Asess if adding vaginal spheres treatment to the conventional Pelvic Floor Muscle Trainning (PFMT) produces a greater decrease in the severity of the stress urinary incontinence or a greater perceived quality of life related to incontinence.
The intervention group will perform the pelvic floor muscle trainning (PFMT) plus the use of vaginal spheres, while the control group will perform the PFMT treatment only, daily at home. The study will be conducted on women with stress urinary incontinence. The intervention will last four months and will consist of a monthly session with the physiotherapist, doing a total of 4 sessions and the final assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
The home guideline for placement of the vaginal spheres will be as described in next: st-2nd week 15 minutes, 1 time a day nd-4th week 30 minutes, 1 time a day 4th-8th week 1 hour, 1 time a day 8th-12th week 2 hours, 1 time a day 12th-16th week 3 hours, 1 time a day
According to the PERFECT score, a daily home guideline for the performance of PFMT will be requested three times a day, two types of exercises (endurance and strength), and eight repetitions of each.
RAPbarcelona SL
Barcelona, Spain
Severity of urinary incontinence using the ICIQ-SF questionnaire (International Consultation on Incontinence Questionnaire Short form) at Week 16.
The ICIQ-SF is a validated self-reported instrument assessing the urinary incontinence severity and It's quality of life. Possible scores range from 0 (no incontinence) to 21 (severe incontinence). Change=(Week 16 score - baseline score).
Time frame: Time Frame: Baseline and Week 16
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