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Phase 3 N=445 Randomized Single-blind Treatment

ATLAS: Ambulatory Treatments for Leakage Associated With Stress

Stress Urinary Incontinence · Urinary Incontinence

Enrolled (actual)
445
Serious AEs
3.8%
Results posted
Aug 2017
Primary outcome: Primary: "Much Better" or "Very Much Better" on PGI-I at 3 Months — 80; 72; 59 Participants — p=<0.0492

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Behavioral Therapy (Behavioral); Intravaginal Pessary (Device); Pessary combined with behavioral therapy (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
Female
Sponsor
NICHD Pelvic Floor Disorders Network
Primary completion
Dec 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
"Much Better" or "Very Much Better" on PGI-I at 3 Months
80; 72; 59 <0.0492 sig
PRIMARY
No Bothersome Stress Incontinence Symptoms at 3 Months
66; 71; 49 0.006 sig
SECONDARY
"Much Better" or "Very Much Better" on PGI-I at 12 Months
49; 48; 47 <0.0492 sig
SECONDARY
No Bothersome Stress Incontinence Symptoms at 12 Months.
49; 59; 52 <0.0492 sig
SECONDARY
75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months
80; 68; 69 <0.0492 sig
SECONDARY
75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months
52; 54; 51 <0.0492 sig
SECONDARY
Satisfaction With Treatment at 3 Months
118; 110; 94 0.03 sig
SECONDARY
Satisfaction With Treatment at 12 Months
81; 79; 75 <0.0492 sig

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00270998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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