NCT06922968

Brief Summary

The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Apr 2025Oct 2026

First Submitted

Initial submission to the registry

March 17, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

March 17, 2025

Last Update Submit

April 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • efficacy of endoscopic treatment of BPH

    Intervention efficacy will be evaluated by comparing the Peak flow rate in ml/second.(measured by uroflowmetry) between the two groups

    At 12 weeks after the procedure

Study Arms (2)

Control group

EXPERIMENTAL

Control cases under went TURP and enucleation

Procedure: Standard TURP and enucleation

TRUS Guided group

EXPERIMENTAL

TRUS guided group during TURP and enucleation

Procedure: TRUS-Guided TURP and enucleation

Interventions

realtime TRUS guidance during the procedure (TURP and enucleation)

TRUS Guided group

No TRUS guidance during the procedure (TURP and enucleation)

Control group

Eligibility Criteria

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

You may qualify if:

  • Male patients aged 50-80 years
  • Diagnosed with benign prostatic hyperplasia (BPH) and scheduled for TURP or prostatic adenoma enucleation.
  • The patients have clear indication for endoscopic surgery (according to the guidelines).
  • Clinically fit patients for surgery.
  • Signed an informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed Mohamed Abdel-Moniem Hassanein, professor of Urology

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohamed mostafa Elsharkawy, assistant lecturer of Urology

CONTACT

Mahmoud Farouk Hassan, lecturer Of Urology

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 17, 2025

First Posted

April 11, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

to put protect privacy of participants

Locations