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NCT Number: NCT00197314

Effectiveness of Circular Muscle Exercise (Paula Method) Versus Kegel Exercise for Urinary Stress Incontinence

This is a randomized controlled trial comparing two methods of exercise for the treatment of stress incontinence ( loss of urine after physical exertion) in women. We are comparing the Paula method of circular muscle exercise, in which circular muscles controlling sphincters of the body (such as the eyes, mouth and rectum) are exercised, with pelvic floor training (Kegel exercises) in women in the community. The study hypothesis is that the effectiveness of circular muscle exercises is equivalent to pelvic floor training among women with this disorder.

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Key information

Conditions

Urinary Stress Incontinence (SI) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Ora Paltiel

Jerusalem, 91120, Israel

About this study

Background: Urinary stress incontinence(SI) is defined as involuntary urinary loss which appears during increased intra-abdominal pressure which can be measured objectively. It is an important social and hygienic problem. Its prevalence varies fron 12-55% depending on age, and geography. The economic costs of this condition were estimated to reach 24 billion dollars in the US in 1995. The objectives of this study are to evaluate two non-invasive methods of treatment of stress incontinence.

Methods: 200 women who chosen from the community and suffering from SI will enter the study and will be randomized to one of two arms. The first arm is the Paula method of circular muscle exercises: these women will receive private lessons from a registered Paula instructor. The system is based on activating circular muscles in the body. The second arm will receive instruction in pelvic floor muscle training by a physiotherapist.

The clinical trial will compare the efficacy of the methods for the treatment of SI. The candidates for inclusion in the trial will undergo a gynecological exam and a "Pad Test". The efficacy will be measured in terms of changes in the Pad test (quantity of urinary leakage) and subjective reports of the participants on leakage, quality of life and sexual function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

ambulatory women, aged 20-65, living in Jerusalem area, able to understand instruction in Hebrew or English, suffering from urinary stress incontinence with a positive Pad test of at least 1 gm -

Exclusion criteria

pregnant,within 12 weeks of delivery,6 weeks since abortion,breastfeeding, illnesses which limit physical activity (cardiac, respiratory, psychiatric and neurological), Pad test < 1gm,pelvic surgery within last 6 months, genital prolapse Grade 3 or higher, previous surgery for urinary incontinence, previous pelvic radiation therapy

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Treatment and study plan

circular muscle exercises versus pelvic floor exercises

Behavioral

Primary outcomes

  1. Mean change in grams of urinary leakage as measured by Pad test

Secondary outcomes

  1. Quality of life as measured by IQOL scale, sexuality as measured by questionnaire, subjective assessment of SI and general health

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

A Randomized Controlled Trial of Circular Muscle Exercises (Paula Method) vs. Pelvic Floor Training (Kegel Exercises) for Urinary Stress Incontinence in Women

Important dates

Study start
2004
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Nov 7, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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