Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197314
Status:
COMPLETED
Last Update Posted:
2006-11-07
First Post:
2005-09-12
Brief Title:
Effectiveness of Circular Muscle Exercise Paula Method Versus Kegel Exercise for Urinary Stress Incontinence
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
A Randomized Controlled Trial of Circular Muscle Exercises Paula Method vs Pelvic Floor Training Kegel Exercises for Urinary Stress Incontinence in Women
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 incontinenceSI 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None