CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 445 enrolled
Drug / intervention
Behavioral Therapy +2 morebehavioral
Likely dose
Not stated in record
Key inclusion· 4
  • Stress urinary incontinence or stress-predominant mixed urinary incontinence with ≥2 stress incontinence episodes on 7-day bladder diary, where stress episodes exceed urge episodes
  • Urinary incontinence present for ≥3 months
  • Ambulatory adult women
  • Stage 0-I-II pelvic organ prolapse
Key exclusion· 7
  • Continual/continuous urine leakage
  • Pregnant or planning pregnancy within 1 year
  • Active urinary tract infection
  • Urinary retention

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00270998
NCT00270998Phase 3Completed

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

NICHD Pelvic Floor Disorders Network·interventional·Posted Dec 29, 2005·Updated May 30, 2018

In Brief

A Phase 3 clinical trial evaluating Behavioral Therapy, Intravaginal Pessary, and 1 other intervention for Stress Urinary Incontinence and Urinary Incontinence. Completed, enrolled 445 participants across 8 sites.

Detailed 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 study's primary hypothesis is that pessary use is more effective than pelvic muscle exercises after 3 months of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 29, 2005
Enrollment StartJun 1, 2005
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.5 years ago

Interventions

Behavioral Therapybehavioral

Pelvic muscle training and exercises

Intravaginal Pessarydevice

Intravaginal pessary

Pessary combined with behavioral therapydevice

Intravaginal pessary and behavioral therapy