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Clinical Trials/KCT0000077
KCT0000077
Recruiting
未知

Comparative Study on the Efficacy and Safety of Initial Combination Therapy of Low Dose Propiverine Hydrocholoride Compared to Alpha-antagonist Monotherapy in men with BPH with Overactive bladder: A Prospective Placebo Controlled Study

Inha University Hospital0 sites236 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Diseases of The genitoruinary system
Sponsor
Inha University Hospital
Enrollment
236
Status
Recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

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

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. signed Informed consent form
  • 2\. Male aged more than 45
  • 3\. IPSS more than 12
  • 4\. Enlarged prostate on DRE
  • 5\. Symptoms of urinary urgency with voiding 3/day
  • 6\. Symptoms of urinary frequency (8 micturitions per 24 hours)
  • 7\. Symptoms of LUTS more than 3 months
  • 8\. understanding and agreed the purpose of trial

Exclusion Criteria

  • 1\. Total daily urine volume of \> 3000 ml
  • 2\. Initial RU more than 150ml
  • 3\. Significant hepatic or renal disease
  • (twice the upper limit of the reference ranges for serum concentrations of AST \[SGOT], ALT \[SGPT], alkaline phosphatase or creatinine)
  • 4\. Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow\-angled glaucoma, urinary retention or gastric retention
  • 5\. Symptomatic acute urinary tract infection (UTI) during the run\-in period
  • 6\. Recurrent UTIs defined as having been treated for symptomatic UTIs \> 4 times in the last year
  • 7\. Diagnosed or suspected interstitial cystitis
  • 8\. Clinically significant hematuria or hematuria secondary to malignant disease.
  • 9\. PSA more than 10ng/dl (can include PSA between 4 and 10 if biopsy is negative)

Outcomes

Primary Outcomes

Not specified

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