The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate

• ClinicalTrials.gov Identifier: NCT04848181
• Recruitment Status: Completed
• First Posted: April 19, 2021
• Last Update Posted: July 21, 2021
• Sponsor: Benha University
• Information provided by (Responsible Party): Shabieb Ahmed, Benha University

Study Description

Brief Summary:

Perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP

Condition or disease	Intervention/treatment	Phase
Prostate Hyperplasia	Drug: cyproterone acetate; Drug: finasteride; Drug: no treatment received	Early Phase 1

Detailed Description:

This prospective randomized controlled study to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate
• Actual Study Start Date: July 1, 2019
• Actual Primary Completion Date: July 1, 2020
• Actual Study Completion Date: July 9, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: cyproterone acetate; 20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP	Drug: cyproterone acetate; two weeks Cyproterone acetate administration before TURP
Active Comparator: finasteride group; 20 patients received finasteride 5 mg once per day for two weeks before TURP	Drug: finasteride; two weeks finasteride administration before TURP
Placebo Comparator: control group; 20 patients received no treatment before TURP	Drug: no treatment received; no treatment received before TURP

Outcome Measures

Primary Outcome Measures :

1. post operative Hb [ Time Frame: 24 hour post operative ]
   measuring serum haemoglobin level at first post operative
2. post operative Hcv [ Time Frame: 24 hour post operative ]
   measuring serum haematocrit value at first post operative
3. operative duration [ Time Frame: immediately after surgery ]
   assessment of the duration of the operation
4. microvascular density(MVD) [ Time Frame: 2 weeks after drug intake ]
   assesment of MVD of the prostate by histological examination using high power field microscope
5. intraoperative blood loss [ Time Frame: immediately after surgery ]
   assessment of intraoperative blood loss during TURP

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Patients with benign prostatic hyperplasia with prostate size (60-100) grams
• Lower urinary tract symptoms (LUTS) not responding to medical treatment
• Recurrent prostatic bleeding
• Recurrent acute urinary retention
• Chronic urinary retention

Exclusion Criteria:

• Patients with coagulation disorders
• Previous prostatic surgery
• Previous finasteride administration
• Bladder pathology (urinary bladder stones - bladder mass)
• Suspected or proved cancer prostate
• Hepatic or renal impairment
• Patients unfit for operation eg. Decompensated heart failure, poor chest condition

Contacts and Locations

Locations

Egypt

Benha University

Banhā, Qalyubia, Egypt, 15311

Sponsors and Collaborators

Benha University

Investigators

• Study Director: shabieb ahmed, Ph.D; faculty of medicine benha university
• Study Director: abdallah fathy, Ph.D; faculty of medicine benha university
• Study Chair: mohamed hefnawy, Ph.D; faculty of medicine benha university
• Principal Investigator: adel al falah, Ph.D; faculty of medicine benha university

More Information

Publications:

Treharne C, Crowe L, Booth D, Ihara Z. Economic Value of the Transurethral Resection in Saline System for Treatment of Benign Prostatic Hyperplasia in England and Wales: Systematic Review, Meta-analysis, and Cost-Consequence Model. Eur Urol Focus. 2018 Mar;4(2):270-279. doi: 10.1016/j.euf.2016.03.002. Epub 2016 Mar 23.

Yang TY, Chen M, Lin WR, Li CY, Tsai WK, Chiu AW, Ko MC. Preoperative treatment with 5α-reductase inhibitors and the risk of hemorrhagic events in patients undergoing transurethral resection of the prostate - A population-based cohort study. Clinics (Sao Paulo). 2018 Mar 12;73:e264. doi: 10.6061/clinics/2018/e264.

Khwaja MA, Nawaz G, Muhammad S, Jamil MI, Faisal M, Akhter S. The Effect of Two Weeks Preoperative Finasteride Therapy in Reducing Prostate Vascularity. J Coll Physicians Surg Pak. 2016 Mar;26(3):213-5. doi: 03.2016/JCPSP.213215.

Tian HL, Zhao CX, Wu HY, Xu ZX, Wei LS, Zhao RT, Jin DL. Finasteride reduces microvessel density and expression of vascular endothelial growth factor in renal tissue of diabetic rats. Am J Med Sci. 2015 Jun;349(6):516-20. doi: 10.1097/MAJ.0000000000000451.

• Responsible Party: Shabieb Ahmed, shabieb ahmed ( assistant professor - urology department - Benha University), Benha University
• ClinicalTrials.gov Identifier: NCT04848181
• Other Study ID Numbers: benign prostatic hyperplasia
• First Posted: April 19, 2021
• Last Update Posted: July 21, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases; Cyproterone Acetate; Finasteride; Cyproterone; 5-alpha Reductase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Urological Agents; Androgen Antagonists; Antineoplastic Agents; Contraceptive Agents, Male; Contraceptive Agents; Reproductive Control Agents