Back to resultsThe Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate
Primary Purpose
Prostate Hyperplasia
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
cyproterone acetate
finasteride
no treatment received
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Hyperplasia
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
Sites / Locations
- Benha University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
cyproterone acetate
finasteride group
control group
Arm Description
20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP
20 patients received finasteride 5 mg once per day for two weeks before TURP
20 patients received no treatment before TURP
Outcomes
Primary Outcome Measures
post operative Hb
measuring serum haemoglobin level at first post operative
post operative Hcv
measuring serum haematocrit value at first post operative
operative duration
assessment of the duration of the operation
microvascular density(MVD)
assesment of MVD of the prostate by histological examination using high power field microscope
intraoperative blood loss
assessment of intraoperative blood loss during TURP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04848181
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
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
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cyproterone acetate
Arm Type
Active Comparator
Arm Description
20 patients received cyproterone acetate 50 mg twice per day for two weeks before TURP
Arm Title
finasteride group
Arm Type
Active Comparator
Arm Description
20 patients received finasteride 5 mg once per day for two weeks before TURP
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
20 patients received no treatment before TURP
Intervention Type
Drug
Intervention Name(s)
cyproterone acetate
Intervention Description
two weeks Cyproterone acetate administration before TURP
Intervention Type
Drug
Intervention Name(s)
finasteride
Intervention Description
two weeks finasteride administration before TURP
Intervention Type
Drug
Intervention Name(s)
no treatment received
Intervention Description
no treatment received before TURP
Primary Outcome Measure Information:
Title
post operative Hb
Description
measuring serum haemoglobin level at first post operative
Time Frame
24 hour post operative
Title
post operative Hcv
Description
measuring serum haematocrit value at first post operative
Time Frame
24 hour post operative
Title
operative duration
Description
assessment of the duration of the operation
Time Frame
immediately after surgery
Title
microvascular density(MVD)
Description
assesment of MVD of the prostate by histological examination using high power field microscope
Time Frame
2 weeks after drug intake
Title
intraoperative blood loss
Description
assessment of intraoperative blood loss during TURP
Time Frame
immediately after surgery
10. Eligibility
Sex
Male
Gender Based
Yes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shabieb ahmed, Ph.D
Organizational Affiliation
faculty of medicine benha university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
abdallah fathy, Ph.D
Organizational Affiliation
faculty of medicine benha university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mohamed hefnawy, Ph.D
Organizational Affiliation
faculty of medicine benha university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
adel al falah, Ph.D
Organizational Affiliation
faculty of medicine benha university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Benha University
City
Banhā
State/Province
Qalyubia
ZIP/Postal Code
15311
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
28753756
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.
Results Reference
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PubMed Identifier
29538495
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.
Results Reference
background
PubMed Identifier
26975954
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.
Results Reference
background
PubMed Identifier
25789687
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.
Results Reference
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The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate
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