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

NCT ID: NCT04848181

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-07-09

Brief Summary

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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

Detailed Description

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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

Conditions

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Prostate Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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cyproterone acetate

20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP

Group Type ACTIVE_COMPARATOR

cyproterone acetate

Intervention Type DRUG

two weeks Cyproterone acetate administration before TURP

finasteride group

20 patients received finasteride 5 mg once per day for two weeks before TURP

Group Type ACTIVE_COMPARATOR

finasteride

Intervention Type DRUG

two weeks finasteride administration before TURP

control group

20 patients received no treatment before TURP

Group Type PLACEBO_COMPARATOR

no treatment received

Intervention Type DRUG

no treatment received before TURP

Interventions

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cyproterone acetate

two weeks Cyproterone acetate administration before TURP

Intervention Type DRUG

finasteride

two weeks finasteride administration before TURP

Intervention Type DRUG

no treatment received

no treatment received before TURP

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Shabieb Ahmed

shabieb ahmed ( assistant professor - urology department - Benha University)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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shabieb ahmed, Ph.D

Role: STUDY_DIRECTOR

faculty of medicine, Benha university

abdallah fathy, Ph.D

Role: STUDY_DIRECTOR

faculty of medicine, Benha university

mohamed hefnawy, Ph.D

Role: STUDY_CHAIR

faculty of medicine, Benha university

adel al falah, Ph.D

Role: PRINCIPAL_INVESTIGATOR

faculty of medicine, Benha university

Locations

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Benha University

Banhā, Qalyubia Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 28753756 (View on PubMed)

Yang TY, Chen M, Lin WR, Li CY, Tsai WK, Chiu AW, Ko MC. Preoperative treatment with 5alpha-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.

Reference Type BACKGROUND
PMID: 29538495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26975954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25789687 (View on PubMed)

Related Links

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https://www.journal-ina.com/text.asp?2016/3/2/68/181223

Transurethral Resection of Prostate is Still the Gold Standard for Small to Moderate Sized Prostates

Other Identifiers

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benign prostatic hyperplasia

Identifier Type: -

Identifier Source: org_study_id

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