Urinary IncontinenceCOMBONCT00223821
Enhancing Conservative Treatment for Urge Incontinence
A study testing Oxybutynin chloride, extended-release, individually-titrated and Behavior Training in people with Urinary Incontinence, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Oxybutynin chloride, extended-release, individually-titrated and Behavior Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants in this study were ambulatory, community-dwelling women (veterans and nonveterans) with persistent urge or predominantly urge incontinence.
- Participants must:
- Be ambulatory.
- Be able to come to the clinic for treatment.
- Report urge incontinence.
- Report incontinence occurring at least twice per week on average.
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- Report incontinence persisting for at least three months.
- Not have received behavioral therapy in the University of Alabama at Birmingham (UAB) Continence Clinic or Department of Veterans Affairs (VA) Continence Clinic.
- In the clinical interview, the subject must report involuntary loss of urine associated with a strong desire to void and that the condition has persisted for at least three months.
- At least two urge accidents on the 7-day baseline bladder diary, and the number of urge accidents must exceed the number of other types of accidents.
- On urodynamic evaluation, there must be cystometric evidence of bladder dysfunction, either: detrusor instability or maximal cystometric capacity is less than 400 ml.
Who cannot join
- Continual leakage.
- Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture).
- Fecal impaction.
- Uncontrolled metabolic problem.
- Post-void residual volume > 150 ml.
- Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on agreement between the urologist and geriatrician (co-PI) that entry into treatment protocol is not contraindicated.
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- Severe uterine prolapse (prolapse reaching the vaginal introitus).
- Decompensated congestive heart failure, diagnosed by history or physical exam.
- Impaired mental status. (<24 on Folstein's Mini-Mental State Exam).
- Uncontrolled narrow angle glaucoma.
- Gastric retention (by medical history).
- Hypersensitivity to oxybutynin.
- Current use of anticholinergic agents for detrusor instability. Subjects on these medications will be asked to discontinue them for the duration of the study. Evaluation will be delayed until the drug(s) have been discontinued for 2 weeks.
- If on diuretic, dose stable for less than three months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Birmingham VA Medical Center
Birmingham, Alabama, 35233
About this study
The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.
Read the detailed description
Urinary incontinence in women is a major problem with significant medical, psychological, and social consequences. Previous research on urge incontinence, a common form of incontinence, has demonstrated that behavioral and drug interventions are effective, but do not cure most patients. Thus there is a need to improve conservative treatment for urge incontinence in women. The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women. This project is a randomized controlled clinical trial. Sixty-four women with predominantly urge incontinence have been randomized. Stratification and blocked randomization procedures are used to assign a subject to 8 weeks of drug therapy alone or 8 weeks of drug therapy enhanced with components of behavioral training that can be administered in most any outpatient clinic. The drug therapy is extended release oxybutynin, a well-established pharmacologic agent with a state of the art drug delivery system that has the lowest rates of side-effect. The behavioral treatment is an innovative, comprehensive, behavioral training program, which includes pelvic floor muscle rehabilitation, teaching urge suppression and other skills to improve bladder control, and self-monitoring with bladder diaries. Bladder diaries completed by subjects before and after the treatment are used to calculate reduction in the frequency of incontinence. Secondary outcomes measures include a patient satisfaction questionnaire and three impact/quality of life measures (Incontinence Impact Questionnaire, Uro-Genital Distress Index, SF-12 Health Survey). The second objective of the study is to examine the cost-effectiveness of adding behavioral components to drug therapy. With the changing health care environment, there is increased concern with the costs of providing treatment. This project will compare the relative costs and value of combined intervention using the methods of cost-effectiveness analysis, the most widely adopted method for the economic evaluation of health interventions. The third objective of the study is to examine further the mechanisms by which these therapies reduce incontinence, including changes in bladder capacity, thresholds for bladder sensation, pelvic muscle strength, use of pelvic muscles in response to the sensation of urgency and frequency of urination. Pre-post changes in these parameters are measured to examine the effects of the treatment on these variables, and structural equation modeling will be used to examine whether changes in each of these measures are related to treatment outcome.
- Conditions
- Urinary Incontinence
- Being tested
- Oxybutynin chloride, extended-release, individually-titrated, Behavior Training
- Keywords
- Behavior Therapy, Behavioral Medicine, Behavioral Research, Behavioral Sciences, Combined Modality Therapy, Drug Therapy, Overactive bladder, Treatment Outcome, Urge incontinence, Urinary incontinence
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin chloride, extended-release, individually-titratedDrug
Also called Ditropan XL
Individually-titrated, extended-release oxybutynin chloride with management of side-effects.
Behavior TrainingBehavioural
Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
| Study group | Role | What they receive |
|---|---|---|
| Drug Therapy Aone | Active comparator | Oxybutynin chloride, extended-release, individually-titrated Receives: Drug: Oxybutynin chloride, extended-release, individually-titrated |
| Drug Therapy + Behavioral Training | Experimental | Drug Therapy + Behavioral Training: Individually-titrated, extended-release oxybutynin chloride with management of side-effects. Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training. Receives: Drug: Oxybutynin chloride, extended-release, individually-titrated; Behavioral: Behavior Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Incontinent Episodes Immediately Post-treatment
Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.
Measured: Baseline and immediately post-treatment - week 8
Secondary outcomes (1)
Change in Incontinent Episodes at 12-month Follow-up
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
Measured: Baseline and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionNov 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kathryn L. Burgio, PhD MA BA, Principal investigator, Birmingham, Alabama VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223821
- Sponsor's protocol ID
- B2899-R
- Acronym
- COMBO
- Status last verified
- Oct 2013
- First submitted
- 14 Sep 2005
- Last updated
- 19 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Burgio KL, Goode PS, Richter HE, Markland AD, Johnson TM 2nd, Redden DT. Combined behavioral and individualized drug therapy versus individualized drug therapy alone for urge urinary incontinence in women. J Urol. 2010 Aug;184(2):598-603. doi: 10.1016/j.juro.2010.03.141. Epub 2010 Jun 19.
PubMed 20639023Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
PubMed 37811598
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Conservative Treatment for Urge Incontinence
- ClinicalTrials.gov ID
- NCT00223821
- Acronym / sponsor ID
- COMBO / B2899-R
- Conditions
- Urinary Incontinence
- Keywords
- Behavior Therapy, Behavioral Medicine, Behavioral Research, Behavioral Sciences, Combined Modality Therapy, Drug Therapy, Overactive bladder, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 19 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women.
Detailed description
Urinary incontinence in women is a major problem with significant medical, psychological, and social consequences. Previous research on urge incontinence, a common form of incontinence, has demonstrated that behavioral and drug interventions are effective, but do not cure most patients. Thus there is a need to improve conservative treatment for urge incontinence in women. The primary objective of this project is to evaluate whether enhancing drug therapy with components of behavioral training, including pelvic floor muscle rehabilitation, results in better outcomes than drug therapy alone for urge incontinence in community-dwelling women. This project is a randomized controlled clinical trial. Sixty-four women with predominantly urge incontinence have been randomized. Stratification and blocked randomization procedures are used to assign a subject to 8 weeks of drug therapy alone or 8 weeks of drug therapy enhanced with components of behavioral training that can be administered in most any outpatient clinic. The drug therapy is extended release oxybutynin, a well-established pharmacologic agent with a state of the art drug delivery system that has the lowest rates of side-effect. The behavioral treatment is an innovative, comprehensive, behavioral training program, which includes pelvic floor muscle rehabilitation, teaching urge suppression and other skills to improve bladder control, and self-monitoring with bladder diaries. Bladder diaries completed by subjects before and after the treatment are used to calculate reduction in the frequency of incontinence. Secondary outcomes measures include a patient satisfaction questionnaire and three impact/quality of life measures (Incontinence Impact Questionnaire, Uro-Genital Distress Index, SF-12 Health Survey). The second objective of the study is to examine the cost-effectiveness of adding behavioral components to drug therapy. With the changing health care environment, there is increased concern with the costs of providing treatment. This project will compare the relative costs and value of combined intervention using the methods of cost-effectiveness analysis, the most widely adopted method for the economic evaluation of health interventions. The third objective of the study is to examine further the mechanisms by which these therapies reduce incontinence, including changes in bladder capacity, thresholds for bladder sensation, pelvic muscle strength, use of pelvic muscles in response to the sensation of urgency and frequency of urination. Pre-post changes in these parameters are measured to examine the effects of the treatment on these variables, and structural equation modeling will be used to examine whether changes in each of these measures are related to treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Therapy Aone | Active comparator | Drug: Oxybutynin chloride, extended-release, individually-titratedOxybutynin chloride, extended-release, individually-titrated |
| Drug Therapy + Behavioral Training | Experimental | Drug: Oxybutynin chloride, extended-release, individually-titrated, Behavioral: Behavior TrainingDrug Therapy + Behavioral Training: Individually-titrated, extended-release oxybutynin chloride with management of side-effects. Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants in this study were ambulatory, community-dwelling women (veterans and nonveterans) with persistent urge or predominantly urge incontinence.
- Be ambulatory.
- Be able to come to the clinic for treatment.
- Report urge incontinence.
- Report incontinence occurring at least twice per week on average.
Key exclusion criteria (14 listed)
- Continual leakage.
- Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture).
- Fecal impaction.
- Uncontrolled metabolic problem.
- Post-void residual volume > 150 ml.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybutynin chloride, extended-release, individually-titratedAlso: Ditropan XLIndividually-titrated, extended-release oxybutynin chloride with management of side-effects. | Drug | Drug Therapy + Behavioral Training, Drug Therapy Aone |
| Behavior TrainingBehavioral training consists of teaching urge suppression strategies and pelvic floor muscle training. | Behavioural | Drug Therapy + Behavioral Training |
Primary outcome
Change in Incontinent Episodes Immediately Post-treatment
Time frame: Baseline and immediately post-treatment - week 8
Percent change from baseline in weekly frequency of incontinent episodes immediately post-treatment, derived from baseline and week 8 seven-day bladder diaries.
1 secondary outcome
Change in Incontinent Episodes at 12-month Follow-up
Time frame: Baseline and 12 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20639023Burgio KL, Goode PS, Richter HE, Markland AD, Johnson TM 2nd, Redden DT. Combined behavioral and individualized drug therapy versus individualized drug therapy alone for urge urinary incontinence in women. J Urol. 2010 Aug;184(2):598-603. doi: 10.1016/j.juro.2010.03.141. Epub 2010 Jun 19.
- Derived from this study: PubMed 37811598Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn L. Burgio, PhD MA BA principal investigator
Birmingham, Alabama VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxybutynin chloride, extended-release, individually-titrated and Behavior Training in people with Urinary Incontinence, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Incontinent Episodes Immediately Post-treatment (time frame: Baseline and immediately post-treatment - week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00223821, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.