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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
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.
Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily).
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).
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
Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination.
Time frame: From Baseline to 6 Weeks
Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination.
Time frame: Change from 6 weeks to 12 weeks
Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination
Time frame: Baseline to 12 weeks
Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)
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 (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.
Time frame: From Baseline to 6 Weeks
Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)
Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes.
Time frame: From Baseline to 6 Weeks
Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)
Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia.
Time frame: From Baseline to 6 Weeks
Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)
Change from baseline on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.
Time frame: From Baseline to 6 Weeks
Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)
Change from baseline to 6 weeks on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to benign prostatic hypertrophy (BPH). The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Time frame: From Baseline to 6 Weeks
Patient Satisfaction
Patient global ratings of satisfaction using the validated Patient Satisfaction Question
Time frame: From Baseline to 6 Weeks
Patient Perceptions of Improvement
Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement
Time frame: From Baseline to 6 Weeks
How Bothersome Were Side Effects? 6 Week Report
Ordinal Rating regarding how bothersome side effects were
Time frame: From Baseline to 6 weeks
Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects 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 (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.
Time frame: Change from 6 weeks to 12 weeks
Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes.
Time frame: Change from 6 weeks to 12 weeks
Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia
Time frame: 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 weeks to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.
Time frame: Change from 6 week 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 on the International Prostate Symptom Score (IPSS) to measure urinary symptoms related to BPH.The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Time frame: Change from 6 weeks to 12 weeks
Patient Perception of Improvement at 12 Weeks
Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement.
Time frame: 12 weeks post randomization
Satisfaction With Progress at 12 Weeks
Patient global ratings of satisfaction using the validated Patient Satisfaction Question.
Time frame: 12 weeks post randomization
How Bothersome Were Side Effects? 12 Week Report
Ordinal Rating regarding how bothersome side effects were
Time frame: 12 weeks post randomization
Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in the frequency nocturia
Time frame: From Baseline to 12 weeks
Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urgency associated with each void and incontinent episode using the Indevus Urgency Severity Scale (IUSS). IUSS asks patients about the degree of urgency, as meant to describe the urge to urinate. Patients are asked to rate the degree of urgency and its impact on the completion of activity or tasks during the time that the urgency sensation is present and before reaching the toilet for a toilet void. Four distinct, subjective degrees of urgency severity were identified, including 1) no sensation of urgency, 2) awareness of urgency but easily tolerated, 3) urgency that is somewhat uncomfortable and 4) extreme urgency discomfort.
Time frame: From Baseline to 12 weeks
Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)
Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination
Time frame: From Baseline to 12 weeks
Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)
Change from baseline to 12 weeks on the OAB-q to measure symptom bother and condition-specific health-related quality of life. This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 weeks. Scale ranges from 8 to 48 with higher scores indicating a greater degree of bother.
Time frame: From Baseline to 12 weeks
Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)
Change from Baseline to 12 weeks on the International Prostate Symptom Score (I-PSS) to measure urinary symptoms related to BPH. The I-PSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Time frame: From Baseline to 12 weeks
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