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Clinical Trials/IRCT20100817004582N8
IRCT20100817004582N8
Recruiting
Phase 4

Comparative study on the effectiveness and safety of tamsulosin Oral-Controlled Absorption System (OCAS®) with tamsulosin Modified Release (MR) and placebo in improving lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH)

rology Research Centre, Guilan University of Medical Sciences0 sites260 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
rology Research Centre, Guilan University of Medical Sciences
Enrollment
260
Status
Recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
rology Research Centre, Guilan University of Medical Sciences

Eligibility Criteria

Inclusion Criteria

  • •Patients who are at least 40 years of age.
  • •Prostate\-Specific Antigen (PSA) score should be at age\-specific range.
  • •International Prostate Symptom Score (IPSS) should be greater than or equal to 8\.
  • •The maximum urine flow (Qmax) should be in the range of greater than and/or equal to 4 ml/s and smaller and/or equal to 15 ml/s.
  • •The urine residual should be below 120 ml.

Exclusion Criteria

  • •History of prostatectomy
  • •Severe liver dysfunction
  • •Severe renal dysfunction
  • •Severe cardiovascular dysfunction
  • •History of syncope.
  • •Other conditions that can be causing voiding dysfunction, such as neurogenic bladder, bladder or urinary stones, frequent urinary tract infection, bladder cancer, prostate cancer, urethral stenosis, and large diverticulum bladder.
  • •History of allergy to tamsulosin
  • •History of recent retention and nocturnal polyuria
  • •Patients with benign prostatic hyperplasia (BPH) who are candidates for surgery on the basis of clinical and paraclinical symptoms.
  • •History of use of 5a\-reductase inhibitors in the last 3 months

Outcomes

Primary Outcomes

Not specified

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