Combined Behavioral and Drug Treatment of Overactive Bladder in Men
Overview
- Phase
- Phase 2
- Intervention
- Behavioral training
- Conditions
- Overactive Bladder
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 204
- Locations
- 3
- Primary Endpoint
- Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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.
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. 204 men with OAB were 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.
Investigators
Kathryn Burgio
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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).
Arms & Interventions
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.
Intervention: Behavioral training
Drug Therapy (Tolterodine + tamsulosin)
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).
Intervention: Tolterodine + tamsulosin
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).
Intervention: Combined Behavioral + Drug Therapy
Outcomes
Primary Outcomes
Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)
Time Frame: From Baseline to 6 Weeks
Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination.
Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Time Frame: Change from 6 weeks to 12 weeks
Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination.
Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)
Time Frame: Baseline to 12 weeks
Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination
Secondary Outcomes
- Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)(From Baseline to 6 Weeks)
- Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)(From Baseline to 6 Weeks)
- Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)(From Baseline to 6 Weeks)
- Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)(From Baseline to 6 Weeks)
- Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)(From Baseline to 6 Weeks)
- Patient Satisfaction(From Baseline to 6 Weeks)
- Patient Perceptions of Improvement(From Baseline to 6 Weeks)
- How Bothersome Were Side Effects? 6 Week Report(From Baseline to 6 weeks)
- Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)(Change from 6 weeks to 12 weeks)
- Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)(Change from 6 weeks to 12 weeks)
- Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)(Change from 6 weeks to 12 weeks)
- Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)(Change from 6 week to 12 weeks)
- Satisfaction With Progress at 12 Weeks(12 weeks post randomization)
- How Bothersome Were Side Effects? 12 Week Report(12 weeks post randomization)
- Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)(From Baseline to 12 weeks)
- Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)(Change from 6 weeks to 12 weeks)
- Patient Perception of Improvement at 12 Weeks(12 weeks post randomization)
- Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)(From Baseline to 12 weeks)
- Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)(From Baseline to 12 weeks)
- Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)(From Baseline to 12 weeks)
- Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)(From Baseline to 12 weeks)