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ATLAS: Ambulatory Treatments for Leakage Associated With Stress

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
dwallace, NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier:
NCT00270998
First received: December 27, 2005
Last updated: August 22, 2017
Last verified: August 2017
December 27, 2005
August 22, 2017
June 2005
December 2008   (Final data collection date for primary outcome measure)
  • "Much Better" or "Very Much Better" on PGI-I at 3 Months [ Time Frame: Outcome was measured at three months following randomization. ]
    PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better." Participants were considered a success if they responded "much better" or "very much better," or a failure if they responded otherwise.
  • No Bothersome Stress Incontinence Symptoms at 3 Months [ Time Frame: Outcome was measured at three months following randomization. ]
    Success if participants answer either "no" or "yes" with a bother component of "not at all" or "somewhat" to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.
Questionnaire: Patient Global Impression of Improvement
Complete list of historical versions of study NCT00270998 on ClinicalTrials.gov Archive Site
  • "Much Better" or "Very Much Better" on PGI-I at 12 Months [ Time Frame: Outcome was measured at 12 months following randomization. ]
    PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better." Participants were considered a success if they responded "much better" or "very much better," or a failure if they responded otherwise.
  • No Bothersome Stress Incontinence Symptoms at 12 Months. [ Time Frame: Outcome was measured at 12 months following randomization. ]
    Success if participants answer either "no" or "yes" with a bother component of "not at all" or "somewhat" to all seven Urogenital Distress Inventory-Stress Incontinence Subscale items of the Pelvic Floor Distress Inventory, or a failure if they responded otherwise.
  • 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months [ Time Frame: Outcome was measured at three months following randomization. ]
    Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.
  • 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months [ Time Frame: Outcome was measured at 12 months following randomization. ]
    Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.
  • Satisfaction With Treatment at 3 Months [ Time Frame: Outcome was measured at three months following randomization. ]
    Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.
  • Satisfaction With Treatment at 12 Months [ Time Frame: Outcome was measured at 12 months following randomization. ]
    Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.
  • Incontinent episodes by bladder diary
  • Incontinence-related quality of life
  • Health-related quality of life
  • Patient satisfaction
  • Change in pelvic muscle strength
  • Expectation of treatment benefit
Not Provided
Not Provided
 
ATLAS: Ambulatory Treatments for Leakage Associated With Stress
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Urinary Incontinence
  • Urinary Incontinence
  • Behavioral: Behavioral Therapy
    Pelvic muscle training and exercises
  • Device: Intravaginal Pessary
    Intravaginal pessary
  • Device: Pessary combined with behavioral therapy
    Intravaginal pessary and behavioral therapy
  • Experimental: Intravaginal Pessary
    Pessary restores continence by stabilization of the proximal urethra and urethrovesical junction, facilitating pressure transmission to the proximal urethra.
    Intervention: Device: Intravaginal Pessary
  • Experimental: Behavioral Therapy
    Pelvic floor muscle training and exercise which includes strong contraction of the pelvic floor muscles to prevent incontinence by occluding the urethra and regular practice can improve pelvic muscle support.
    Intervention: Behavioral: Behavioral Therapy
  • Experimental: Pessary combined with behavioral therapy
    Combination of the explanations above.
    Intervention: Device: Pessary combined with behavioral therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
445
December 2008
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00270998
PFDN 13
Yes
Not Provided
Plan to Share IPD: Yes
dwallace, NICHD Pelvic Floor Disorders Network
NICHD Pelvic Floor Disorders Network
Not Provided
Study Chair: Holly E Richter, PhD, MD University of Alabama at Birmingham
NICHD Pelvic Floor Disorders Network
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP