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

Hadassah Medical Center

Status: Withdrawn

Conditions: Quality of Life; Stress Urinary Incontinence; Sexual Satisfaction

Treatments: Behavioral: Paula Method; Behavioral: Pelvic Floor Muscle Training (PFMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01763957

Paula/PFMT-HMO-CTIL

Details and patient eligibility

About

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.

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Pelvic Floor Muscle Training (PFMT)

Active Comparator group

Treatment:

Behavioral: Pelvic Floor Muscle Training (PFMT)

Paula Method

Active Comparator group

Treatment:

Behavioral: Paula Method