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Combined Behavioral and Drug Treatment of Overactive Bladder in Men (COBALT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01175382
First received: August 3, 2010
Last updated: August 5, 2014
Last verified: November 2013
  Purpose

The primary aim of this project is to evaluate the effectiveness of combined behavioral + drug therapy compared to behavioral treatment alone and drug therapy alone as a way to improve outcomes in the treatment of OAB symptoms in men. We hypothesize that combined therapy will result in better outcomes than either behavioral or drug therapy alone. The second aim is to compare two methods of implementing combined therapy: simultaneously as initial therapy vs. stepped therapy, in which therapies are combined following initial behavioral or drug therapy alone. The third aim is to examine the costs and cost-effectiveness of combined behavioral + drug therapy compared to behavioral or drug therapy alone.


Condition Intervention Phase
Overactive Bladder
Lower Urinary Tract Symptoms
Behavioral: Behavioral training
Drug: Tolterodine + tamsulosin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Behavioral and Drug Treatment of Overactive Bladder in Men

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in frequency of urination [ Time Frame: After 6-week intervention period (phase 1) and 12-week crossover (phase 2) ] [ Designated as safety issue: No ]
    Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination


Secondary Outcome Measures:
  • Urgency [ Time Frame: After 6-week intervention and 12-week crossover ] [ Designated as safety issue: No ]
    Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale.

  • Urinary incontinence [ Time Frame: After 6-week intervention and 12-week crossover ] [ Designated as safety issue: No ]
    Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in freqeuncy of incontinence episodes.

  • Nocturia [ Time Frame: After 6-week intervention and 12-week crossover ] [ Designated as safety issue: No ]
    Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia.

  • Patient satisfaction [ Time Frame: After 6-week intervention and 12-week crossover ] [ Designated as safety issue: No ]
    Patient global ratings of satisfaction using the validated Patient Satisfaction Question

  • Patient perceptions of improvement [ Time Frame: After 6-week intervention and 12-week crossover ] [ Designated as safety issue: No ]
    Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement

  • Overactive Bladder Questionnaire (OAB-q) [ Time Frame: After 6-week intervention and 12-week crossover ] [ Designated as safety issue: No ]
    Change from baseline on the OAB-q to measure symptom bother and condition-specific health-related quality of life

  • International Prostate Symptom Score (IPSS) [ Time Frame: After 6-week intervention and 12-week crossover ] [ Designated as safety issue: No ]
    Change from baseline on the IPSS to measure urinary symptoms related to BPH


Estimated Enrollment: 201
Study Start Date: July 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Behavioral Treatment alone
Behavioral treatment is implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and daily bladder diaries, supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
Behavioral: Behavioral training
Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
Other Names:
  • Urge suppression
  • Delayed voiding
  • Pelvic floor muscle training
Active Comparator: Drug Therapy alone
Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Drug: Tolterodine + tamsulosin
Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily).
Other Names:
  • Flomax
  • Detrol LA
  • Tolterodine tartrate
Experimental: Combined Behavioral + Drug Therapy
Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
Behavioral: Behavioral training
Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
Other Names:
  • Urge suppression
  • Delayed voiding
  • Pelvic floor muscle training
Drug: Tolterodine + tamsulosin
Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily).
Other Names:
  • Flomax
  • Detrol LA
  • Tolterodine tartrate

Detailed Description:

Overactive bladder (OAB) is a very common, distressing condition that manifests as bothersome symptoms of urgency, frequent urination, urge incontinence, and nocturia, and impacts the lives of millions of men. OAB symptoms are most often treated with pharmacologic therapies (alpha-blocking agents and/or antimuscarinic agents) or behavioral treatments. Although drug therapies (even combined drug therapies) and behavioral treatments reduce OAB symptoms, few patients are completely cured with either treatment alone. Therefore, there is a need to improve interventions for this common problem. The primary purpose of this study is to test the effectiveness of combining behavioral treatment and drug therapy as a way to improve outcomes in the treatment of OAB symptoms in men. This is a 3-site, 2-stage, 3-arm randomized clinical trial of behavioral treatment, drug therapy, and combined drug + behavioral therapy for men with OAB, to examine the efficacy of combined therapy and whether it yields higher success rates than either therapy alone. 201 men with OAB will be enrolled and randomized to 1)drug therapy alone followed by combined therapy, 2)behavioral treatment alone followed by combined therapy, or 3)combined therapy as initial treatment.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Community-dwelling men
  2. Age 40 years or older
  3. Patient-reported urgency and 9.0 or more voids per 24-hour day (on average) on the 7-day baseline bladder diary.

Exclusion Criteria:

  1. Urinary flow rate < 8.0 mL/sec on a void greater than 125 ml.
  2. Post-void residual volume greater than 150 mL (based on bladder ultrasound after voiding in the presence of a normal urge to urinate).
  3. Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture). Patients will be referred for treatment with antibiotics and may be enrolled if OAB symptoms persist after the infection is resolved.
  4. Transurethral resection of the prostate (TURP), simple prostatectomy, or other BPH related surgery within the past 5 years.
  5. Current active treatment for prostate cancer.
  6. History of radical prostatectomy.
  7. Previous artificial urinary sphincter, sling procedure, bladder-injection of botulinum toxin, or implanted sacral neuromodulation device.
  8. Poorly controlled diabetes (glycosylated hemoglobin >9.0 within last 3 months). Subjects with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after the diabetes is controlled appropriately.
  9. Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on clearance by a urologist and agreement by the Site PI that entry into the treatment protocol is not contraindicated.
  10. Any unstable medical condition (particularly: cancers under active treatment, decompensated congestive heart failure, history of malignant arrhythmias, unstable angina, diagnosed by history or physical exam).
  11. Neurologic conditions such as Parkinson's, spinal cord injury, multiple sclerosis, or myasthenia gravis.
  12. Impaired mental status. Patients who screen as probable dementia on the Mini-Cog.
  13. Contraindications to the study drugs (tolterodine and tamsulosin) including history of postural hypotension with syncope, history of acute urinary retention requiring catheterization, narrow angle glaucoma, or history of gastric retention.
  14. Hypersensitivity to tolterodine or tamsulosin.
  15. Current use of an alpha blocker agent. Evaluation will be delayed until the drug has been discontinued for 2 weeks.
  16. Current use of an anti-muscarinic agent for OAB. Evaluation will be delayed until the drug has been discontinued for 2 weeks.
  17. If on a diuretic, dose has not been stable for at least 4 weeks.
  18. If taking dutasteride or finasteride, dose has not been stable for at least 6 months.
  19. If on an antibiotic for prostatitis. Patients will be offered re-evaluation if OAB symptoms persist when antibiotics are completed.
  20. Full course of behavioral training.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175382

Contacts
Contact: Susan Barnacastle (205) 933-8101 ext 7305 Susan.Barnacastle@va.gov

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Susan Barnacastle    205-933-8101 ext 7305    Susan.Barnacastle@va.gov   
Principal Investigator: Kathryn L Burgio, PhD         
Sub-Investigator: Patricia S Goode, MD         
Sub-Investigator: Alayne D Markland, DO         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30033
Contact: Sean Halpin, MA    404-321-6111 ext 5141    Sean.Halpin@va.gov   
Principal Investigator: Theodore M Johnson, 2nd, MD         
United States, Texas
University of Texas Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Caren Prather    210-567-0548    pratherc@uthscsa.edu   
Principal Investigator: Stephen R Kraus, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Kathryn L Burgio, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01175382     History of Changes
Other Study ID Numbers: 1R01DK082548-01A1
Study First Received: August 3, 2010
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Male Urogenital Diseases
Urinary Bladder, overactive
Behavioral Medicine
Drug Therapy

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Muscarinic Antagonists
Tamsulosin
Tolterodine
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 24, 2014