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

• Sponsor: Benha University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04848181
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Actual Duration (Months): 12.3
• Patients Per Site Per Month: 4.9

Study Details

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
• 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: Jul 1, 2019
• Actual Primary Completion Date: Jul 1, 2020
• Actual Study Completion Date: Jul 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 [24 hour post operative]

   measuring serum haemoglobin level at first post operative

2. post operative Hcv [24 hour post operative]

   measuring serum haematocrit value at first post operative

3. operative duration [immediately after surgery]

   assessment of the duration of the operation

4. microvascular density(MVD) [2 weeks after drug intake]

   assesment of MVD of the prostate by histological examination using high power field microscope

5. intraoperative blood loss [immediately after surgery]

   assessment of intraoperative blood loss during TURP

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• 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: Apr 19, 2021
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 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; Cyproterone Acetate; Finasteride; Cyproterone

Study Results

No Results Posted as of Jul 21, 2021