Status:
COMPLETED
Combined Behavioral and Drug Treatment of Overactive Bladder in Men
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Overactive Bladder
Lower Urinary Tract Symptoms
Eligibility:
MALE
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
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...
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 million...
Eligibility Criteria
Inclusion
- Community-dwelling men
- Age 40 years or older
- Patient-reported urgency and 9.0 or more voids per 24-hour day (on average) on the 7-day baseline bladder diary.
Exclusion
- Urinary flow rate \< 8.0 mL/sec on a void greater than 125 ml.
- Post-void residual volume greater than 150 mL (based on bladder ultrasound after voiding in the presence of a normal urge to urinate).
- 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.
- Transurethral resection of the prostate (TURP), simple prostatectomy, or other benign prostatic hypertrophy (BPH) related surgery within the past 5 years.
- Current active treatment for prostate cancer.
- History of radical prostatectomy.
- Previous artificial urinary sphincter, sling procedure, bladder-injection of botulinum toxin, or implanted sacral neuromodulation device.
- 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.
- 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.
- 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).
- Neurologic conditions such as Parkinson's, spinal cord injury, multiple sclerosis, or myasthenia gravis.
- Impaired mental status. Patients who screen as probable dementia on the Mini-Cog.
- 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.
- Hypersensitivity to tolterodine or tamsulosin.
- Current use of an alpha blocker agent. Evaluation will be delayed until the drug has been discontinued for 2 weeks.
- Current use of an anti-muscarinic agent for OAB. Evaluation will be delayed until the drug has been discontinued for 2 weeks.
- If on a diuretic, dose has not been stable for at least 4 weeks.
- If taking dutasteride or finasteride, dose has not been stable for at least 6 months.
- If on an antibiotic for prostatitis. Patients will be offered re-evaluation if OAB symptoms persist when antibiotics are completed.
- Full course of behavioral training.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01175382
Start Date
July 1 2010
End Date
July 1 2015
Last Update
May 25 2017
Active Locations (3)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Emory University
Atlanta, Georgia, United States, 30033
3
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229