Behavioral Treatment of Overactive Bladder in Men

NCT ID: NCT01187498

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-10-31

Brief Summary

The primary purpose of this project is to evaluate the effectiveness of behavioral treatment compared to standard drug therapy for symptoms of OAB in male veterans.

Detailed Description

Overactive bladder (OAB) is a very common and bothersome condition manifested by urgency, frequent urination, urge urinary incontinence, and nocturia. Drug therapy with oxybutynin or tolterodine is the most common approach to treatment of OAB in VA Medical Center clinics and is the standard of care nationally. Although it improves symptoms of OAB for many patients, drug therapy often has side effects, which cause a significant number of patients to discontinue therapy. Further, many symptoms are not completely controlled, even while patients are on the medication. Therefore, there is a need to improve interventions for this common problem. Although behavioral treatment is a well-established treatment for urge urinary incontinence and frequency in women, there are no controlled trials of behavioral treatment for symptoms of OAB in men. The primary purpose of this project is to evaluate the effectiveness of behavioral treatment for symptoms of OAB in male veterans.

The study is a two-site (Birmingham and Atlanta) randomized clinical trial to evaluate the effects of behavioral training compared to a standard (drug) treatment control condition. Subjects are 143 men with OAB as manifested by urgency and frequent urination (>8 voids per day), with or without incontinence, and without significant bladder outlet obstruction. Following a run-in period in which all patients are treated with an alpha blocker to empirically treat any undetected obstruction, they are stratified on severity and presence of urge incontinence and randomized to 8 weeks of behavioral treatment or drug therapy. The behavioral treatment is a comprehensive, behavioral training program, which includes pelvic floor muscle rehabilitation, self monitoring with bladder diaries, and teaching urge suppression and other skills to inhibit detrusor contraction, thus reducing urgency, frequency, incontinence, and nocturia. Patients in the control group receive standard therapy consisting of individually titrated, extended-release oxybutynin, a well-established pharmacologic agent with a state of the art drug delivery system that has the lowest rates of side effects. Bladder diaries completed by subjects prior to randomization and following the last treatment session are used to calculate changes in frequency of urination, as well as other symptoms of overactive bladder, including reports of urgency, incontinence, and nocturia. Secondary outcome measures include patient global ratings of satisfaction and improvement, impact of incontinence, and the American Urological Association (AUA) Symptom Index.

The second purpose of the study is to examine combined behavioral and drug therapy. Following post-treatment assessment, patients who do not achieve satisfactory outcomes with either behavioral or drug therapy alone are crossed over into a second phase, in which they receive combined treatment to improve outcome as much as possible.

This study will yield important information related to alternative treatment of OAB in male veterans. Though many clinicians use drug therapy routinely in the treatment of OAB, most do not offer behavioral treatments such as pelvic floor muscle training for this problem. Thus, this study has potential to alter standards of care for OAB in men.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Training

Behavioral training using delayed voiding, urge suppression techniques, and pelvic floor muscle training

Group Type: EXPERIMENTAL

Behavioral training

Intervention Type: BEHAVIORAL

Comprehensive behavioral training program using delayed voiding, urge suppression techniques, pelvic floor muscle training, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.

Drug Therapy

Oxybutynin chloride, extended-release, individually-titrated, 5-30 mg

Group Type: ACTIVE_COMPARATOR

Oxybutynin chloride, extended-release

Intervention Type: DRUG

Individually titrated, extended-release oxybutynin chloride, initiated at 10 mg, fluid management handout, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.

Interventions

Behavioral training

Comprehensive behavioral training program using delayed voiding, urge suppression techniques, pelvic floor muscle training, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.

Intervention Type: BEHAVIORAL

Oxybutynin chloride, extended-release

Individually titrated, extended-release oxybutynin chloride, initiated at 10 mg, fluid management handout, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.

Intervention Type: DRUG

Other Intervention Names

Behavioral treatment; Antimuscarinic medication

Eligibility Criteria

Inclusion Criteria

• Male
• Community-dwelling
• Veteran
• Self-reported urgency
• Self-reported frequent urination
• Mean of > 8 voids per 24-hour day on bladder diary
• Able to come to clinic

Exclusion Criteria

• Urologic surgery in the past 6 months
• Nonambulatory (unless has independent transfer skills)
• Flow rate < 5mL at baseline and < 10mL/sec after run-in (on simple uroflowmetry)
• Post-void residual urine volume > 250mL at baseline and > 150mL after run-in (on bladder ultrasound)
• Continual leakage
• Urinary tract infection (growth of > 100,000 colonies per ml of a urinary pathogen on urine culture). May be reconsidered after treatment and negative culture.
• Fecal impaction
• Poorly controlled diabetes (glycosylated hemoglobin >9 within last 3 months)
• Hematuria on microscopic examination in the absence of infection
• Any unstable medical condition (particularly: decompensated congestive heart failure, malignant arrhythmias, unstable angina)

-- Impaired mental status (< 24 on Folstein's Mini-Mental State Exam)

• Narrow angle glaucoma
• Gastric retention (by medical history)
• Hypersensitivity to tamsulosin or oxybutynin
• Current use of anticholinergic agents for detrusor instability. May be reconsidered after 2-week wash-out.
• If on diuretic, dose has not been stable for at least three months
• Sleep apnea, unless surgically corrected

• Minimum Eligible Age: 19 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn L. Burgio, PhD MA BA

Role: PRINCIPAL_INVESTIGATOR

Birmingham, Alabama VA Medical Center

Locations

Birmingham VA Medical Center

Birmingham, Alabama, United States

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, United States

Countries

United States

References

Burgio KL, Goode PS, Johnson TM, Hammontree L, Ouslander JG, Markland AD, Colli J, Vaughan CP, Redden DT. Behavioral versus drug treatment for overactive bladder in men: the Male Overactive Bladder Treatment in Veterans (MOTIVE) Trial. J Am Geriatr Soc. 2011 Dec;59(12):2209-16. doi: 10.1111/j.1532-5415.2011.03724.x. Epub 2011 Nov 7.

Reference Type: RESULT

PMID: 22092152 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37811598 (View on PubMed)

Johnson TM 2nd, Markland AD, Goode PS, Vaughan CP, Colli JL, Ouslander JG, Redden DT, McGwin G, Burgio KL. Efficacy of adding behavioural treatment or antimuscarinic drug therapy to alpha-blocker therapy in men with nocturia. BJU Int. 2013 Jul;112(1):100-8. doi: 10.1111/j.1464-410X.2012.11736.x. Epub 2013 Feb 28.

Reference Type: DERIVED

PMID: 23448285 (View on PubMed)

Other Identifiers

B3083-R

Identifier Type: -

Identifier Source: org_study_id