HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH

Male Clinical Trial

Official title:

Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04935151
• Other study ID #: REC-TBRI-PT563
• Status: Completed
• Phase: N/A
• Start date: December 4, 2016
• Est. completion date: March 10, 2021

Study information

• Verified date: June 2021
• 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 symptomatic large BPH (> 80 gm)

Description:

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (> 80 gm)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 10, 2021
• Est. primary completion date: March 6, 2018
• 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 with 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
• Bipolar resection of the prostate
cystoscopic transurethral resection of the prostate using bipolar energy

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo
Egypt	Theodor Bilharz research institute	Giza

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
Other	complications (percent)	All complications	Three years
Other	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	Three years
Other	Quality of life (QoL)	section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)	Three years
Other	flowmetry	rate of flow (ml urine) per second	Three years
Primary	hemoglobin drop postoperatively (gm/dL)	change in hemoglobin concentration postoperatively vs preoperatively	within two hours after surgery
Secondary	operative duration in minutes	operative duration	Time lapsed during surgery
Secondary	Hospital stay	Hospitalisation starting from day of surgery till the day of discharge from Hospital in days	From time of randomisation up to last day of admission in hospital (in days) up to 30 days
Secondary	blood transfusion	rate of blood transfusion	during surgery and hospitalisation up to 10 days