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Search / Trial NCT04107896

Efficacy of Silodosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

Launched by BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY, DHAKA, BANGLADESH · Sep 26, 2019

Trial Information

Current as of May 29, 2025

Completed

Keywords

ClinConnect Summary

Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms in elderly men. Selective α1-adrenergic antagonists are now first-line drugs in the medical management of BPH. This Hospital based randomized controlled clinical study designed to evaluate the efficacy of the new α1-blocker silodosin in the treatment of symptomatic benign prostatic hyperplasia (BPH).Ambulatory patients of age between 50 to 70 years, who were diagnosed as benign prostatic hyperplasia, were divided into two groups after fulfilling selection criteria. After informed consent \& random sam...

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Ambulatory male patients between 50 to 70 years and had diagnosis of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH)
  • International prostate symptoms score (IPSS)≥ 8
  • Peak urinary flow rate (Qmax)\<15ml/sec for a voided volume of 150 ml or more
  • Post voidal residual urine volume ≥ 50 ml (by transabdominal ultrasonogram)
  • Volume of prostate determine by transabdominal ultrasonogram ≥ 30 gm
  • Exclusion Criteria:
  • History of prostate cancer/raised PSA\>4 ng/ml
  • Previous prostate surgery /Periurethral surgery.
  • Patient undergone surgery to the bladder neck/Bladder neck contracture.
  • Urethral stricture
  • History of LUTS not due to benign prostatic hyperplasia (BPH).
  • Postvoid residual urine volume of \>150ml
  • Bladder stone
  • Active urinary tract infection which might affect micturition
  • Large intravesical protrusion \> 2 cm
  • Known hypersensitivity or history of active substance abuse

About Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Bangabandhu Sheikh Mujib Medical University (BSMMU) in Dhaka, Bangladesh, is a premier institution dedicated to advancing medical education, research, and healthcare services. As a leading clinical trial sponsor, BSMMU is committed to fostering innovative research initiatives that enhance patient care and contribute to the global medical community. The university boasts a multidisciplinary team of experts and state-of-the-art facilities, enabling the conduct of rigorous clinical trials across various therapeutic areas. With a focus on ethical standards and patient safety, BSMMU aims to facilitate the development of new treatments and improve health outcomes both locally and internationally.

Locations

Dhaka, , Bangladesh

Patients applied

0 patients applied

Trial Officials

maidul islam, resident

Principal Investigator

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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