Clinical trial NCT00197314: Effectiveness of Circular Muscle Exercise (Paula Method) Versus Kegel Exercise for Urinary Stress Incontinence
Official title: A Randomized Controlled Trial of Circular Muscle Exercises (Paula Method) vs. Pelvic Floor Training (Kegel Exercises) for Urinary Stress Incontinence in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Stress Incontinence (SI)
Keywords: Urinary stress incontinence
Randomized trial
circular muscle training
pelvic floor training
bioequivalence
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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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Primary outcomes:
measure: Mean change in grams of urinary leakage as measured by Pad test
Secondary outcomes:
measure: Quality of life as measured by IQOL scale, sexuality as measured by questionnaire, subjective assessment of SI and general health
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Dr. Ora Paltiel
Study officials:
affiliation: Hadassah University Hospital
name: Ora B Paltiel, MD
role: PRINCIPAL_INVESTIGATOR
References: