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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doxazosin plus tolterodine SR 2 mg | Experimental | doxazosin plus tolterodine SR(2 mg, qd) for 12 weeks |
|
| doxazosin plus tolterodine SR 4 mg | Experimental | doxazosin plus tolterodine SR(4 mg,qd) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxazosin plus tolterodine SR | Drug | doxazosin plus tolterodine SR(2 mg, qd)for 12 weeks or (4 mg, qd) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric change of urgency episodes per 24 hours | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in voiding diary parameters | 12 weeks of treatment | |
| Change in symptom questionnaires | 12 weeks | |
| Patient-Rated Global Assessments of Treatment Benefit, Satisfaction, and Willingness to Continue |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Sung Lee, Ph.D | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37160401 | Derived | Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3. |
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|
| 12 weeks |
| Change of uroflowmetry and PVR | 12 weeks |
| Incidence of acute urinary retention | during all study periods |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D017292 | Doxazosin |
| ID | Term |
|---|---|
| D011224 | Prazosin |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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