Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Conservative Treatment for Urge Incontinence (COMBO)

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.
 
ClinicalTrials.gov Identifier: NCT00223821
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urinary Incontinence
Interventions Drug: Oxybutynin chloride, extended-release, individually-titrated
Behavioral: Behavior Training
Enrollment 166
Recruitment Details Participants were community-dwelling women with urge predominant incontinence recruited between July 2003 and January 2008.
Pre-assignment Details Of the 166 women enrolled, 58 were found to be ineligible on clinical evaluation, 44 withdrew, and 64 were randomized.
Arm/Group Title Drug Therapy Alone Drug Therapy + Behavioral Training
Hide Arm/Group Description

drug therapy alone

Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.

drug therapy + behavioral training

Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.

Behavior Training: Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.

Period Title: Overall Study
Started 32 32
Completed Therapy 31 28
Completed Post-treatment Assessment 31 27
Completed 6-month Follow-up 28 25
Completed 28 22
Not Completed 4 10
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

drug therapy alone

Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.

drug therapy + behavioral training

Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.

Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.

Total of all reporting groups
Overall Number of Baseline Participants 32 32 64
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 32 participants 64 participants
59.3  (11.2) 57.4  (12.6) 58.4  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Female
32
 100.0%
32
 100.0%
64
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
32
 100.0%
32
 100.0%
64
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  18.8%
14
  43.8%
20
  31.3%
White
26
  81.3%
18
  56.3%
44
  68.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 32 participants 64 participants
32 32 64
Incontinence type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Urge only 25 26 51
Mixed urge + stress 7 5 12
missing 0 1 1
Incontinence severity  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 32 participants 32 participants 64 participants
Mild (less than 5 episodes/wk) 4 4 8
Moderate (5-10 episodes/wk) 7 10 17
Severe (> 10 episodes/wk) 21 18 39
1.Primary Outcome
Title Change in Incontinent Episodes Immediately Post-treatment
Hide Description Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.
Time Frame Baseline and immediately post-treatment - week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Drug Therapy Alone Drug Therapy + Behavioral Training
Hide Arm/Group Description:
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.

Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.

Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percentage change
-88.5  (24.0) -78.3  (32.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drug Therapy Alone, Drug Therapy + Behavioral Training
Comments The effectiveness of each intervention was calculated by comparing the weekly frequency of incontinent episodes (derived from seven-day bladder diaries) during baseline to that in the immediate post-intervention period (week 8). The primary analysis was based on intent-to-treat, in which post-treatment frequency of incontinence for non-completers was derived from the most recent week of diaries.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .16
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.2
Confidence Interval (2-Sided) 95%
-5.13 to 25.54
Parameter Dispersion
Type: Standard Error of the mean
Value: 7.65
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Incontinent Episodes at 12-month Follow-up
Hide Description Percent change from baseline in weekly frequency of incontinent episodes at 12-months post-treatment, derived from baseline and 12-month seven-day bladder diaries
Time Frame Baseline and 12 months post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Drug Therapy Alone Drug Therapy + Behavioral Training
Hide Arm/Group Description:
Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.

Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.

Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.

Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: percent change
-82.0  (26.1) -75.2  (33.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drug Therapy Alone, Drug Therapy + Behavioral Training
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .37
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA, with baseline frequency of incontinent episodes as the covariate, was used to compare the treatment groups.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
-10.73 to 24.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.71
Estimation Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

drug therapy alone

Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.

drug therapy + behavioral training

Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.

Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.

All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Secondary objectives could not be achieved because, based on a conditional power calculation, the trial was stopped early for futility.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathryn L. Burgio, PhD
Organization: Birmingham VA Medical Center
Phone: 205-558-7064
EMail: kburgio@uabmc.edu
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00223821    
Other Study ID Numbers: B2899-R
First Submitted: September 14, 2005
First Posted: September 22, 2005
Results First Submitted: October 11, 2013
Results First Posted: December 19, 2013
Last Update Posted: December 19, 2013