Urinary Incontinence, Stress
Conditions
Keywords
Urinary Incontinence, Stress, Pelvic Floor; Exercise, Physical Therapy Modalities
Brief summary
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.
Detailed description
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.
Interventions
OTHERExercises of the pelvic floor muscle at home
Patients will perform pelvic floor exercises at home.
OTHERExercises of the pelvic floor muscle in the outpatient
Patients will perform pelvic floor exercises in the outpatient.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Protocol of group I (Outpatient training): Patients will perform 24 outpatient sessions of pelvic floor muscle (PFM) strength training and home training. At the end of one month, the patients will perform PFM evaluation and training progression Group II protocol (home training): Patients will perform strength training of the pelvic floor muscles daily at home. At the end of one month, the patients will return for consultation, in which the PFM evaluation and training progression will be performed.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pad test | Baseline, after 3 months of treatment | To quantify the severity of SUI and as the tool to estimate objective cure rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 7-Day Voiding Diary | Baseline and after 3 months of treatment | To assess the loss efforts |
| Change in pelvic floor muscle function (Oxford Grading Scale) | Baseline and after 3 months of treatment | To assess the function of the pelvic floor muscle |
| Change in Incontinence Quality-of-Life Questionnaire (I-QoL) | Baseline and after 3 months of treatment | To quantify the impact of SUI on quality of life |
| Subjective cure of SUI (satisfied or dissatisfied) | Baseline and after 3 months of treatment | To evaluate the patient satisfaction with treatment |
Countries
Brazil
Outcome results
None listed