Clinical trial NCT04848181: The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate
Official title: The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Prostate Hyperplasia
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: post operative Hb
timeFrame: 24 hour post operative
measure: post operative Hcv
timeFrame: 24 hour post operative
measure: operative duration
timeFrame: immediately after surgery
measure: microvascular density(MVD)
timeFrame: 2 weeks after drug intake
measure: intraoperative blood loss
timeFrame: immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha University
state: Qalyubia
Study officials:
affiliation: faculty of medicine, Benha university
name: shabieb ahmed, Ph.D
role: STUDY_DIRECTOR
affiliation: faculty of medicine, Benha university
name: abdallah fathy, Ph.D
role: STUDY_DIRECTOR
affiliation: faculty of medicine, Benha university
name: mohamed hefnawy, Ph.D
role: STUDY_CHAIR
affiliation: faculty of medicine, Benha university
name: adel al falah, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.