Serum Prostatic Specific Antigen Changes After Bipolar and Monopolar TURP

Serum Prostatic Specific Antigen (PSA) Changes After Bipolar and Monopolar Transurethral Resection of the Benign Prostatic Hyperplasia, a Randomized Controlled Study.

To use PSA levels after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia as an indicator of the quality of resection .

Study Overview

• Status: Not yet recruiting
• Conditions: PSA Changes After TURP
• Intervention / Treatment: Procedure: TURP

Detailed Description

PSA is a protein produced from the prostate epithelium and secreted in semen in huge amounts , small amount find its way to the circulation ,its function is to allow mobility of the sperms by interacting with the Semenogelin . clinical BPH can be defined as prostate adenoma/adenomata, causing a varying degree of BOO, which may eventually cause harm to the patients ,Treatment of this condition varies from conservative, medical and surgical depending on factors related to the patient and the surgeon preference . The early reports of minimally invasive treatment of the prostate dated back to 1937, since then and remarkable development is noticed . TURP is the golden treatment in the BPH . Studies compare between the methods according the blood transfusion , operation time retention after catheter removal , urethral complications , TUR syndrome and hospital-stay which show that bipolar is better. To our knowledge after few studies compare between the techniques according PSA also these studies show weakness in their statistically analysis with no difference between the methods .investigators aim is to study the effect of the operations on PSA levels as an indicator of the quality of resection.

• Study Type: Interventional
• Enrollment (Anticipated): 2
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew H Wahba Gerges, Resident doctor; Phone Number: 01287793663 +201015349430; Email: androwhamam1234@gmail.com
• Study Contact Backup: Name: Mahmoud M Shalaby, professor; Phone Number: +201111222203; Email: shalabymm@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients agreeing to participate, clinically fit, age from 50 to 80 years with LUTS related to benign prostate enlargement with no neurological disorder

Exclusion Criteria:

• Prostate cancer
• Previous urethral or prostate surgery
• Neurogenic bladder
• Urethral stricture
• Patient unfit for surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bipolar TURP; Patients thats will undergo bipolar TURP	Procedure: TURP; Bipolar and monopolar transurethral resection of the benign prostatic hyperplasia
Active Comparator: Monopolar TURP; Patients thats will undergo monopolar TURP	Procedure: TURP; Bipolar and monopolar transurethral resection of the benign prostatic hyperplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum PSA changes after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia	To use PSA levels changes after both techniques (bipolar and monopolar transurethral resection of the benign prostatic hyperplasia)as an indicator of the quality of resection	within one month after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score	International Prostate Symptom Score after bipolar and monopolar transurethral resection of the benign prostatic hyperplasia	within one month after intervention

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed A Elgamal, professor, Assiut University

Publications and helpful links

General Publications

• Geavlete B, Georgescu D, Multescu R, Stanescu F, Jecu M, Geavlete P. Bipolar plasma vaporization vs monopolar and bipolar TURP-A prospective, randomized, long-term comparison. Urology. 2011 Oct;78(4):930-5. doi: 10.1016/j.urology.2011.03.072. Epub 2011 Jul 29.
• Pahwa M, Pahwa M, Pahwa AR, Girotra M, Chawla A, Sharma A. Changes in S-PSA after transurethral resection of prostate and its correlation to postoperative outcome. Int Urol Nephrol. 2013 Aug;45(4):943-9. doi: 10.1007/s11255-013-0474-3. Epub 2013 May 24.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 7, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PSA Changes after TURP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No