Paula Method Compared to Pelvic Floor Muscle Training (PFMT), for Urinary Stress Incontinence

Hadassah Medical Organization

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Stress Urinary Incontinence Sexual Satisfaction Quality of Life

Interventions

Paula MethodBEHAVIORAL

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.

Pelvic Floor Muscle Training (PFMT)BEHAVIORAL

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

Outcomes

Primary Outcomes

change in the quantity of urinary leakage, measured by the one hour pad test

To examine whether the Paula method intervention is more effective than PFMT in reducing urinary leakage in menopausal women with SUI

Time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention

Secondary Outcomes

change in the urinary leakage questionnaires, measured by ICIQ-UI and QUID

Time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention

improvement of sexual function

To evaluate the effectiveness of both methods to improve sexual function in women diagnosed with SUI

Time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention

improvement of quality of life

To evaluate the effectiveness of both methods to improve quality of life in women diagnosed with SUI

Time frame: 1) Baseline 2) After 12 weeks of exercise intervention 3) 12 months after completion of the intervention

Data from ClinicalTrials.gov

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