Urinary Stress Incontinence (SI) Clinical Trial
Official title:
A Randomized Controlled Trial of Circular Muscle Exercises (Paula Method) vs. Pelvic Floor Training (Kegel Exercises) for Urinary Stress Incontinence in Women
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.
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.
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment