ATLAS: Ambulatory Treatments for Leakage Associated With Stress

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270998
• Other study ID #: PFDN 13
• Status: Completed
• Phase: Phase 3
• Start date: June 2005
• Est. completion date: December 2008

Study information

• Verified date: April 2018
• Source: NICHD Pelvic Floor Disorders Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• Behavioral Therapy
Pelvic muscle training and exercises

Device:
• Intravaginal Pessary
Intravaginal pessary
• Pessary combined with behavioral therapy
Intravaginal pessary and behavioral therapy

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of California, San Diego Medical Center	La Jolla	California
United States	Loyola University	Maywood	Illinois
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
NICHD Pelvic Floor Disorders Network

Country where clinical trial is conducted

United States, 

References & Publications (2)

Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, Bradley CS, Handa VL, Borello-France D, Goode PS, Zyczynski H, Lukacz ES, Schaffer J, Barber M, Meikle S, Spino C; Pelvic Floor Disorders Network. Continence pessary compared with behavioral — View Citation

Richter HE, Burgio KL, Goode PS, Borello-France D, Bradley CS, Brubaker L, Handa VL, Fine PM, Visco AG, Zyczynski HM, Wei JT, Weber AM; Pelvic Foor Desorders Network. Non-surgical management of stress urinary incontinence: ambulatory treatments for leakage associated with stress (ATLAS) trial. Clin Trials. 2007;4(1):92-101. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Much Better" or "Very Much Better" on PGI-I at 3 Months	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.	Outcome was measured at three months following randomization.
Primary	No Bothersome Stress Incontinence Symptoms at 3 Months	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.	Outcome was measured at three months following randomization.
Secondary	"Much Better" or "Very Much Better" on PGI-I at 12 Months	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.	Outcome was measured at 12 months following randomization.
Secondary	No Bothersome Stress Incontinence Symptoms at 12 Months.	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.	Outcome was measured at 12 months following randomization.
Secondary	75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months	Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.	Outcome was measured at three months following randomization.
Secondary	75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months	Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise.	Outcome was measured at 12 months following randomization.
Secondary	Satisfaction With Treatment at 3 Months	Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.	Outcome was measured at three months following randomization.
Secondary	Satisfaction With Treatment at 12 Months	Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.	Outcome was measured at 12 months following randomization.

External Links

•   Public website for the Pelvic Floor Disorders Network
•   Website of the National Institute of Child Health and Human Development, which funds the Pelvic Floor Disorders Network