Holmium Laser Versus Bipolar Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Large Prostates: A Non-inferiority Prospective Randomized Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:
• Age \>50 years
• Prostate volume \>80 ml
• Failure of or noncompliance with medical treatment
• IPSS \>15
• Qmax \<15 ml/sec
• Urinary retention and fixed catheters with poor results on trial of voiding without catheter
Locations
Other Locations
Egypt
Assiut University Urology Hospital
RECRUITING
Asyut
Contact Information
Primary
Mostafa M. Mostafa, M.D.
mostafaabdelaziz91@gmail.com
+201000740478
Backup
Mohammad A. Abd ElMoneim, M.D.
mohamed.20134296@med.aun.edu.eg
+201028511082
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 98
Treatments
Active_comparator: Holmium Laser Enucleation of the Prostate (HoLEP)
Half of the BPH patients with large prostate admitted to the study will undergo Holmium Laser Enucleation of the Prostate (HoLEP)
Active_comparator: Bipolar Enucleation of the Prostate (BipolEP)
Half of the BPH patients with large prostate admitted to the study will undergo Bipolar Enucleation of the Prostate (BipolEP)
Related Therapeutic Areas
Sponsors
Leads: Assiut University