Overactive BladderPhase 2/3COBALTNCT01175382
Combined Behavioral and Drug Treatment of Overactive Bladder in Men
A Phase 2/3 study testing Behavioral training, Tolterodine + tamsulosin and Combined Behavioral + Drug Therapy in people with Overactive Bladder and Lower Urinary Tract Symptoms, run by University of Alabama at Birmingham at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Overactive Bladder, Lower Urinary Tract Symptoms
- What is being tested?
- Behavioral training, Tolterodine + tamsulosin and Combined Behavioral + Drug Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2010to Jul 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30033
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
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.
Read the 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.
- Conditions
- Overactive Bladder, Lower Urinary Tract Symptoms
- Being tested
- Behavioral training, Tolterodine + tamsulosin, Combined Behavioral + Drug Therapy
- Keywords
- Male Urogenital Diseases, Urinary Bladder, overactive, Behavioral Medicine, Drug Therapy
- Medical subject headings
- Urinary Bladder, Overactive, Lower Urinary Tract Symptoms, Male Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral trainingBehavioural
Also called Urge suppression, Delayed voiding, Pelvic floor muscle 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.
Tolterodine + tamsulosinDrug
Also called Flomax, Detrol Long-Acting (LA), Tolterodine tartrate
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 TherapyOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral training |
| 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). Receives: Drug: Tolterodine + tamsulosin |
| 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). Receives: Other: Combined Behavioral + Drug Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline to 12 weeks
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From Baseline to 6 Weeks
Patient Satisfaction
Patient global ratings of satisfaction using the validated Patient Satisfaction Question
Measured: 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
Measured: From Baseline to 6 Weeks
How Bothersome Were Side Effects? 6 Week Report
Ordinal Rating regarding how bothersome side effects were
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 12 weeks post randomization
Satisfaction With Progress at 12 Weeks
Patient global ratings of satisfaction using the validated Patient Satisfaction Question.
Measured: 12 weeks post randomization
How Bothersome Were Side Effects? 12 Week Report
Ordinal Rating regarding how bothersome side effects were
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: From Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Burgio, University of Alabama at Birmingham
- Investigators
- Kathryn L Burgio, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175382
- Sponsor's protocol ID
- 1R01DK082548-01A1
- Acronym
- COBALT
- Status last verified
- Apr 2017
- First submitted
- 3 Aug 2010
- Last updated
- 25 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37811598Burgio 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.
PubMed 31930360
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Behavioral and Drug Treatment of Overactive Bladder in Men
- ClinicalTrials.gov ID
- NCT01175382
- Acronym / sponsor ID
- COBALT / 1R01DK082548-01A1
- Conditions
- Overactive Bladder, Lower Urinary Tract Symptoms
- Keywords
- Male Urogenital Diseases, Urinary Bladder, overactive, Behavioral Medicine, Drug Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Posted 25 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Treatment alone | Active comparator | Behavioral: Behavioral trainingBehavioral 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: Tolterodine + tamsulosinDrug 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 | Other: Combined Behavioral + Drug TherapyCombined 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral trainingAlso: Urge suppression, Delayed voiding, Pelvic floor muscle trainingBehavioral 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. | Behavioural | Behavioral Treatment alone |
| Tolterodine + tamsulosinAlso: Flomax, Detrol Long-Acting (LA), Tolterodine tartratePatients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily). | Drug | Drug Therapy (Tolterodine + tamsulosin) |
| Combined Behavioral + Drug TherapyCombined 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). | Other | Combined Behavioral + Drug Therapy |
Primary outcome
Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward)
Time frame: From Baseline to 6 Weeks
Bladder diaries completed by subjects prior to randomization and following the first phase of treatment was used to calculate changes in frequency of urination.
Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Time frame: Change from 6 weeks to 12 weeks
Bladder diaries completed by subjects prior to randomization and following each phase of treatment were used to calculate changes in frequency of urination.
Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward)
Time frame: Baseline to 12 weeks
Bladder diaries completed by subjects prior to randomization and following the second phase of treatment were used to calculate changes in frequency of urination
21 secondary outcomes
Change in Urgency From Baseline to 6 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 6 Weeks
Change in Urinary Incontinence From Baseline to 6 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 6 Weeks
Change in Nocturia From Baseline to 6 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 6 Weeks
Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 6 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 6 Weeks
Change in International Prostate Symptom Score (I-PSS) From Baseline to 6 Weeks. (Last Observation Carried Forward)
Time frame: From Baseline to 6 Weeks
Patient Satisfaction
Time frame: From Baseline to 6 Weeks
Patient Perceptions of Improvement
Time frame: From Baseline to 6 Weeks
How Bothersome Were Side Effects? 6 Week Report
Time frame: From Baseline to 6 weeks
Change in Urgency Score From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Time frame: Change from 6 weeks to 12 weeks
Change in Urinary Incontinence From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Time frame: Change from 6 weeks to 12 weeks
Change in Nocturia From 6 Weeks to 12 Weeks (Last Observation Carried Forward)
Time frame: Change from 6 weeks to 12 weeks
Change in Overactive Bladder Questionnaire (OAB-q) From 6 to 12 Weeks (Last Observation Carried Forward)
Time frame: Change from 6 week to 12 weeks
Change in International Prostate Symptom Score (IPSS) From 6 to 12 Weeks (Last Observation Carried Forward)
Time frame: Change from 6 weeks to 12 weeks
Patient Perception of Improvement at 12 Weeks
Time frame: 12 weeks post randomization
Satisfaction With Progress at 12 Weeks
Time frame: 12 weeks post randomization
How Bothersome Were Side Effects? 12 Week Report
Time frame: 12 weeks post randomization
Change in Nocturia Measured From Baseline to 12 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 12 weeks
Change in Urgency Score From Baseline to 12 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 12 weeks
Change in Urinary Incontinence Episodes From Baseline to 12 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 12 weeks
Change in Overactive Bladder Questionnaire (OAB-q) From Baseline to 12 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 12 weeks
Change in International Prostate Symptom Score (I-PSS) From Baseline to 12 Weeks (Last Observation Carried Forward)
Time frame: From Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37811598Funada 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.
- Derived from this study: PubMed 31930360Burgio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn L Burgio, PhD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Behavioral training, Tolterodine + tamsulosin and Combined Behavioral + Drug Therapy in people with Overactive Bladder and Lower Urinary Tract Symptoms, run by University of Alabama at Birmingham at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) (time frame: From Baseline to 6 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01175382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.