Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study

Male Clinical Trial

— BPH  

Official title:

Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998150
• Other study ID #: 61647
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: March 8, 2019

Study information

• Verified date: June 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.

Description:

To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 8, 2019
• Est. primary completion date: February 14, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients suffering from LUTS secondary to infravesical obstruction from BPH

• failed medical treatment

• International Prostate Symptom Score (IPSS) > 13

• a peak urinary flow rate (Qmax) < 15 ml/sec

• a prostate size = 80 gm

Exclusion Criteria:

• presence of a urethral stricture

• neurological disorder

• bladder cancer

• prostate cancer

• previous history of bladder neck surgery or TURP

Related Conditions & MeSH terms

• BPH With Urinary Obstruction
• Male

Intervention

Procedure:
• Holmium laser enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)
• Bipolar plasma kinetic enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin drop postoperatively (gm/dL)	difference in hemoglobin concentration postoperatively vs preoperatively	Immediate postoperatively
Primary	operative time	operative time in minutes	during surgery
Secondary	complications (%)	intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.	one year
Secondary	urine flow	Qmax (ml/s),	one year
Secondary	post-voiding residual urine	postvoiding residual urine (ml)	one year
Secondary	International prostate symptom score (IPSS)	an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom	one year
Secondary	Quality of life (QoL) section of International prostate symptom score (IPSS)	one question scored from 0 up to 6 (6 is worst)	one year