Combined Behavioral and Drug Treatment of Overactive Bladder in Men

Completed · Phase 2/Phase 3

Conditions studied: Overactive Bladder, Lower Urinary Tract Symptoms

In brief

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.

Key facts

Study ID

NCT01175382

Run by

University of Alabama at Birmingham

People needed

204

Starts

2010-07-01

Expected to finish

2015-07-01

Last updated by the study team

2017-05-25

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Emory University — Atlanta, Georgia, United States
• University of Texas Health Science Center San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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