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ATLAS: Ambulatory Treatments for Leakage Associated With Stress

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00270998
First Posted: December 29, 2005
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
dwallace, NICHD Pelvic Floor Disorders Network
Results First Submitted: April 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Stress Urinary Incontinence
Urinary Incontinence
Interventions: Behavioral: Behavioral Therapy
Device: Intravaginal Pessary
Device: Pessary combined with behavioral therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
740 women were screened for symptoms of stress only or mixed incontinence symptoms and age of at least 18 years old. 294 did not meet inclusion criteria, one refused to participate and 445 were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pessary Intravaginal incontinence pessary
Behavioral Therapy Pelvic muscle training and exercises
Combination of Pessary and Behavioral Therapy Treatment is a combination of both pessary and pelvic muscle exercises

Participant Flow for 2 periods

Period 1:   3 Month Follow-up
    Pessary   Behavioral Therapy   Combination of Pessary and Behavioral Therapy
STARTED   149   146   150 [1] 
COMPLETED   110   124   132 
NOT COMPLETED   39   22   18 
Adverse Event                1                0                0 
Lack of Efficacy                1                2                1 
Withdrawal by Subject                11                14                15 
Pessary did not fit                12                0                0 
Personal/family health                1                1                0 
Received/desired alternate treatment                13                5                2 
[1] 1 participant randomized to combined found ineligible at first treatment visit, removed from study.

Period 2:   12 Month Follow-up
    Pessary   Behavioral Therapy   Combination of Pessary and Behavioral Therapy
STARTED   110   124   132 
COMPLETED   96   99   111 
NOT COMPLETED   14   25   21 
Lack of Efficacy                5                4                3 
Withdrawal by Subject                7                12                16 
Pessary did not fit                1                0                0 
Personal/family health                0                5                1 
Received/desired alternate treatment                1                4                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pessary Intravaginal pessary
Behavioral Therapy Pelvic muscle training and exercises
Combination of Pessary and Behavioral Therapy Treatment includes a combination of both pessary and pelvic muscle exercises
Total Total of all reporting groups

Baseline Measures
   Pessary   Behavioral Therapy   Combination of Pessary and Behavioral Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   146   150   445 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.2  (11.0)   49.6  (13.0)   49.5  (11.8)   49.8  (11.9) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
       
Female   149   146   150   445 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
White or Caucasian   126   132   122   380 
Black or African American   15   10   20   45 
Other   8   4   8   20 
Vaginal Deliveries 
[Units: Deliveries]
Median (Inter-Quartile Range)
 2 
 (1 to 3) 
 2 
 (1 to 3) 
 2 
 (1 to 3) 
 2 
 (1 to 3) 
Menstrual Status 
[Units: Participants]
Count of Participants
       
Pre-menopausal   75   71   68   214 
Post-menopausal   60   62   66   188 
Not sure   14   13   16   43 
Prior Nonsurgical UI 
[Units: Participants]
Count of Participants
 30   35   27   92 
Prior UI Surgery 
[Units: Participants]
Count of Participants
 10   7   10   27 
Hysterectomy 
[Units: Participants]
Count of Participants
 39   39   32   110 
Incontinence Type 
[Units: Participants]
Count of Participants
       
Stress Only   69   65   70   204 
Mixed   80   81   80   241 
Incontinence Frequency 
[Units: Participants]
Count of Participants
       
14 or more episodes per wk   68   67   67   202 
Fewer than 14 episodes per wk   81   79   83   243 
Currently Receiving Estrogen Therapy 
[Units: Participants]
Count of Participants
 27   24   16   67 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   “Much Better” or “Very Much Better” on PGI-I at 3 Months   [ Time Frame: Outcome was measured at three months following randomization. ]

2.  Primary:   No Bothersome Stress Incontinence Symptoms at 3 Months   [ Time Frame: Outcome was measured at three months following randomization. ]

3.  Secondary:   “Much Better” or “Very Much Better” on PGI-I at 12 Months   [ Time Frame: Outcome was measured at 12 months following randomization. ]

4.  Secondary:   No Bothersome Stress Incontinence Symptoms at 12 Months.   [ Time Frame: Outcome was measured at 12 months following randomization. ]

5.  Secondary:   75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months   [ Time Frame: Outcome was measured at three months following randomization. ]

6.  Secondary:   75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months   [ Time Frame: Outcome was measured at 12 months following randomization. ]

7.  Secondary:   Satisfaction With Treatment at 3 Months   [ Time Frame: Outcome was measured at three months following randomization. ]

8.  Secondary:   Satisfaction With Treatment at 12 Months   [ Time Frame: Outcome was measured at 12 months following randomization. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marie Gantz
Organization: RTI International
phone: 919-597-5110
e-mail: mgantz@rti.org


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: dwallace, NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier: NCT00270998     History of Changes
Other Study ID Numbers: PFDN 13
First Submitted: December 27, 2005
First Posted: December 29, 2005
Results First Submitted: April 18, 2017
Results First Posted: August 10, 2017
Last Update Posted: September 20, 2017