Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270998
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2005-12-27
Brief Title:
ATLAS Ambulatory Treatments for Leakage Associated With Stress
Sponsor:
NICHD Pelvic Floor Disorders Network
Organization:
NICHD Pelvic Floor Disorders Network
Study Overview
Official Title:
ATLAS Ambulatory Treatments for Leakage Associated With Stress A Randomized Trial of Pelvic Muscle Exercise Versus Incontinence Pessary Versus Both for Women With Stress or Mixed Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2018-04
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:
Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or stress such as coughing sneezing or exercise Treatment for stress incontinence can be surgical or non-surgical Different non-surgical treatments include pelvic muscle exercises and pessary use Pelvic muscle exercises often known as Kegel exercises train and strengthen the pelvic muscles and improve incontinence A pessary is a medical device that fits inside the vagina to give the urethra and bladder extra support and prevent or reduce urinary incontinence Exercises and pessary use can help women with stress incontinence but it is not known which treatment is better or if a combination of the two treatments at the same time is best This study will determine whether pelvic muscle training and exercises pessary use or a combination of both exercises and pessary is most effective at improving incontinence in women The studys primary hypothesis is that pessary use is more effective than pelvic muscle exercises after 3 months of treatment
Detailed Description:
Women commonly have symptoms of stress urinary incontinence leakage with physical stress such as coughing or sneezing and urinary urgency or urge incontinence leakage associated with the overwhelming urge to urinate Non-surgical treatment is usually offered as first-line therapy such as pelvic muscle exercises Kegel exercises or pessary use A pessary is a small ring that fits inside the vagina Pelvic muscle training and exercises may help incontinence by increased awareness and strength of the muscles that are used in holding the urethra closed Pessary use may help incontinence by providing more support to the bladder and urethra Both treatments can be helpful in reducing or eliminating incontinence but it is not known which treatment is better The study will compare the level of improvement with pelvic muscle exercises pessary use and a combination of both exercises and pessary
Women with stress or mixed urinary incontinence will be randomly assigned to 1 of 3 groups 1 pelvic muscle training and exercises 2 pessary use and 3 both exercises and pessary Women in the exercises groups will have 4 visits over 8 weeks with a specially trained therapist for pelvic muscle training and exercises Women in the pessary group will be fitted with a pessary to be worn continuously Assessments will include questionnaires bladder diary and physical examination Follow-up evaluations occur at 3 months 6 months by telephone only and 1 year after initial treatment
Comparisons The level of improvement after treatment will be compared in the 3 groups In addition women in the 3 groups will record the number of accidental leakage episodes by bladder diary and the frequency of those episodes will be compared in the 3 groups Other aspects of health including health-related quality of life will be compared in the 3 groups
Women with stress or mixed urinary incontinence will be randomly assigned to 1 of 3 groups 1 pelvic muscle training and exercises 2 pessary use and 3 both exercises and pessary Women in the exercises groups will have 4 visits over 8 weeks with a specially trained therapist for pelvic muscle training and exercises Women in the pessary group will be fitted with a pessary to be worn continuously Assessments will include questionnaires bladder diary and physical examination Follow-up evaluations occur at 3 months 6 months by telephone only and 1 year after initial treatment
Comparisons The level of improvement after treatment will be compared in the 3 groups In addition women in the 3 groups will record the number of accidental leakage episodes by bladder diary and the frequency of those episodes will be compared in the 3 groups Other aspects of health including health-related quality of life will be compared in the 3 groups
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