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Completed

NCT Number: NCT01175382

Combined Behavioral and Drug Treatment of Overactive Bladder in Men

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral training

Behavioral

Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.

Other names: Urge suppression, Delayed voiding, Pelvic floor muscle training

Tolterodine + tamsulosin

Drug

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

Other names: Flomax, Detrol Long-Acting (LA), Tolterodine tartrate

Combined Behavioral + Drug Therapy

Other

Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).

Primary outcomes

  1. 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.

  2. 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.

  3. 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

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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).

  6. Patient Satisfaction

    Time frame: From Baseline to 6 Weeks

    Patient global ratings of satisfaction using the validated Patient Satisfaction Question

  7. Patient Perceptions of Improvement

    Time frame: From Baseline to 6 Weeks

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

  8. How Bothersome Were Side Effects? 6 Week Report

    Time frame: From Baseline to 6 weeks

    Ordinal Rating regarding how bothersome side effects were

  9. Change in Urgency Score 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 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.

  10. Change in Urinary Incontinence 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 will be used to calculate changes in frequency of incontinence episodes.

  11. Change in Nocturia 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 will be used to calculate changes in frequency of nocturia

  12. 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 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.

  13. 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

    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).

  14. Patient Perception of Improvement at 12 Weeks

    Time frame: 12 weeks post randomization

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

  15. Satisfaction With Progress at 12 Weeks

    Time frame: 12 weeks post randomization

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

  16. How Bothersome Were Side Effects? 12 Week Report

    Time frame: 12 weeks post randomization

    Ordinal Rating regarding how bothersome side effects were

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Acronym: COBALT

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 4, 2010
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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