Fátima Faní Fitz
São Paulo, 05311030, Brazil
NCT Number: NCT03058042
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.
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Notify Me18 year–65 year
Female
Interventional
Not applicable
São Paulo, 05311030, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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 inability to contract PFMs previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries
Patients will perform pelvic floor exercises at home.
Patients will perform pelvic floor exercises in the outpatient.
Time frame: Baseline, after 3 months of treatment
To quantify the severity of SUI and as the tool to estimate objective cure rate
Time frame: Baseline and after 3 months of treatment
To assess the loss efforts
Time frame: Baseline and after 3 months of treatment
To assess the function of the pelvic floor muscle
Time frame: Baseline and after 3 months of treatment
To quantify the impact of SUI on quality of life
Time frame: Baseline and after 3 months of treatment
To evaluate the patient satisfaction with treatment
Federal University of São Paulo
Other
Outpatient Pelvic Floor Muscle Training Versus Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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