Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2024
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
Study Start
First participant enrolled
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
November 26, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJune 13, 2025
June 1, 2025
12 months
November 26, 2024
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility
Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.
the operative time
Safety
intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).
1 month
Secondary Outcomes (2)
Efficacy
1 month
Cost Analysis
the operative time
Study Arms (2)
Bipolar Enucleation
Bipolar Enucleation Group: The bipolar energy will be used for cutting and coagulation during enucleation.
Laser Enucleation
Laser Enucleation Group: Thulium or Holmium laser will be employed for tissue dissection and hemostasis.
Interventions
Device: A single working element compatible with both bipolar and laser modalities. The bipolar energy will be used for cutting and coagulation during enucleation.
Device: A single working element compatible with both bipolar and laser modalities. Thulium or Holmium laser will be employed for tissue dissection and hemostasis.
Eligibility Criteria
the study will include male patients aged ≥50 years who are diagnosed with benign prostatic hyperplasia (BPH) , prostate volume ≥40 cc without 4prior history of prostate cancer while patients with ongoing urinary tract infections, prior prostate surgeries, coagulopathy or urethral strictures were excluded.
You may qualify if:
- Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.
- Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
- No prior history of prostate cancer.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Menoufia Faculty of Medicine
Shibīn al Kawm, Menoufia, 13829, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
November 26, 2024
First Posted
June 13, 2025
Study Start
October 1, 2024
Primary Completion
September 30, 2025
Study Completion
November 1, 2025
Last Updated
June 13, 2025
Record last verified: 2025-06