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Clinical Trials in Egypt / NCT07911501
Starting soon Phase 4

Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.

NCT07911501 · tracked via the Priya Life Science Egypt tracker
Sponsor
Mohamed Mahmoud Dogha
Phase
Phase 4
Started
2026-10-21
Last updated
2026-11-02

Condition(s) studied

Benign Prostatic HyperplasiaPostoperative HemorrhagePerioperative Hemorrhage Control During Bipolar Transurethral Resection of the Prostate (TURP) in Patients on Anticoagulant or Antiplatelet Therapy

Investigational drug(s) / intervention(s)

Dutasteride (0.5mg) →Placebo

Dutasteride (0.5mg): Dutasteride 0.5 mg oral capsule (brand name Avodart; 0.5 mg daily for 2 weeks pre-op and 2 weeks post-op)

Placebo: Identical physical appearance and dosing schedule matching the active drug arm (1 capsule daily for 2 weeks preoperatively, followed by Bipolar TURP, and continued for 2 weeks postoperatively).

Study summary

A prospective, randomized, double-blinded controlled trial to evaluate the efficacy of a 2-week preoperative and 2-week postoperative course of oral dutasteride (0.5 mg daily) in reducing perioperative blood loss, irrigation requirements, and catheterization time in patients on anticoagulant therapy undergoing bipolar TURP for benign prostatic hyperplasia (BPH).

Eligibility

Sex
MALE
Min age
50 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1 - Male patients aged \> 50 years. 2-Patients currently receiving oral anticoagulant or antiplatelet therapy. 3- Scheduled for bipolar TURP for symptomatic benign prostatic hyperplasia. 4-Prostate size \> 50 g (measured by pelvi-abdominal or transrectal ultrasonography). Exclusion Criteria: 1. Concomitant urethral stricture. 2. Previous prostatic surgical or endoscopic procedures. 3. Known or suspected prostate cancer. 4. High-risk cardiac condition. 5. Severe hepatic impairment or significant liver disease. 6. Severe renal impairment (including patients on hemodialysis). 7. Active, untreated urinary tract infection.

Primary outcome measure(s)

  • Change in Hemoglobin (Hb) Level — Baseline (preoperative), immediately postoperatively, and 24 hours postoperatively.
    Mean difference in serum Hb (g/dL) from baseline.
  • Change in Hematocrit (Hct) Level — Baseline (preoperative), immediately postoperatively, and 24 hours postoperatively.
    Mean difference in Hct from baseline.

Trial sites (1)

FacilityCityRegionStatus
Mohamed Mahmoud Dogha Al Fayyum Egypt

Other trials for the same condition

Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention Recruiting
Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia Recruiting
Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Prostate Cancer Recruiting
Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH Recruiting
Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover Trial Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07911501 on ClinicalTrials.gov ↗ ← All trials in Egypt