patient satisfaction with treatment
Time frame: After 3 months of supervised treatment and at 9-month follow-up
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
Time frame: After 3 months of supervised treatment and at 9-month follow-up
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Frequency of the outpatient sessions
The frequency of the outpatient sessions was monitored
Time frame: After 3 months of supervised treatment