ATLAS: Ambulatory Treatments for Leakage Associated With Stress
Sponsor
NICHD Pelvic Floor Disorders Network (Other)
Overall Status
Completed
CT.gov ID
NCT00270998
Collaborator
(none)
445
8
3
42
55.6
1.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
445 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date
:
Jun 1, 2005
Actual Primary Completion Date
:
Dec 1, 2008
Actual Study Completion Date
:
Dec 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intravaginal Pessary Pessary restores continence by stabilization of the proximal urethra and urethrovesical junction, facilitating pressure transmission to the proximal urethra. |
Device: Intravaginal Pessary
Intravaginal pessary
|
| Experimental: Behavioral Therapy Pelvic floor muscle training and exercise which includes strong contraction of the pelvic floor muscles to prevent incontinence by occluding the urethra and regular practice can improve pelvic muscle support. |
Behavioral: Behavioral Therapy
Pelvic muscle training and exercises
|
| Experimental: Pessary combined with behavioral therapy Combination of the explanations above. |
Device: Pessary combined with behavioral therapy
Intravaginal pessary and behavioral therapy
|
Outcome Measures
Primary Outcome Measures
- "Much Better" or "Very Much Better" on PGI-I at 3 Months [Outcome was measured at three months following randomization.]
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.
- No Bothersome Stress Incontinence Symptoms at 3 Months [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.
Secondary Outcome Measures
- "Much Better" or "Very Much Better" on PGI-I at 12 Months [Outcome was measured at 12 months following randomization.]
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.
- No Bothersome Stress Incontinence Symptoms at 12 Months. [Outcome was measured at 12 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.
- 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months [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.
- 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months [Outcome was measured at 12 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.
- Satisfaction With Treatment at 3 Months [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.
- Satisfaction With Treatment at 12 Months [Outcome was measured at 12 months following randomization.]
Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama | Birmingham | Alabama | United States | 35249 |
| 2 | University of California, San Diego Medical Center | La Jolla | California | United States | 92037 |
| 3 | Loyola University | Maywood | Illinois | United States | 60153 |
| 4 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 5 | Duke University | Durham | North Carolina | United States | 27710 |
| 6 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 7 | University of Texas Southwestern | Dallas | Texas | United States | 75390 |
| 8 | University of Utah | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- NICHD Pelvic Floor Disorders Network
Investigators
- Study Chair: Holly E Richter, PhD, MD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
Responsible Party:
NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier:
NCT00270998
Other Study ID Numbers:
- PFDN 13
First Posted:
Dec 29, 2005
Last Update Posted:
May 30, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by NICHD Pelvic Floor Disorders Network
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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 Detail |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises |
| Period Title: 3 Month Follow-up | |||
| STARTED | 149 | 146 | 150 |
| COMPLETED | 110 | 124 | 132 |
| NOT COMPLETED | 39 | 22 | 18 |
| Period Title: 3 Month Follow-up | |||
| STARTED | 110 | 124 | 132 |
| COMPLETED | 96 | 99 | 111 |
| NOT COMPLETED | 14 | 25 | 21 |
Baseline Characteristics
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy | Total |
|---|---|---|---|---|
| Arm/Group Description | Intravaginal pessary | Pelvic muscle training and exercises | Treatment includes a combination of both pessary and pelvic muscle exercises | Total of all reporting groups |
| Overall Participants | 149 | 146 | 150 | 445 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
50.2
(11.0)
|
49.6
(13.0)
|
49.5
(11.8)
|
49.8
(11.9)
|
| Sex/Gender, Customized (Count of Participants) | ||||
| Female |
149
100%
|
146
100%
|
150
100%
|
445
100%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White or Caucasian |
126
84.6%
|
132
90.4%
|
122
81.3%
|
380
85.4%
|
| Black or African American |
15
10.1%
|
10
6.8%
|
20
13.3%
|
45
10.1%
|
| Other |
8
5.4%
|
4
2.7%
|
8
5.3%
|
20
4.5%
|
| Vaginal Deliveries (deliveries) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [deliveries] |
2
|
2
|
2
|
2
|
| Menstrual Status (Count of Participants) | ||||
| Pre-menopausal |
75
50.3%
|
71
48.6%
|
68
45.3%
|
214
48.1%
|
| Post-menopausal |
60
40.3%
|
62
42.5%
|
66
44%
|
188
42.2%
|
| Not sure |
14
9.4%
|
13
8.9%
|
16
10.7%
|
43
9.7%
|
| Prior Nonsurgical UI (Count of Participants) | ||||
| Count of Participants [Participants] |
30
20.1%
|
35
24%
|
27
18%
|
92
20.7%
|
| Prior UI Surgery (Count of Participants) | ||||
| Count of Participants [Participants] |
10
6.7%
|
7
4.8%
|
10
6.7%
|
27
6.1%
|
| Hysterectomy (Count of Participants) | ||||
| Count of Participants [Participants] |
39
26.2%
|
39
26.7%
|
32
21.3%
|
110
24.7%
|
| Incontinence Type (Count of Participants) | ||||
| Stress Only |
69
46.3%
|
65
44.5%
|
70
46.7%
|
204
45.8%
|
| Mixed |
80
53.7%
|
81
55.5%
|
80
53.3%
|
241
54.2%
|
| Incontinence Frequency (Count of Participants) | ||||
| 14 or more episodes per wk |
68
45.6%
|
67
45.9%
|
67
44.7%
|
202
45.4%
|
| Fewer than 14 episodes per wk |
81
54.4%
|
79
54.1%
|
83
55.3%
|
243
54.6%
|
| Currently Receiving Estrogen Therapy (Count of Participants) | ||||
| Count of Participants [Participants] |
27
18.1%
|
24
16.4%
|
16
10.7%
|
67
15.1%
|
Outcome Measures
| Title | "Much Better" or "Very Much Better" on PGI-I at 3 Months |
|---|---|
| Description | 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. |
| Time Frame | Outcome was measured at three months following randomization. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal pessary | Pelvic muscle training and exercises | Treatment includes a combination of both pessary and pelvic muscle exercises |
| Measure Participants | 149 | 146 | 150 |
| Count of Participants [Participants] |
80
53.7%
|
72
49.3%
|
59
39.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Behavioral Therapy |
|---|---|---|
| Comments | A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis | |
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | 0.02 |
| Comments | A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis | |
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Behavioral Therapy, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | A priori, the combination treatment was considered superior (75% success rate) to either single-modality therapy (60% success rate) at 80% power with 150 participants per group. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | 0.49 |
| Comments | A priori threshold for statistical significance set at p = 0.0492 to account for interim analysis | |
| Method | Regression, Logistic | |
| Comments | ||
| Title | No Bothersome Stress Incontinence Symptoms at 3 Months |
|---|---|
| Description | 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. |
| Time Frame | Outcome was measured at three months following randomization. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises |
| Measure Participants | 149 | 146 | 150 |
| Count of Participants [Participants] |
66
44.3%
|
71
48.6%
|
49
32.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | 0.048 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Behavioral Therapy, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | 0.42 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | "Much Better" or "Very Much Better" on PGI-I at 12 Months |
|---|---|
| Description | 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. |
| Time Frame | Outcome was measured at 12 months following randomization. |
Outcome Measure Data
| Analysis Population Description |
|---|
| If participant did not attend the 12-month follow-up, missing values were imputed as a failure. |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises |
| Measure Participants | 149 | 146 | 150 |
| Count of Participants [Participants] |
49
32.9%
|
48
32.9%
|
47
31.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Behavioral Therapy, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | No Bothersome Stress Incontinence Symptoms at 12 Months. |
|---|---|
| Description | 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. |
| Time Frame | Outcome was measured at 12 months following randomization. |
Outcome Measure Data
| Analysis Population Description |
|---|
| If participant did not attend the 12-month follow-up, missing values were imputed as a failure. |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises |
| Measure Participants | 149 | 146 | 150 |
| Count of Participants [Participants] |
49
32.9%
|
59
40.4%
|
52
34.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Behavioral Therapy, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | 75% Reduction in Weekly Urinary Incontinence Episodes at 3 Months |
|---|---|
| Description | Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise. |
| Time Frame | Outcome was measured at three months following randomization. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises |
| Measure Participants | 149 | 146 | 150 |
| Count of Participants [Participants] |
80
53.7%
|
68
46.6%
|
69
46%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Behavioral Therapy, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | 75% Reduction in Weekly Urinary Incontinence Episodes at 12 Months |
|---|---|
| Description | Success if participants reported at least 75% reduction in frequency of incontinence episodes on 7-day bladder diary, a failure if they reported otherwise. |
| Time Frame | Outcome was measured at 12 months following randomization. |
Outcome Measure Data
| Analysis Population Description |
|---|
| If participant did not attend the 12-month follow-up, missing values were imputed as a failure. |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises |
| Measure Participants | 149 | 146 | 150 |
| Count of Participants [Participants] |
52
34.9%
|
54
37%
|
51
34%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Behavioral Therapy, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Satisfaction With Treatment at 3 Months |
|---|---|
| Description | Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. |
| Time Frame | Outcome was measured at three months following randomization. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises |
| Measure Participants | 149 | 146 | 150 |
| Count of Participants [Participants] |
118
79.2%
|
110
75.3%
|
94
62.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | 0.03 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | 0.048 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Behavioral Therapy, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
| Title | Satisfaction With Treatment at 12 Months |
|---|---|
| Description | Success if participant reported being "satisfied" on Patient Satisfaction Question (PSQ), a failure if they reported otherwise. |
| Time Frame | Outcome was measured at 12 months following randomization. |
Outcome Measure Data
| Analysis Population Description |
|---|
| If participant did not attend the 12-month follow-up, missing values were imputed as a failure. |
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy |
|---|---|---|---|
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises |
| Measure Participants | 149 | 146 | 150 |
| Count of Participants [Participants] |
81
54.4%
|
79
54.1%
|
75
50%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Pessary, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Behavioral Therapy, Combination of Pessary and Behavioral Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Logistic regression was used to adjust for randomization stratification variables of incontinence type and incontinence severity. No parameter estimates were reported. No adjustments for multiple comparisons made. | |
| Statistical Test of Hypothesis | p-Value | <0.0492 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | ||
Adverse Events
| Time Frame | Adverse events were collected during treatment visits over an 8-week treatment period. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy | |||
| Arm/Group Description | Intravaginal incontinence pessary | Pelvic muscle training and exercises | Treatment is a combination of both pessary and pelvic muscle exercises | |||
All Cause Mortality |
||||||
| Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/149 (4.7%) | 4/146 (2.7%) | 6/150 (4%) | |||
| Cardiac disorders | ||||||
| Angioplasty of heart | 1/149 (0.7%) | 1 | 0/146 (0%) | 0 | 1/150 (0.7%) | 1 |
| Gastrointestinal disorders | ||||||
| Cholecystectomy | 0/149 (0%) | 0 | 2/146 (1.4%) | 2 | 0/150 (0%) | 0 |
| Hiatal hernia repair | 1/149 (0.7%) | 1 | 0/146 (0%) | 0 | 0/150 (0%) | 0 |
| Left femoral hernia | 1/149 (0.7%) | 1 | 0/146 (0%) | 0 | 0/150 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Fractured right leg and ankle | 1/149 (0.7%) | 1 | 0/146 (0%) | 0 | 0/150 (0%) | 0 |
| Lumbar decompression surgery | 1/149 (0.7%) | 1 | 0/146 (0%) | 0 | 0/150 (0%) | 0 |
| Right knee surgery | 0/149 (0%) | 0 | 1/146 (0.7%) | 1 | 0/150 (0%) | 0 |
| Nervous system disorders | ||||||
| Left eye surgery for cancer | 0/149 (0%) | 0 | 0/146 (0%) | 0 | 1/150 (0.7%) | 1 |
| Non-cardiac chest pain and anxiety | 0/149 (0%) | 0 | 0/146 (0%) | 0 | 1/150 (0.7%) | 1 |
| Renal and urinary disorders | ||||||
| Urinary incontinence surgery | 2/149 (1.3%) | 2 | 0/146 (0%) | 0 | 2/150 (1.3%) | 2 |
| Kidney surgery | 0/149 (0%) | 0 | 0/146 (0%) | 0 | 1/150 (0.7%) | 1 |
| Uterine cancer | 0/149 (0%) | 0 | 0/146 (0%) | 0 | 1/150 (0.7%) | 1 |
| Reproductive system and breast disorders | ||||||
| Oophorectomy | 1/149 (0.7%) | 1 | 0/146 (0%) | 0 | 0/150 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pneumonia | 1/149 (0.7%) | 1 | 0/146 (0%) | 0 | 0/150 (0%) | 0 |
| Vascular disorders | ||||||
| Deep vein thrombosis | 0/149 (0%) | 0 | 1/146 (0.7%) | 1 | 0/150 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Pessary | Behavioral Therapy | Combination of Pessary and Behavioral Therapy | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/149 (0%) | 0/146 (0%) | 0/150 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
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 |
| mgantz@rti.org |
Responsible Party:
NICHD Pelvic Floor Disorders Network
ClinicalTrials.gov Identifier:
NCT00270998
Other Study ID Numbers:
- PFDN 13
First Posted:
Dec 29, 2005
Last Update Posted:
May 30, 2018
Last Verified:
Apr 1, 2018