Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH
Standard Versus Transrectal Ultrasound (TRUS)-Guided Endoscopic Treatment of Benign Prostatic Hyperplasia: A Prospective Randomized Controlled Trial
1 other identifier
interventional
114
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
1 active site
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
First Submitted
Initial submission to the registry
March 17, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
April 11, 2025
April 1, 2025
1.5 years
March 17, 2025
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
EXPERIMENTALControl cases under went TURP and enucleation
TRUS Guided group
EXPERIMENTALTRUS guided group during TURP and enucleation
Interventions
realtime TRUS guidance during the procedure (TURP and enucleation)
No TRUS guidance during the procedure (TURP and enucleation)
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmed Mohamed Abdel-Moniem Hassanein, professor of Urology
Assiut University
Central Study Contacts
Mohamed mostafa Elsharkawy, assistant 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