Combined Behavioral and Drug Treatment of Overactive Bladder in Men
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Overactive Bladder |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2010 |
| End Date: | July 2015 |
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.
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.
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.
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.
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.
We found this trial at
3
sites
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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