Enhancing Conservative Treatment for Urge Incontinence

NCT00223821 | Completed Results

• 1 other identifier: B2899-R
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

Behavior Therapy; Behavioral Medicine; Behavioral Research; Behavioral Sciences; Combined Modality Therapy; Drug Therapy; Overactive bladder; Treatment Outcome; Urge incontinence; Urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and immediately post-treatment - week 8

Secondary Outcomes (1)

• Change in Incontinent Episodes at 12-month Follow-up

  Baseline and 12 months post-treatment

Study Arms (2)

Drug Therapy Aone

ACTIVE COMPARATOR

Oxybutynin chloride, extended-release, individually-titrated

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.

Drug: Oxybutynin chloride, extended-release, individually-titrated; Behavioral: Behavior Training

Interventions

Oxybutynin chloride, extended-release, individually-titrated DRUG

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

Also known as: Ditropan XL

Drug Therapy + Behavioral Training; Drug Therapy Aone

Behavior Training BEHAVIORAL

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

Drug Therapy + Behavioral Training

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

Location

Related Publications (2)

• 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.

  PMID: 20639023 RESULT

• Funada 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.

  PMID: 37811598 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

oxybutynin; Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Limitations and Caveats

Secondary objectives could not be achieved because, based on a conditional power calculation, the trial was stopped early for futility.

Results Point of Contact

• Title: Kathryn L. Burgio, PhD
• Organization: Birmingham VA Medical Center

kburgio@uabmc.edu

205-558-7064

Study Officials

• Kathryn L. Burgio, PhD MA BA

  Birmingham, Alabama VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2009
• Last Updated: December 19, 2013
• Results First Posted: December 19, 2013

Record last verified: 2013-10

Locations

US (1)