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NCT00270998 · ClinicalTrials.gov registry record · Phase 3

ATLAS: Ambulatory Treatments for Leakage Associated With Stress

A Phase 3 study, sponsored by NICHD Pelvic Floor Disorders Network.

Completed
Registry status
Phase 3
Development phase
445
Enrollment target

NCT00270998 is a Phase 3 study that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 445 participants.

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The verdict

NCT00270998, a Phase 3 study, has completed, sponsored by NICHD Pelvic Floor Disorders Network.

COMPLETED
Registry status
Phase 3
Development phase
445 participants
Enrollment target

Study 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.

Interventions

  • BEHAVIORAL Behavioral Therapy
  • DEVICE Intravaginal Pessary
  • DEVICE Pessary combined with behavioral therapy

Trial Details

FieldValue
Enrollment Target 445 participants
Start Date 2005-06
Est. Completion 2008-12
Phase Phase 3

What the Registry Record Tells You About NCT00270998

The ClinicalTrials.gov registry entry for NCT00270998 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 445 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Behavioral Therapy is the first listed.

NCT00270998 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00270998 about?

NCT00270998 is a clinical study titled "ATLAS: Ambulatory Treatments for Leakage Associated With Stress". 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 mus...

What is the current status of trial NCT00270998?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 445 participants. The study started on 2005-06. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00270998?

The interventions under investigation include: Behavioral Therapy (BEHAVIORAL), Intravaginal Pessary (DEVICE), Pessary combined with behavioral therapy (DEVICE).

Who is sponsoring clinical trial NCT00270998?

This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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