Overactive Bladder, Lower Urinary Tract Symptoms
Conditions
Keywords
Male Urogenital Diseases, Urinary Bladder, overactive, Behavioral Medicine, Drug Therapy
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.
Interventions
BEHAVIORALBehavioral training
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.
DRUGTolterodine + tamsulosin
Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily).
OTHERCombined 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).
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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 benign prostatic hypertrophy (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 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 After 6-week Intervention (Last Observation Carried Forward) | 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 Baseline to 12 Weeks (Last Observation Carried Forward) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward) | From Baseline to 6 Weeks | 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. |
| Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward) | From Baseline to 6 Weeks | 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). |
| Patient Satisfaction | From Baseline to 6 Weeks | Patient global ratings of satisfaction using the validated Patient Satisfaction Question |
| Patient Perceptions of Improvement | From Baseline to 6 Weeks | Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement |
| How Bothersome Were Side Effects? 6 Week Report | From Baseline to 6 weeks | Ordinal Rating regarding how bothersome side effects were |
| Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | Change from 6 weeks to 12 weeks | 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 in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | Change from 6 weeks to 12 weeks | 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 in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | Change from 6 weeks to 12 weeks | 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 in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward) | Change from 6 week to 12 weeks | 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 in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward) | From Baseline to 6 Weeks | 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. |
| Patient Perception of Improvement at 12 Weeks | 12 weeks post randomization | Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement. |
| Satisfaction With Progress at 12 Weeks | 12 weeks post randomization | Patient global ratings of satisfaction using the validated Patient Satisfaction Question. |
| How Bothersome Were Side Effects? 12 Week Report | 12 weeks post randomization | Ordinal Rating regarding how bothersome side effects were |
| Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward) | From Baseline to 12 weeks | Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in the frequency nocturia |
| Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward) | From Baseline to 12 weeks | 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. |
| Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward) | From Baseline to 12 weeks | Bladder diaries completed by subjects prior to randomization and following each phase of treatment will be used to calculate changes in frequency of urination |
| Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward) | From Baseline to 12 weeks | 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. |
| Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward) | From Baseline to 12 weeks | 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). |
| Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward) | Change from 6 weeks to 12 weeks | 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 in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward) | From Baseline to 6 Weeks | Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of incontinence episodes. |
| Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward) | From Baseline to 6 Weeks | Bladder diaries completed prior to randomization and following each phase of treatment will be used to calculate changes in frequency of nocturia. |
Countries
United States
Participant flow
Recruitment details
Protocol Open to Accrual: July 2010, Primary Completion Date: July 2015 and Study Completion Date: July 2015. Recruitment location: University of Alabama at Birmingham.
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| 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). | 68 |
| 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). | 65 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 | 1 |
| Overall Study | No longer having problem | 1 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Unable to tolerate study meds | 0 | 1 | 1 |
| Overall Study | Unable/unwilling to attend visits | 3 | 1 | 2 |
| Overall Study | Unwilling to follow protocol | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Drug Therapy Alone | Behavioral Treatment Alone | Combined Behavioral + Drug Therapy |
|---|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 11.1 | 65.5 years STANDARD_DEVIATION 11 | 63.6 years STANDARD_DEVIATION 10.9 | 63.2 years STANDARD_DEVIATION 11.6 |
| Earned Wages Outside Home No | 118 participants | 40 participants | 43 participants | 35 participants |
| Earned Wages Outside Home Yes | 86 participants | 28 participants | 28 participants | 30 participants |
| Living Status Alone | 46 participants | 19 participants | 14 participants | 13 participants |
| Living Status Other | 19 participants | 6 participants | 6 participants | 7 participants |
| Living Status With Someone | 139 participants | 43 participants | 51 participants | 45 participants |
| Marital Status Divorced | 38 participants | 15 participants | 16 participants | 7 participants |
| Marital Status Married | 115 participants | 34 participants | 40 participants | 41 participants |
| Marital Status Single | 44 participants | 15 participants | 13 participants | 16 participants |
| Marital Status Widowed | 7 participants | 4 participants | 2 participants | 1 participants |
| Race/Ethnicity, Customized Black | 54 participants | 20 participants | 14 participants | 20 participants |
| Race/Ethnicity, Customized Other | 17 participants | 4 participants | 9 participants | 4 participants |
| Race/Ethnicity, Customized White | 133 participants | 44 participants | 48 participants | 41 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 204 Participants | 68 Participants | 71 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 68 | 0 / 65 |
| other Total, other adverse events | 0 / 71 | 0 / 68 | 0 / 65 |
| serious Total, serious adverse events | 1 / 71 | 2 / 68 | 1 / 65 |
Outcome results
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.
Time frame: From Baseline to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) | 2.7 voids per day | Standard Deviation 2.4 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) | 1.5 voids per day | Standard Deviation 2.3 |
| Combined Behavioral + Drug Therapy | Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) | 3.3 voids per day | Standard Deviation 2.2 |
Comparison: Analysis of Covariance used to compare mean changes from baseline to 6 weeks among groups adjusting for baseline values and age. Last Observation Carried Forward was used for imputation of missing data.p-value: <0.0001ANOVA
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.
Time frame: Change from 6 weeks to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.7 Voids per day | Standard Deviation 1.2 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 1.4 Voids per day | Standard Deviation 1.9 |
| Combined Behavioral + Drug Therapy | Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.2 Voids per day | Standard Deviation 1 |
Comparison: Analysis of Covariance to test for differences in mean change from 6 weeks to 12 weeks in voiding frequency controlling for age and 6 week frequency. Last Observation Carried Forward was used to impute missing data.p-value: 0.0013ANCOVA
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
Time frame: Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) | 3.3 Voids per day | Standard Deviation 2.5 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) | 2.9 Voids per day | Standard Deviation 2.5 |
| Combined Behavioral + Drug Therapy | Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) | 3.5 Voids per day | Standard Deviation 2.3 |
Comparison: Analysis of Covariance testing whether mean change in 24-hour voiding frequency differed among the groups after adjusting for baseline voiding frequency and age. Last Observation Carried Forward was used to impute missing data.p-value: 0.2933ANCOVA
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).
Time frame: Change from 6 weeks to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward) | 2.7 units on a scale | Standard Deviation 4.4 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward) | 2.2 units on a scale | Standard Deviation 4 |
| Combined Behavioral + Drug Therapy | Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward) | 0.8 units on a scale | Standard Deviation 3 |
Comparison: Analysis of Covariance to test whether mean change in the International Prostate Symptom Scale (IPSS) from 6 to 12 weeks differed among groupsp-value: 0.2553ANCOVA
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).
Time frame: From Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward) | 6.7 units on a scale | Standard Deviation 5.5 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward) | 6.7 units on a scale | Standard Deviation 6.2 |
| Combined Behavioral + Drug Therapy | Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward) | 8.8 units on a scale | Standard Deviation 5.7 |
Comparison: Analysis of Covariance to test whether mean change in International Prostate Symptom Score from Baseline to 12 weeks differed among groups after controlling for baseline International Prostate Symptom Score and age. Last Observation Carried Forward was used to impute missing values.p-value: 0.2384ANCOVA
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).
Time frame: From Baseline to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward) | 4.0 units on a scale | Standard Deviation 3.9 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward) | 4.4 units on a scale | Standard Deviation 5.9 |
| Combined Behavioral + Drug Therapy | Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward) | 7.9 units on a scale | Standard Deviation 5.2 |
Comparison: Analysis of Covariance comparing mean chance in IPSS from baseline to 6 weeks among groups controlling for baseline IPSS values and age.~Last Observation Carried Forward was used to impute missing data.p-value: <0.0001ANCOVA
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
Time frame: Change from 6 weeks to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.1 Voids per night | Standard Deviation 0.6 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.3 Voids per night | Standard Deviation 0.9 |
| Combined Behavioral + Drug Therapy | Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.1 Voids per night | Standard Deviation 0.6 |
Comparison: Analysis of Covariance used to test whether mean changes in nocturia from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week nocturia frequency. Last Observation Carried Forward was used to impute missing values.p-value: 0.5578ANCOVA
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.
Time frame: From Baseline to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward) | 0.7 voids per night | Standard Deviation 1 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward) | 0.4 voids per night | Standard Deviation 0.9 |
| Combined Behavioral + Drug Therapy | Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward) | 0.8 voids per night | Standard Deviation 1.1 |
Comparison: Analysis of Covariance comparing mean change in Nocturia among groups adjusting for baseline values of nocturia and age. Last Observation Carried Forward was used to impute missing data.p-value: 0.0015ANCOVA
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
Time frame: From Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward) | 0.8 voids per night | Standard Deviation 1 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward) | 0.7 voids per night | Standard Deviation 1 |
| Combined Behavioral + Drug Therapy | Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward) | 0.9 voids per night | Standard Deviation 1 |
Comparison: Analysis of Covariance testing whether mean change in Nocturia frequency differed among the groups after adjusting for baseline Nocturia frequency and age. Last Observation Carried Forward was used to impute missing datap-value: 0.2035ANCOVA
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.
Time frame: Change from 6 week to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward) | 17.3 units on a scale | Standard Deviation 20.9 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward) | 10.8 units on a scale | Standard Deviation 17.9 |
| Combined Behavioral + Drug Therapy | Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward) | 4.6 units on a scale | Standard Deviation 13.9 |
Comparison: Analysis of Covariance to test whether mean change in Overactive Bladder Questionnaire (OAB-q) from 6 to 12 weeks differed among groups after controlling for age and 6 week OAB-q score. Last Observation Carried Forward was used to impute missing values.p-value: 0.0279ANCOVA
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.
Time frame: From Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward) | 37.3 units on a scale | Standard Deviation 31.8 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward) | 31.0 units on a scale | Standard Deviation 29.8 |
| Combined Behavioral + Drug Therapy | Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward) | 42.1 units on a scale | Standard Deviation 34.1 |
Comparison: Analysis of Covariance testing whether mean change in Overactive Bladder Questionnaire differed among the groups after adjusting for baseline Overactive Bladder Questionnaire Score and age. Last Observation Carried Forward was used to impute missing datap-value: 0.0529ANCOVA
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.
Time frame: From Baseline to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward) | 19.9 units on a scale | Standard Deviation 20.8 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward) | 20.2 units on a scale | Standard Deviation 27.5 |
| Combined Behavioral + Drug Therapy | Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward) | 37.5 units on a scale | Standard Deviation 31.8 |
Comparison: Analysis of Covariance comparing mean change in Overactive Bladder Questionnaire from baseline to 6 weeks among groups after controlling for baseline value and age. Last Observation Carried Forward was used to impute missing data.p-value: <0.0001ANCOVA
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.
Time frame: From Baseline to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward) | -0.1 units on a scale | Standard Deviation 0.5 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward) | 0.1 units on a scale | Standard Deviation 0.5 |
| Combined Behavioral + Drug Therapy | Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward) | 0.2 units on a scale | Standard Deviation 0.6 |
Comparison: Analysis of Covariance used to test means changes among the groups adjusting for baseline values and age. Last Observation Carried Forward was used to impute missing data.p-value: 0.0051ANCOVA
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.
Time frame: Change from 6 weeks to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.1 units on a scale | Standard Deviation 0.4 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.1 units on a scale | Standard Deviation 0.4 |
| Combined Behavioral + Drug Therapy | Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.1 units on a scale | Standard Deviation 0.4 |
Comparison: Analysis of Covariance used to test whether mean changes in Urgency Score from 6 weeks to 12 weeks differed among groups after controlling for age and 6 week Urgency Score. Last Observation Carried Forward was used to impute missing values.p-value: 0.669ANCOVA
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.
Time frame: From Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward) | 0.0 units on a scale | Standard Deviation 0.5 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward) | 0.1 units on a scale | Standard Deviation 0.6 |
| Combined Behavioral + Drug Therapy | Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward) | 0.2 units on a scale | Standard Deviation 0.6 |
Comparison: Analysis of Covariance testing whether mean change in Urgency Score differed among the groups after adjusting for Urgency Scoe and age. Last Observation Carried Forward was used to impute missing datap-value: 0.0549ANCOVA
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
Time frame: From Baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward) | 4.6 voids per day | Standard Deviation 8.5 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward) | 4.6 voids per day | Standard Deviation 10.1 |
| Combined Behavioral + Drug Therapy | Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward) | 5.2 voids per day | Standard Deviation 8.4 |
Comparison: Analysis of Covariance testing whether mean change in Incontinent Episodes differed among the groups after adjusting for baseline Incontinent episodes frequency and age. Last Observation Carried Forward was used to impute missing datap-value: 0.507ANCOVA
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.
Time frame: Change from 6 weeks to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 1.3 Episodes per week | Standard Deviation 3.6 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 1.5 Episodes per week | Standard Deviation 4.5 |
| Combined Behavioral + Drug Therapy | Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward) | 0.0 Episodes per week | Standard Deviation 2.7 |
Comparison: Analysis of Covariance to test whether mean change in Incontinence Episodes from 6 weeks to 12 weeks differed among groups after controlling for age and frequency of incontinence episodes at 6 weeks. Last Observation Carried Forward was used to impute missing values.p-value: 0.0812ANCOVA
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.
Time frame: From Baseline to 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Treatment Alone | Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward) | 3.4 episodes per week | Standard Deviation 7 |
| Drug Therapy (Tolterodine + Tamsulosin) | Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward) | 3.1 episodes per week | Standard Deviation 10.6 |
| Combined Behavioral + Drug Therapy | Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward) | 5.2 episodes per week | Standard Deviation 8.7 |
Comparison: Analysis of Covariance comparing mean change score among groups controlling for age and baseline scorep-value: 0.1402ANCOVA
Secondary
How Bothersome Were Side Effects? 12 Week Report
Ordinal Rating regarding how bothersome side effects were
Time frame: 12 weeks post randomization
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 12 Week Report | Not at all bothersome | 17 Participants |
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 12 Week Report | Somewhat | 14 Participants |
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 12 Week Report | No Side Effect | 13 Participants |
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 12 Week Report | A little | 16 Participants |
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 12 Week Report | Extremely | 2 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 12 Week Report | A little | 27 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 12 Week Report | Somewhat | 12 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 12 Week Report | Extremely | 1 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 12 Week Report | Not at all bothersome | 12 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 12 Week Report | No Side Effect | 9 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 12 Week Report | Extremely | 2 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 12 Week Report | No Side Effect | 12 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 12 Week Report | Not at all bothersome | 10 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 12 Week Report | A little | 16 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 12 Week Report | Somewhat | 19 Participants |
p-value: 0.5536Cochran-Mantel-Haenszel
Secondary
How Bothersome Were Side Effects? 6 Week Report
Ordinal Rating regarding how bothersome side effects were
Time frame: From Baseline to 6 weeks
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 6 Week Report | Somewhat | 3 Participants |
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 6 Week Report | A little | 6 Participants |
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 6 Week Report | No Side effects | 33 Participants |
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 6 Week Report | Not at all bothersome | 22 Participants |
| Behavioral Treatment Alone | How Bothersome Were Side Effects? 6 Week Report | Extremely | 0 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 6 Week Report | A little | 20 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 6 Week Report | No Side effects | 12 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 6 Week Report | Not at all bothersome | 9 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 6 Week Report | Somewhat | 18 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | How Bothersome Were Side Effects? 6 Week Report | Extremely | 6 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 6 Week Report | Extremely | 1 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 6 Week Report | Somewhat | 10 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 6 Week Report | No Side effects | 8 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 6 Week Report | A little | 29 Participants |
| Combined Behavioral + Drug Therapy | How Bothersome Were Side Effects? 6 Week Report | Not at all bothersome | 13 Participants |
p-value: 0.0217Cochran-Mantel-Haenszel
Secondary
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
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Treatment Alone | Patient Perception of Improvement at 12 Weeks | Much Better | 28 Participants |
| Behavioral Treatment Alone | Patient Perception of Improvement at 12 Weeks | Better | 27 Participants |
| Behavioral Treatment Alone | Patient Perception of Improvement at 12 Weeks | About the Same | 5 Participants |
| Behavioral Treatment Alone | Patient Perception of Improvement at 12 Weeks | Worse | 2 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Perception of Improvement at 12 Weeks | Worse | 0 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Perception of Improvement at 12 Weeks | Much Better | 26 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Perception of Improvement at 12 Weeks | About the Same | 9 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Perception of Improvement at 12 Weeks | Better | 26 Participants |
| Combined Behavioral + Drug Therapy | Patient Perception of Improvement at 12 Weeks | Worse | 0 Participants |
| Combined Behavioral + Drug Therapy | Patient Perception of Improvement at 12 Weeks | Better | 26 Participants |
| Combined Behavioral + Drug Therapy | Patient Perception of Improvement at 12 Weeks | About the Same | 3 Participants |
| Combined Behavioral + Drug Therapy | Patient Perception of Improvement at 12 Weeks | Much Better | 30 Participants |
p-value: 0.3165Cochran-Mantel-Haenszel
Secondary
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
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Treatment Alone | Patient Perceptions of Improvement | Completely | 18 Participants |
| Behavioral Treatment Alone | Patient Perceptions of Improvement | Somewhat Satisfied | 42 Participants |
| Behavioral Treatment Alone | Patient Perceptions of Improvement | Somewhat Dissatisfied | 3 Participants |
| Behavioral Treatment Alone | Patient Perceptions of Improvement | Very Dissatified | 1 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Perceptions of Improvement | Very Dissatified | 3 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Perceptions of Improvement | Completely | 13 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Perceptions of Improvement | Somewhat Dissatisfied | 8 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Perceptions of Improvement | Somewhat Satisfied | 41 Participants |
| Combined Behavioral + Drug Therapy | Patient Perceptions of Improvement | Very Dissatified | 0 Participants |
| Combined Behavioral + Drug Therapy | Patient Perceptions of Improvement | Somewhat Satisfied | 30 Participants |
| Combined Behavioral + Drug Therapy | Patient Perceptions of Improvement | Somewhat Dissatisfied | 1 Participants |
| Combined Behavioral + Drug Therapy | Patient Perceptions of Improvement | Completely | 30 Participants |
p-value: 0.0222Cochran-Mantel-Haenszel
Secondary
Patient Satisfaction
Patient global ratings of satisfaction using the validated Patient Satisfaction Question
Time frame: From Baseline to 6 Weeks
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Treatment Alone | Patient Satisfaction | Much Better | 13 Participants |
| Behavioral Treatment Alone | Patient Satisfaction | Better | 39 Participants |
| Behavioral Treatment Alone | Patient Satisfaction | About the Same | 12 Participants |
| Behavioral Treatment Alone | Patient Satisfaction | Worse | 0 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Satisfaction | Worse | 1 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Satisfaction | Much Better | 9 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Satisfaction | About the Same | 22 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Patient Satisfaction | Better | 33 Participants |
| Combined Behavioral + Drug Therapy | Patient Satisfaction | Worse | 0 Participants |
| Combined Behavioral + Drug Therapy | Patient Satisfaction | Better | 31 Participants |
| Combined Behavioral + Drug Therapy | Patient Satisfaction | About the Same | 6 Participants |
| Combined Behavioral + Drug Therapy | Patient Satisfaction | Much Better | 24 Participants |
p-value: 0.0022Cochran-Mantel-Haenszel
Secondary
Satisfaction With Progress at 12 Weeks
Patient global ratings of satisfaction using the validated Patient Satisfaction Question.
Time frame: 12 weeks post randomization
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Treatment Alone | Satisfaction With Progress at 12 Weeks | Completely | 32 Participants |
| Behavioral Treatment Alone | Satisfaction With Progress at 12 Weeks | Somewhat Satisfied | 26 Participants |
| Behavioral Treatment Alone | Satisfaction With Progress at 12 Weeks | Somewhat Dissatisfied | 3 Participants |
| Behavioral Treatment Alone | Satisfaction With Progress at 12 Weeks | Very Dissatisfied | 1 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Satisfaction With Progress at 12 Weeks | Very Dissatisfied | 1 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Satisfaction With Progress at 12 Weeks | Completely | 32 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Satisfaction With Progress at 12 Weeks | Somewhat Dissatisfied | 0 Participants |
| Drug Therapy (Tolterodine + Tamsulosin) | Satisfaction With Progress at 12 Weeks | Somewhat Satisfied | 28 Participants |
| Combined Behavioral + Drug Therapy | Satisfaction With Progress at 12 Weeks | Very Dissatisfied | 1 Participants |
| Combined Behavioral + Drug Therapy | Satisfaction With Progress at 12 Weeks | Somewhat Satisfied | 29 Participants |
| Combined Behavioral + Drug Therapy | Satisfaction With Progress at 12 Weeks | Somewhat Dissatisfied | 1 Participants |
| Combined Behavioral + Drug Therapy | Satisfaction With Progress at 12 Weeks | Completely | 28 Participants |
p-value: 0.8153Cochran-Mantel-Haenszel