NCT05533047

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 5, 2022

Last Update Submit

September 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • International Prostate Symptom Score

    within one month after intervention

Study Arms (2)

Bipolar TURP

ACTIVE COMPARATOR

Patients thats will undergo bipolar TURP

Procedure: TURP

Monopolar TURP

ACTIVE COMPARATOR

Patients thats will undergo monopolar TURP

Procedure: TURP

Interventions

TURPPROCEDURE

Bipolar and monopolar transurethral resection of the benign prostatic hyperplasia

Bipolar TURPMonopolar TURP

Eligibility Criteria

Age50 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mohamed A Elgamal, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Andrew H Wahba Gerges, Resident doctor

CONTACT

Mahmoud M Shalaby, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 8, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

September 8, 2022

Record last verified: 2022-09