Stress Urinary Incontinence, Sexual Satisfaction, Quality of Life
Conditions
Brief summary
The Investigators decided to examine whether the Paula method is more effective than Pelvic Floor Muscle Training (PFMT) in terms of urinary leakage amount, as it measured by pad test in menopause women without an hormonal therapy. In addition to the pad test and two urinary incontinence questionnaires, we will use other assessment tools such as; quality of life and sexual function which have been found to correlate significantly with pad test results. These results may indicate that menopausal women with Stress Urinary Incontinence may be more successful controlling incontinence if they will practice the Paula method as compared to PFMT.
Interventions
BEHAVIORALPaula Method
All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list.
BEHAVIORALPelvic Floor Muscle Training (PFMT)
All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list .
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* women after menopause (12 months with no period) * aged 40 or more * have a positive pad test leakage of 1-50 grams * no systemic or local hormonal therapy * literate in Hebrew and/or English
Exclusion criteria
* women suffering from illnesses which limit physical activity (cardiac, respiratory, psychiatric or neurological disorders) * pelvic surgery within the last 6 months * post hysterectomy or oophorectomy genital prolapse grade 3 or higher
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the quantity of urinary leakage, measured by the one hour pad test | 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention | To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID | 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention | — |
| improvement of sexual function | 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention | To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI |
| improvement of quality of life | 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention | To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI |
Countries
Israel
Outcome results
None listed