Clinical trial NCT03058042: Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence
Official title: Outpatient Pelvic Floor Muscle Training Versus Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Keywords: Urinary Incontinence, Stress
Pelvic Floor; Exercise
Physical Therapy Modalities
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pad test
timeFrame: Baseline, after 3 months of treatment
Secondary outcomes:
measure: Change in 7-Day Voiding Diary
timeFrame: Baseline and after 3 months of treatment
measure: Change in pelvic floor muscle function (Oxford Grading Scale)
timeFrame: Baseline and after 3 months of treatment
measure: Change in Incontinence Quality-of-Life Questionnaire (I-QoL)
timeFrame: Baseline and after 3 months of treatment
measure: Subjective cure of SUI ("satisfied" or "dissatisfied")
timeFrame: Baseline and after 3 months of treatment
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Fátima Faní Fitz
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rodrigo A Castro
role: STUDY_DIRECTOR
References: