The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. The hypothesis of this study is that home pelvic floor muscle training is as effective as outpatient pelvic floor muscle training for the treatment of stress urinary incontinence.
Success with the pelvic floor muscle training (PFMT) is hampered by non-adherence, which is related to factors such as inability to contract the pelvic floor muscles and lack of motivation. Thus under supervision by a physiotherapist (outpatient training), PFMT has the potential of improving adherence to training and has been demonstrated to be more effective when compared to unsupervised PFMT (home training). The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. This is a randomized controlled trial and which will be conducted at the Division of Urogynecology and Reconstructive Pelvic Surgery at the Federal University of Sao Paulo, Brazil. As a primary endpoint, the standardized volume test pad (250 mL) will be used. To assert that one of the groups (home PFMT or outpatient PFMT) is superior to the other, it will be necessary to find 38.5% more patients cured when the groups are compared. Secondary outcome measures will be used, assessment of the pelvic floor muscles function, urinary symptoms, quality of life and subjective cure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Patients will perform pelvic floor exercises at home.
Patients will perform pelvic floor exercises in the outpatient.
Fátima Faní Fitz
São Paulo, Brazil
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 treatment
Change in 7-Day Voiding Diary
To assess the loss efforts
Time frame: Baseline and after 3 months of treatment
Change in pelvic floor muscle function (Oxford Grading Scale)
To assess the function of the pelvic floor muscle
Time frame: Baseline and after 3 months of treatment
Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
To quantify the impact of SUI on quality of life
Time frame: Baseline and after 3 months of treatment
Subjective cure of SUI ("satisfied" or "dissatisfied")
To evaluate the patient satisfaction with treatment
Time frame: Baseline and after 3 months of treatment
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