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Combined Behavioral and Drug Treatment of Overactive Bladder in Men (COBALT)

Primary Purpose

Overactive Bladder, Lower Urinary Tract Symptoms

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Behavioral training

Tolterodine + tamsulosin

Combined Behavioral + Drug Therapy

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Male Urogenital Diseases, Urinary Bladder, overactive, Behavioral Medicine, Drug Therapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Community-dwelling men
Age 40 years or older
Patient-reported urgency and 9.0 or more voids per 24-hour day (on average) on the 7-day baseline bladder diary.

Exclusion Criteria:

Urinary flow rate < 8.0 mL/sec on a void greater than 125 ml.
Post-void residual volume greater than 150 mL (based on bladder ultrasound after voiding in the presence of a normal urge to urinate).
Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture). Patients will be referred for treatment with antibiotics and may be enrolled if OAB symptoms persist after the infection is resolved.
Transurethral resection of the prostate (TURP), simple prostatectomy, or other benign prostatic hypertrophy (BPH) related surgery within the past 5 years.
Current active treatment for prostate cancer.
History of radical prostatectomy.
Previous artificial urinary sphincter, sling procedure, bladder-injection of botulinum toxin, or implanted sacral neuromodulation device.
Poorly controlled diabetes (glycosylated hemoglobin >9.0 within last 3 months). Subjects with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after the diabetes is controlled appropriately.
Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on clearance by a urologist and agreement by the Site PI that entry into the treatment protocol is not contraindicated.
Any unstable medical condition (particularly: cancers under active treatment, decompensated congestive heart failure, history of malignant arrhythmias, unstable angina, diagnosed by history or physical exam).
Neurologic conditions such as Parkinson's, spinal cord injury, multiple sclerosis, or myasthenia gravis.
Impaired mental status. Patients who screen as probable dementia on the Mini-Cog.
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.
Hypersensitivity to tolterodine or tamsulosin.
Current use of an alpha blocker agent. Evaluation will be delayed until the drug has been discontinued for 2 weeks.
Current use of an anti-muscarinic agent for OAB. Evaluation will be delayed until the drug has been discontinued for 2 weeks.
If on a diuretic, dose has not been stable for at least 4 weeks.
If taking dutasteride or finasteride, dose has not been stable for at least 6 months.
If on an antibiotic for prostatitis. Patients will be offered re-evaluation if OAB symptoms persist when antibiotics are completed.
Full course of behavioral training.

Sites / Locations

University of Alabama at Birmingham
Emory University
University of Texas Health Science Center San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Behavioral Treatment alone

Drug Therapy (Tolterodine + tamsulosin)

Combined Behavioral + Drug Therapy

Arm Description

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 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 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).

Outcomes

Primary Outcome Measures

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.

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 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

Secondary Outcome Measures

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.

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.

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.

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.

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).

Patient Satisfaction

Patient global ratings of satisfaction using the validated Patient Satisfaction Question

Patient Perceptions of Improvement

Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement

How Bothersome Were Side Effects? 6 Week Report

Ordinal Rating regarding how bothersome side effects were

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 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 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 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 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).

Patient Perception of Improvement at 12 Weeks

Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement.

Satisfaction With Progress at 12 Weeks

Patient global ratings of satisfaction using the validated Patient Satisfaction Question.

How Bothersome Were Side Effects? 12 Week Report

Ordinal Rating regarding how bothersome side effects were

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

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.

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

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.

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).

Full Information

NCT ID

NCT01175382

First Posted

August 3, 2010

Last Updated

April 17, 2017

Sponsor

University of Alabama at Birmingham

1. Study Identification

Unique Protocol Identification Number

NCT01175382

Brief Title

Combined Behavioral and Drug Treatment of Overactive Bladder in Men

Acronym

COBALT

Official Title

Combined Behavioral and Drug Treatment of Overactive Bladder in Men

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder, Lower Urinary Tract Symptoms

Keywords

Male Urogenital Diseases, Urinary Bladder, overactive, Behavioral Medicine, Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Behavioral Treatment alone

Arm Type

Active Comparator

Arm Description

Arm Title

Drug Therapy (Tolterodine + tamsulosin)

Arm Type

Active Comparator

Arm Description

Arm Title

Combined Behavioral + Drug Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral training

Other Intervention Name(s)

Urge suppression, Delayed voiding, Pelvic floor muscle training

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Tolterodine + tamsulosin

Other Intervention Name(s)

Flomax, Detrol Long-Acting (LA), Tolterodine tartrate

Intervention Description

Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily).

Intervention Type

Other

Intervention Name(s)

Combined Behavioral + Drug Therapy

Intervention Description

Primary Outcome Measure Information:

Title

Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)

Description

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

Title

Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Description

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

Title

Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)

Description

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

Secondary Outcome Measure Information:

Title

Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)

Description

Time Frame

From Baseline to 6 Weeks

Title

Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)

Description

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

Title

Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)

Description

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

Title

Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)

Description

Time Frame

From Baseline to 6 Weeks

Title

Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)

Description

Time Frame

From Baseline to 6 Weeks

Title

Patient Satisfaction

Description

Patient global ratings of satisfaction using the validated Patient Satisfaction Question

Time Frame

From Baseline to 6 Weeks

Title

Patient Perceptions of Improvement

Description

Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement

Time Frame

From Baseline to 6 Weeks

Title

How Bothersome Were Side Effects? 6 Week Report

Description

Ordinal Rating regarding how bothersome side effects were

Time Frame

From Baseline to 6 weeks

Title

Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Description

Time Frame

Change from 6 weeks to 12 weeks

Title

Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Description

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

Title

Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)

Description

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

Title

Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)

Description

Time Frame

Change from 6 week to 12 weeks

Title

Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)

Description

Time Frame

Change from 6 weeks to 12 weeks

Title

Patient Perception of Improvement at 12 Weeks

Description

Patient global ratings of improvement using the validated Estimated Percent Improvement and Global Perception of Improvement.

Time Frame

12 weeks post randomization

Title

Satisfaction With Progress at 12 Weeks

Description

Patient global ratings of satisfaction using the validated Patient Satisfaction Question.

Time Frame

12 weeks post randomization

Title

How Bothersome Were Side Effects? 12 Week Report

Description

Ordinal Rating regarding how bothersome side effects were

Time Frame

12 weeks post randomization

Title

Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)

Description

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

Title

Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)

Description

Time Frame

From Baseline to 12 weeks

Title

Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)

Description

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

Title

Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)

Description

Time Frame

From Baseline to 12 weeks

Title

Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)

Description

Time Frame

From Baseline to 12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Community-dwelling men Age 40 years or older Patient-reported urgency and 9.0 or more voids per 24-hour day (on average) on the 7-day baseline bladder diary. Exclusion Criteria: Urinary flow rate < 8.0 mL/sec on a void greater than 125 ml. Post-void residual volume greater than 150 mL (based on bladder ultrasound after voiding in the presence of a normal urge to urinate). Urinary tract infection (defined as growth of greater than 10,000 colonies per ml of a urinary pathogen on urine culture). Patients will be referred for treatment with antibiotics and may be enrolled if OAB symptoms persist after the infection is resolved. Transurethral resection of the prostate (TURP), simple prostatectomy, or other benign prostatic hypertrophy (BPH) related surgery within the past 5 years. Current active treatment for prostate cancer. History of radical prostatectomy. Previous artificial urinary sphincter, sling procedure, bladder-injection of botulinum toxin, or implanted sacral neuromodulation device. Poorly controlled diabetes (glycosylated hemoglobin >9.0 within last 3 months). Subjects with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after the diabetes is controlled appropriately. Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended and enrollment will depend on clearance by a urologist and agreement by the Site PI that entry into the treatment protocol is not contraindicated. Any unstable medical condition (particularly: cancers under active treatment, decompensated congestive heart failure, history of malignant arrhythmias, unstable angina, diagnosed by history or physical exam). Neurologic conditions such as Parkinson's, spinal cord injury, multiple sclerosis, or myasthenia gravis. Impaired mental status. Patients who screen as probable dementia on the Mini-Cog. 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. Hypersensitivity to tolterodine or tamsulosin. Current use of an alpha blocker agent. Evaluation will be delayed until the drug has been discontinued for 2 weeks. Current use of an anti-muscarinic agent for OAB. Evaluation will be delayed until the drug has been discontinued for 2 weeks. If on a diuretic, dose has not been stable for at least 4 weeks. If taking dutasteride or finasteride, dose has not been stable for at least 6 months. If on an antibiotic for prostatitis. Patients will be offered re-evaluation if OAB symptoms persist when antibiotics are completed. Full course of behavioral training.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathryn L Burgio, PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

University of Texas Health Science Center San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31930360

Citation

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.

Results Reference

derived

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Combined Behavioral and Drug Treatment of Overactive Bladder in Men

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