HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial

Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143399
• Other study ID #: 62513
• Status: Completed
• Phase: N/A
• Start date: February 14, 2016
• Est. completion date: June 10, 2019

Study information

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

Clinical Trial Summary

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

Description:

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (> 75 gm).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: June 10, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 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 = 75 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 (Versa pulse 100W; Lumenis; Germany)
• Bipolar resection of the prostate
cystoscopic transurethral resection of the prostate using bipolar energy

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

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 duration in minutes	operative duration	during surgery
Primary	Hospital stay in days	Hospital stay	immediately after surgery
Secondary	complications (%)	intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.	Two years
Secondary	urine flow	Qmax (ml/s),	Two years
Secondary	post-voiding residual urine	postvoiding residual urine (ml)	Two years
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	Two years
Secondary	Quality of life (QoL)	section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)	Two years
Secondary	Catheter duration	Catheter duration in hours	immediate postoperatively