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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Treatment alone | Active Comparator | 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. |
|
| Drug Therapy (Tolterodine + tamsulosin) | Active Comparator | 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). |
|
| Combined Behavioral + Drug Therapy | Experimental | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn L Burgio, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811598 | Derived | Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2. | |
| 31930360 | Derived | Burgio KL, Kraus SR, Johnson TM 2nd, Markland AD, Vaughan CP, Li P, Redden DT, Goode PS. Effectiveness of Combined Behavioral and Drug Therapy for Overactive Bladder Symptoms in Men: A Randomized Clinical Trial. JAMA Intern Med. 2020 Mar 1;180(3):411-419. doi: 10.1001/jamainternmed.2019.6398. |
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Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form, or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis)
Protocol Open to Accrual: July 2010, Primary Completion Date: July 2015 and Study Completion Date: July 2015. Recruitment location: University of Alabama at Birmingham.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Treatment Alone | Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. 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, incremental 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. |
| FG001 | Drug Therapy Alone | 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 receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily). |
| FG002 | 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 skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and 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. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Treatment Alone | Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. 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, incremental 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | voids per day | From Baseline to 6 Weeks |
|
From Baseline through 12 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Treatment Alone | Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. 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, incremental 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Admittance to Hospital for Suicidal Thoughts | Psychiatric disorders | Non-systematic Assessment | Deemed unrelated to Behavioral Intervention |
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No limitations or caveats for this trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathryn Burgio | University of Alabama at Birmingham | 205-558-7064 | kburgio@uabmc.edu |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D059411 | Lower Urinary Tract Symptoms |
| D052801 | Male Urogenital Diseases |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| D000077409 | Tamsulosin |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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The design of this study is a 3 group randomized trial. Group 1 was randomized to drug only for the first 6 weeks, followed by a step up to drug plus behavior from 6 weeks to 12 weeks. Group 2 was randomized to behavior only for the first 6 weeks, followed by a step up to behavior plus drug from 6 weeks to 12 weeks. Group 3 was randomized to behavior plus drug from baseline to 12 weeks.
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| Tolterodine + tamsulosin | Drug | 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 + Drug Therapy | Other | 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). |
|
| 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. | 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. | 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. | 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). | From Baseline to 6 Weeks |
| Patient Satisfaction | Patient global ratings of satisfaction using the validated Patient Satisfaction Question | 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 | From Baseline to 6 Weeks |
| How Bothersome Were Side Effects? 6 Week Report | Ordinal Rating regarding how bothersome side effects were | 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. | 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. | 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 | 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. | 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). | 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. | 12 weeks post randomization |
| Satisfaction With Progress at 12 Weeks | Patient global ratings of satisfaction using the validated Patient Satisfaction Question. | 12 weeks post randomization |
| How Bothersome Were Side Effects? 12 Week Report | Ordinal Rating regarding how bothersome side effects were | 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 | 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. | 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 | 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. | 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). | From Baseline to 12 weeks |
| Atlanta |
| Georgia |
| 30033 |
| United States |
| University of Texas Health Science Center San Antonio | San Antonio | Texas | 78229 | United States |
| Withdrawal by Subject |
|
| No longer having problem |
|
| Unable/unwilling to attend visits |
|
| Unwilling to follow protocol |
|
| Unable to tolerate study meds |
|
| BG001 | Drug Therapy Alone | 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 receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily). |
| BG002 | 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 skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and 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. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Marital Status | Number | participants |
|
| Living Status | Number | participants |
|
| Earned Wages Outside Home | Number | participants |
|
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).
Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily).
| OG002 | 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). |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Voids per day | Change from 6 weeks to 12 weeks |
|
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|
|
| Primary | 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 | Posted | Mean | Standard Deviation | Voids per day | Baseline to 12 weeks |
|
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|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to 6 Weeks |
|
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|
| Secondary | 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. | Posted | Mean | Standard Deviation | episodes per week | From Baseline to 6 Weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | voids per night | From Baseline to 6 Weeks |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to 6 Weeks |
|
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|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | From Baseline to 6 Weeks |
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| Secondary | Patient Satisfaction | Patient global ratings of satisfaction using the validated Patient Satisfaction Question | Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis). | Posted | Count of Participants | Participants | From Baseline to 6 Weeks |
|
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| Secondary | Patient Perceptions of Improvement | Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement | Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis). | Posted | Count of Participants | Participants | From Baseline to 6 Weeks |
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| Secondary | How Bothersome Were Side Effects? 6 Week Report | Ordinal Rating regarding how bothersome side effects were | Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis). | Posted | Count of Participants | Participants | From Baseline to 6 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from 6 weeks to 12 weeks |
|
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|
| Secondary | 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. | Posted | Mean | Standard Deviation | Episodes per week | Change from 6 weeks to 12 weeks |
|
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|
| Secondary | 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 | Posted | Mean | Standard Deviation | Voids per night | Change from 6 weeks to 12 weeks |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Change from 6 week to 12 weeks |
|
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|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Change from 6 weeks to 12 weeks |
|
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| Secondary | Patient Perception of Improvement at 12 Weeks | Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement. | Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis). | Posted | Count of Participants | Participants | 12 weeks post randomization |
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| Secondary | Satisfaction With Progress at 12 Weeks | Patient global ratings of satisfaction using the validated Patient Satisfaction Question. | Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis). | Posted | Count of Participants | Participants | 12 weeks post randomization |
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| Secondary | How Bothersome Were Side Effects? 12 Week Report | Ordinal Rating regarding how bothersome side effects were | Sample sizes reported for analysis differs from the sample size in the Participant Flow Module for Outcomes in patient satisfaction, perception of improvement and bothersome side effects due to patients, either not completing the form or non-response to the questions, although they still enrolled in the study (applies for both 6 &12 week analysis). | Posted | Count of Participants | Participants | 12 weeks post randomization |
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| Secondary | 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 | Posted | Mean | Standard Deviation | voids per night | From Baseline to 12 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to 12 weeks |
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| Secondary | 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 | Posted | Mean | Standard Deviation | voids per day | From Baseline to 12 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to 12 weeks |
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| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | From Baseline to 12 weeks |
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| 0 |
| 71 |
| 1 |
| 71 |
| 0 |
| 71 |
| EG001 | Drug Therapy Alone | 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 receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily). | 0 | 68 | 2 | 68 | 0 | 68 |
| EG002 | 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 skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and 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. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily). | 0 | 65 | 1 | 65 | 0 | 65 |
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| Taking too much study medication | General disorders | Non-systematic Assessment | Subject within the Drug Only group misunderstood dosing regimen. No side effects observed, but reported to Internal Review Board (IRB) as Adverse Event |
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| Admitted to Hospital for Chest Pain | Cardiac disorders | Non-systematic Assessment | Subject within Drug Arm had a prior valve replacement 12 years prior to the study. Upon hospitalization, cardiology deemed a new valve was needed. It was deemed by the Data Safety Monitoring Board (DSMB), the Adverse Event was not related to study. |
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| Admission to Hospital for Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Patient within the Combined Arm was admitted to hospital for observation due to shortness of breath. Patient was discharged, expressed desire to continue in the study. DSMB concluded adverse event was not associated with study or study drug. |
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Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D013812 | Therapeutics |
| About the Same |
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| Worse |
|
| Somewhat Dissatisfied |
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| Very Dissatified |
|
| A little |
|
| Somewhat |
|
| Extremely |
|
| About the Same |
|
| Worse |
|
| Somewhat Dissatisfied |
|
| Very Dissatisfied |
|
| A little |
|
| Somewhat |
|
| Extremely |
|