ATLAS: Ambulatory Treatments for Leakage Associated With Stress
| Status: | Completed |
|---|---|
| Conditions: | Overactive Bladder, Urology, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 6/1/2018 |
| Start Date: | June 2005 |
| End Date: | December 2008 |
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
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 study's primary hypothesis is that pessary use is more effective
than pelvic muscle exercises after 3 months of treatment.
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 study's primary hypothesis is that pessary use is more effective
than pelvic muscle exercises after 3 months of treatment.
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.
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.
Inclusion Criteria:
- Stress urinary incontinence or stress-predominant mixed urinary incontinence, with at
least 2 episodes of stress incontinence on 7-day bladder diary and the number of
stress incontinence episodes exceeding the number of urge incontinence episodes.
- Urinary incontinence for at least three months.
- Ambulatory adult women.
- Stage 0-I-II pelvic organ prolapse.
Exclusion Criteria:
- Continual urine leakage.
- Pregnancy or planning pregnancy within 1 year.
- Active urinary tract infection.
- Urinary retention.
- Currently on medication for incontinence.
- Currently using a pessary.
- Neurologic condition that affects bladder function.
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