ATLAS: Ambulatory Treatments for Leakage Associated With Stress

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
dwallace, RTI International
ClinicalTrials.gov Identifier:
NCT00270998
First received: December 27, 2005
Last updated: September 27, 2013
Last verified: September 2013

December 27, 2005
September 27, 2013
June 2005
December 2008   (final data collection date for primary outcome measure)
Questionnaire: Patient Global Impression of Improvement [ Time Frame: 3 and 12 month ] [ Designated as safety issue: No ]
Questionnaire: Patient Global Impression of Improvement
Complete list of historical versions of study NCT00270998 on ClinicalTrials.gov Archive Site
  • Incontinent episodes by bladder diary [ Time Frame: 3 and 12 month ] [ Designated as safety issue: No ]
  • Incontinence-related quality of life [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Change in pelvic muscle strength [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Expectation of treatment benefit [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Urinary Incontinence
  • Mixed Stress and Urge Urinary Incontinence
  • Behavioral: Pelvic muscle training and exercises
    Pelvic muscle training and exercises
  • Device: Intravaginal incontinence pessary
    Intravaginal incontinence pessary
  • Device: Both pessary and pelvic muscle exercises
    Intravaginal incontinence pessary and pelvic muscle training and exercises
  • Experimental: 1
    Pessary
    Intervention: Device: Intravaginal incontinence pessary
  • Experimental: 2
    Behavioral therapy
    Intervention: Behavioral: Pelvic muscle training and exercises
  • Experimental: 3
    Combination of pessary and behavioral therapy
    Intervention: Device: Both pessary and pelvic muscle exercises

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
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.
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00270998
PFDN 13
Yes
dwallace, RTI International
NICHD Pelvic Floor Disorders Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Holly E Richter, PhD, MD University of Alabama at Birmingham
NICHD Pelvic Floor Disorders Network
September 2013

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