Status:
COMPLETED
Combination Treatment With Doxazosin Plus TolterodineSR 2 mg Versus 4mg in Men With an Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH)
Lead Sponsor:
Samsung Medical Center
Conditions:
Overactive Bladder
Benign Prostatic Hyperplasia
Eligibility:
MALE
50-80 years
Phase:
PHASE4
Brief Summary
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 compl...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00922506
Start Date
May 1 2009
End Date
June 1 2014
Last Update
December 2 2019
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710