Trial Outcomes & Findings for ATLAS: Ambulatory Treatments for Leakage Associated With Stress (NCT NCT00270998)

Last Updated: 2018-05-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

445 participants

Primary outcome timeframe

Outcome was measured at three months following randomization.

Results posted on

2018-05-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
3 Month Follow-up STARTED	149	146	150
3 Month Follow-up COMPLETED	110	124	132
3 Month Follow-up NOT COMPLETED	39	22	18
12 Month Follow-up STARTED	110	124	132
12 Month Follow-up COMPLETED	96	99	111
12 Month Follow-up NOT COMPLETED	14	25	21

Reasons for withdrawal

Reasons for withdrawal
Measure	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
3 Month Follow-up Adverse Event	1	0	0
3 Month Follow-up Lack of Efficacy	1	2	1
3 Month Follow-up Withdrawal by Subject	11	14	15
3 Month Follow-up Pessary did not fit	12	0	0
3 Month Follow-up Personal/family health	1	1	0
3 Month Follow-up Received/desired alternate treatment	13	5	2
12 Month Follow-up Lack of Efficacy	5	4	3
12 Month Follow-up Withdrawal by Subject	7	12	16
12 Month Follow-up Pessary did not fit	1	0	0
12 Month Follow-up Personal/family health	0	5	1
12 Month Follow-up Received/desired alternate treatment	1	4	1

Baseline Characteristics

ATLAS: Ambulatory Treatments for Leakage Associated With Stress

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises	Total n=445 Participants Total of all reporting groups
Age, Continuous	50.2 years STANDARD_DEVIATION 11.0 • n=5 Participants	49.6 years STANDARD_DEVIATION 13.0 • n=7 Participants	49.5 years STANDARD_DEVIATION 11.8 • n=5 Participants	49.8 years STANDARD_DEVIATION 11.9 • n=4 Participants
Sex/Gender, Customized Female	149 Participants n=5 Participants	146 Participants n=7 Participants	150 Participants n=5 Participants	445 Participants n=4 Participants
Race/Ethnicity, Customized White or Caucasian	126 Participants n=5 Participants	132 Participants n=7 Participants	122 Participants n=5 Participants	380 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	15 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants	45 Participants n=4 Participants
Race/Ethnicity, Customized Other	8 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Vaginal Deliveries	2 deliveries n=5 Participants	2 deliveries n=7 Participants	2 deliveries n=5 Participants	2 deliveries n=4 Participants
Menstrual Status Pre-menopausal	75 Participants n=5 Participants	71 Participants n=7 Participants	68 Participants n=5 Participants	214 Participants n=4 Participants
Menstrual Status Post-menopausal	60 Participants n=5 Participants	62 Participants n=7 Participants	66 Participants n=5 Participants	188 Participants n=4 Participants
Menstrual Status Not sure	14 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	43 Participants n=4 Participants
Prior Nonsurgical UI	30 Participants n=5 Participants	35 Participants n=7 Participants	27 Participants n=5 Participants	92 Participants n=4 Participants
Prior UI Surgery	10 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Hysterectomy	39 Participants n=5 Participants	39 Participants n=7 Participants	32 Participants n=5 Participants	110 Participants n=4 Participants
Incontinence Type Stress Only	69 Participants n=5 Participants	65 Participants n=7 Participants	70 Participants n=5 Participants	204 Participants n=4 Participants
Incontinence Type Mixed	80 Participants n=5 Participants	81 Participants n=7 Participants	80 Participants n=5 Participants	241 Participants n=4 Participants
Incontinence Frequency 14 or more episodes per wk	68 Participants n=5 Participants	67 Participants n=7 Participants	67 Participants n=5 Participants	202 Participants n=4 Participants
Incontinence Frequency Fewer than 14 episodes per wk	81 Participants n=5 Participants	79 Participants n=7 Participants	83 Participants n=5 Participants	243 Participants n=4 Participants
Currently Receiving Estrogen Therapy	27 Participants n=5 Participants	24 Participants n=7 Participants	16 Participants n=5 Participants	67 Participants n=4 Participants

PRIMARY outcome

Timeframe: Outcome was measured at three months following randomization.

Population: If participant did not attend the three-month follow-up, missing values were imputed by either the value from the next available follow-up or if the participant was lost to follow-up the participant was treated as a failure.

Outcome measures

Outcome measures
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises
"Much Better" or "Very Much Better" on PGI-I at 3 Months	80 Participants	72 Participants	59 Participants

PRIMARY outcome

Timeframe: Outcome was measured at three months following randomization.

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 measures

Outcome measures
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises
No Bothersome Stress Incontinence Symptoms at 3 Months	66 Participants	71 Participants	49 Participants

SECONDARY outcome

Timeframe: Outcome was measured at 12 months following randomization.

Population: If participant did not attend the 12-month follow-up, missing values were imputed as a failure.

Outcome measures

Outcome measures
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises
"Much Better" or "Very Much Better" on PGI-I at 12 Months	49 Participants	48 Participants	47 Participants

SECONDARY outcome

Timeframe: Outcome was measured at 12 months following randomization.

Population: If participant did not attend the 12-month follow-up, missing values were imputed as a failure.

Outcome measures

Outcome measures
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises
No Bothersome Stress Incontinence Symptoms at 12 Months.	49 Participants	59 Participants	52 Participants

SECONDARY outcome

Timeframe: Outcome was measured at three months following randomization.

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 measures

Outcome measures
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises
75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months	80 Participants	68 Participants	69 Participants

SECONDARY outcome

Timeframe: Outcome was measured at 12 months following randomization.

Population: If participant did not attend the 12-month follow-up, missing values were imputed as a failure.

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 measures

Outcome measures
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises
75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months	52 Participants	54 Participants	51 Participants

SECONDARY outcome

Timeframe: Outcome was measured at three months following randomization.

Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.

Outcome measures

Outcome measures
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises
Satisfaction With Treatment at 3 Months	118 Participants	110 Participants	94 Participants

SECONDARY outcome

Timeframe: Outcome was measured at 12 months following randomization.

Population: If participant did not attend the 12-month follow-up, missing values were imputed as a failure.

Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.

Outcome measures

Outcome measures
Measure	Pessary n=149 Participants Intravaginal pessary	Behavioral Therapy n=146 Participants Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 Participants Treatment includes a combination of both pessary and pelvic muscle exercises
Satisfaction With Treatment at 12 Months	81 Participants	79 Participants	75 Participants

Adverse Events

Pessary

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral Therapy

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Combination of Pessary and Behavioral Therapy

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Marie Gantz

RTI International

Phone: 919-597-5110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Pessary n=149 participants at risk Intravaginal incontinence pessary	Behavioral Therapy n=146 participants at risk Pelvic muscle training and exercises	Combination of Pessary and Behavioral Therapy n=150 participants at risk Treatment is a combination of both pessary and pelvic muscle exercises
Renal and urinary disorders Urinary incontinence surgery	1.3% 2/149 • Number of events 2 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	1.3% 2/150 • Number of events 2 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Gastrointestinal disorders Cholecystectomy	0.00% 0/149 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	1.4% 2/146 • Number of events 2 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Cardiac disorders Angioplasty of heart	0.67% 1/149 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.67% 1/150 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Vascular disorders Deep vein thrombosis	0.00% 0/149 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.68% 1/146 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Gastrointestinal disorders Hiatal hernia repair	0.67% 1/149 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Gastrointestinal disorders Left femoral hernia	0.67% 1/149 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Nervous system disorders Left eye surgery for cancer	0.00% 0/149 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.67% 1/150 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Nervous system disorders Non-cardiac chest pain and anxiety	0.00% 0/149 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.67% 1/150 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Reproductive system and breast disorders Oophorectomy	0.67% 1/149 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.67% 1/149 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Musculoskeletal and connective tissue disorders Fractured right leg and ankle	0.67% 1/149 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Musculoskeletal and connective tissue disorders Lumbar decompression surgery	0.67% 1/149 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Musculoskeletal and connective tissue disorders Right knee surgery	0.00% 0/149 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.68% 1/146 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/150 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Renal and urinary disorders Kidney surgery	0.00% 0/149 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.67% 1/150 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.
Renal and urinary disorders Uterine cancer	0.00% 0/149 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.00% 0/146 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.	0.67% 1/150 • Number of events 1 • Adverse events were collected during treatment visits over an 8-week treatment period. As no other adverse events, those that don't meet the definition of a SAE, occurred in at least 5% of participants in any one of the three arms for the ATLAS trial, no table was generated as it is not required by law.