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Enhancing Conservative Treatment for Urge Incontinence (COMBO)

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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 )

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 22, 2005
Results First Submitted Date  ICMJE October 11, 2013
Results First Posted Date  ICMJE December 19, 2013
Last Update Posted Date December 19, 2013
Study Start Date  ICMJE September 2003
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Reduction of incontinence episodes derived from bladder diaries immediately post-treatment and at 6 months and 12 months post-treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2013)
Change in Incontinent Episodes at 12-month Follow-up [ Time Frame: Baseline and 12 months post-treatment ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
Patient self-report (Patient Satisfaction Questionnaire) and 3 impact/quality of life measures (Incontinence Impact Questionnaire, Uro-Genital Distress Index, SF-36 Health Survey) immediately post-treatment and at 6 months and 12 months post-treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Conservative Treatment for Urge Incontinence
Official Title  ICMJE Enhancing Conservative Treatment for Urge Incontinence
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE
  • Drug: Oxybutynin chloride, extended-release, individually-titrated
    Individually-titrated, extended-release oxybutynin chloride with management of side-effects.
    Other Name: Ditropan XL
  • Behavioral: Behavior Training
    Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training.
Study Arms  ICMJE
  • Active Comparator: Drug Therapy Aone
    Oxybutynin chloride, extended-release, individually-titrated
    Intervention: Drug: Oxybutynin chloride, extended-release, individually-titrated
  • Experimental: Drug Therapy + Behavioral Training
    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.
    Interventions:
    • Drug: Oxybutynin chloride, extended-release, individually-titrated
    • Behavioral: Behavior Training
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2009)
166
Original Enrollment  ICMJE
 (submitted: September 14, 2005)
300
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participants in this study were ambulatory, community-dwelling women (veterans and nonveterans) with persistent urge or predominantly urge incontinence.

Participants must:

  1. Be ambulatory.
  2. Be able to come to the clinic for treatment.
  3. Report urge incontinence.
  4. Report incontinence occurring at least twice per week on average.
  5. Report incontinence persisting for at least three months.
  6. Not have received behavioral therapy in the University of Alabama at Birmingham (UAB) Continence Clinic or Department of Veterans Affairs (VA) Continence Clinic.
  7. 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.
  8. 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.
  9. On urodynamic evaluation, there must be cystometric evidence of bladder dysfunction, either: detrusor instability or maximal cystometric capacity is less than 400 ml.

Exclusion Criteria:

  1. Continual leakage.
  2. Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture).
  3. Fecal impaction.
  4. Uncontrolled metabolic problem.
  5. Post-void residual volume > 150 ml.
  6. 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.
  7. Severe uterine prolapse (prolapse reaching the vaginal introitus).
  8. Decompensated congestive heart failure, diagnosed by history or physical exam.
  9. Impaired mental status. (<24 on Folstein's Mini-Mental State Exam).
  10. Uncontrolled narrow angle glaucoma.
  11. Gastric retention (by medical history).
  12. Hypersensitivity to oxybutynin.
  13. 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.
  14. If on diuretic, dose stable for less than three months.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00223821
Other Study ID Numbers  ICMJE B2899-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathryn L. Burgio, PhD MA BA Birmingham, Alabama VA Medical Center
PRS Account VA Office of Research and Development
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP