Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)
This study is currently recruiting participants.
Verified December 2011 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00922506
First received: June 16, 2009
Last updated: December 9, 2011
Last verified: December 2011
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Purpose
OAB occurs in approximately 50% to 75% of men with BPO and up to 38% of men with BPO continue to suffer from OAB after relief the obstruction.Symptoms of OAB are more bothersome than the voiding complaints of slow stream and hesitancy. However, the patients with both BPO and OAB are often not treated with muscarinic receptor antagonists due to concern that they will experience acute urinary retention.
Tolterodine is a potent and pure muscarinic receptor antagonist that was developed specifically for the treatment of overactive bladder. Recently, studies revealed that tolterodine was effective, safe and well tolerated in adults with OAB and urodynamically confirmed BPO.However, the optimal dosage of antimuscarinic for the treatment of OAB coexisting BPO was not yet fully assessed. In real clinical situation, some patients complain voiding difficulty after addition of antimuscarinics and want to stop antimuscarinics.It is probable that a lower dosage of antimuscarinics combined with alpha-adrenergic antagonists can be used safely in OAB patients with BOO, with the same efficacy.
This study is designed to investigate the optimal doses of tolterodine SR in combination with doxazosin in men with both BOO and OAB based on efficacy, safety, and tolerability.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder Benign Prostatic Hyperplasia |
Drug: doxazosin plus tolterodine SR |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparison of the Efficacy and Safety of Combination Treatment With Doxazosin Plus TolterodineSR 2 mg vs Doxazosin Plus TolterodineSR 4 mg in Men With an OAB/BPO: Randomized Controlled Study" |
Resource links provided by NLM:
Further study details as provided by Samsung Medical Center:
Primary Outcome Measures:
- Numeric change of urgency episodes per 24 hours [ Time Frame: from baseline to 12 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in voiding diary parameters [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: Yes ]
- Change in symptom questionnaires [ Designated as safety issue: Yes ]
- Patient-Rated Global Assessments of Treatment Benefit, Satisfaction, and Willingness to Continue [ Designated as safety issue: Yes ]
- Change of uroflowmetry and PVR [ Designated as safety issue: Yes ]
- Incidence of acute urinary retention [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 260 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: doxazosin plus tolterodine SR 2 mg
doxazosin plus tolterodine SR(2 mg, qd) for 12 weeks
|
Drug: doxazosin plus tolterodine SR
doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks
Other Names:
|
|
Experimental: doxazosin plus tolterodine SR 4 mg
doxazosin plus tolterodine SR(4 mg,qd) for 12 weeks
|
Drug: doxazosin plus tolterodine SR
doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks
Other Names:
|
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male aged 50 ≤ and ≤ 80 years
- Proven bladder outlet obstruction (BOO, Abrams/Griffith score >20) on urodynamic study
Symptoms of OAB as verified by the 3 day voiding diary, defined by:
- symptoms of urinary urgency (defined as a level of ≥3 in a 5 point urgency scale) at least two episode per 24 hours and
- symptoms of urinary frequency (8 micturitions per 24 hours)
- Total International Prostate Symptom Score (IPSS) of 12 or higher
- IPSS quality-of-life (QOL) item score of 3 or higher
- A rating of the bladder condition at Baseline prior to randomization as "Some Moderate Problems", "Severe Problems", or "Many Severe Problems" on the Patient Perception of Bladder Condition (PPBC) questionnaire.
- Ability and willingness to correctly complete the micturition diary and questionnaire
- Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Exclusion Criteria:
- Patients have a baseline post-void residual (PVR) which exceeded 150 mL.
- Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention.
- Symptomatic acute urinary tract infection (UTI) during the screening period.
- Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder.
- A 5-alpha reductase inhibitor if started less than 3 months prior to screening.
- Patients with previous urethral, prostate or bladder neck surgery.
- Patients with cancer of any type including cancer of the prostate or bladder, uncontrolled medical condition including psychiatric disease or life threatening illness.
- Patients with Parkinson's disease, stroke, multiple sclerosis, spinal cord disease.
- Patients with suspected neurogenic bladder disorder.
- Patients with urethral stricture or bladder neck contracture.
- Serum PSA 4ng/ml (only patients with no malignancy by prostate biopsy can be included).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922506
Contacts
| Contact: Kyu-Sung Lee, Ph.D | 82-2-3410-3554 | ksleedr@skku.edu |
Locations
| Korea, Republic of | |
| Samsung Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-710 | |
| Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554 ksleedr@skku.edu | |
| Principal Investigator: Kyu-Sung Lee, Ph.D | |
Sponsors and Collaborators
Samsung Medical Center
Investigators
| Principal Investigator: | Kyu-Sung Lee, Ph.D | Samsung Medical Center |
More Information
No publications provided
| Responsible Party: | Kyu-Sung Lee/Professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00922506 History of Changes |
| Other Study ID Numbers: | 2008-08-092 |
| Study First Received: | June 16, 2009 |
| Last Updated: | December 9, 2011 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Keywords provided by Samsung Medical Center:
|
Overactive bladder Benign prostate hyperplasia Doxazosin Tolterodine |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Urinary Bladder, Overactive Prostatic Diseases Genital Diseases, Male Pathologic Processes Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Doxazosin Phenylpropanolamine Tolterodine Antihypertensive Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Adrenergic alpha-Agonists Adrenergic Agonists Appetite Depressants |
ClinicalTrials.gov processed this record on May 22, 2013