Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00922506 |
|
Recruitment Status : Unknown
Verified January 2014 by KYU-SUNG LEE, Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : June 17, 2009
Last Update Posted : February 16, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Overactive Bladder Benign Prostatic Hyperplasia | Drug: doxazosin plus tolterodine SR | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 260 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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" |
| Study Start Date : | May 2009 |
| Estimated Primary Completion Date : | November 2015 |
| Estimated Study Completion Date : | November 2015 |
| Arm | Intervention/treatment |
|---|---|
|
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:
|
- Numeric change of urgency episodes per 24 hours [ Time Frame: 12 weeks of treatment ]
- Changes in voiding diary parameters [ Time Frame: 12 weeks of treatment ]
- Change in symptom questionnaires [ Time Frame: 12 weeks ]
- Patient-Rated Global Assessments of Treatment Benefit, Satisfaction, and Willingness to Continue [ Time Frame: 12 weeks ]
- Change of uroflowmetry and PVR [ Time Frame: 12 weeks ]
- Incidence of acute urinary retention [ Time Frame: during all study periods ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922506
| Contact: Kyu-Sung Lee, Ph.D | 82-2-3410-3554 | ksleedr@skku.edu |
| 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 | |
| Principal Investigator: | Kyu-Sung Lee, Ph.D | Samsung Medical Center |
| Responsible Party: | KYU-SUNG LEE, professor,MD,PhD, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT00922506 History of Changes |
| Other Study ID Numbers: |
2008-08-092 |
| First Posted: | June 17, 2009 Key Record Dates |
| Last Update Posted: | February 16, 2015 |
| Last Verified: | January 2014 |
Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
|
Overactive bladder Benign prostate hyperplasia Doxazosin Tolterodine |
Additional relevant MeSH terms:
|
Hyperplasia Urinary Bladder, Overactive Prostatic Hyperplasia Pathologic Processes Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Prostatic Diseases Genital Diseases, Male Tolterodine Tartrate Doxazosin |
Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents Antihypertensive Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents |