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

NCT ID: NCT01763957

Last Updated: 2013-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stress Urinary Incontinence Sexual Satisfaction Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pelvic Floor Muscle Training (PFMT)

Group Type ACTIVE_COMPARATOR

Pelvic Floor Muscle Training (PFMT)

Intervention Type BEHAVIORAL

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 .

Paula Method

Group Type ACTIVE_COMPARATOR

Paula Method

Intervention Type BEHAVIORAL

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.

Interventions

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Paula 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.

Intervention Type BEHAVIORAL

Pelvic 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 .

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Drorith Hochner-Celnikier, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Paula/PFMT-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id