Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study

Recruiting

• Conditions: Prostate; BPH (Benign Prostatic Hyperplasia)

• Registration Number: NCT07020364
• Lead Sponsor: Menoufia University

Brief Summary

A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Study First Submitted: 2024-11-26
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.
• Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
• No prior history of prostate cancer.

Exclusion Criteria

• Patients with ongoing urinary tract infections.
• Prior prostate surgeries.
• Coagulation disorders or patients on long-term anticoagulation therapy.
• Known urethral strictures or other anatomical abnormalities complicating endoscopic procedures.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility	the operative time	Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.
Safety	1 month	intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).

Secondary Outcome Measures

Name	Time	Method
Cost Analysis	the operative time	Cost of using a single working element vs. standard separate tools for bipolar and laser.
Efficacy	1 month	Operative time. Enucleation efficiency (grams of tissue removed per minute). Postoperative symptom improvement measured using International Prostate Symptom Score (IPSS).

Trial Locations

Locations (1)

Menoufia Faculty of Medicine; 🇪🇬 Shibin Al Kawm, Menoufia, Egypt