Holmium Laser Enucleation of Prostate(HOLEP) vs Greenlight(XPS) Laser Photoselective Vapo-Enucleation of Prostate(PVEP)

NCT01494337 | Completed Phase 4

• 1 other identifier: 11-171-SDR
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are now proposing to compare two laser techniques for treating Benign prostate hyperplasia (BPH); Holmium Laser Enucleation of the Prostate (HOLEP) versus (greenlight) XPS which is a recently available technology in our center and is more efficient hence our choice to include patients with any size prostate. This will confirm whether the two techniques are equivalent in efficacy and safety independent of size as well as cost. The two techniques are available world wide as standard of care

Conditions

Benign Prostate Hyperplasia

Keywords

LASER; BPH; Prostate surgery; HOLEP; Green light PVP

Outcome Measures

Primary Outcomes (1)

• change in urine flow parameters

  change in urine flow parameters; IPSS= international prostate symptom score QOL= quality of life score PVR= post voiding residual urine Q-MAX= maximal flow rate

  one, 4 and 12 months postoperative

Secondary Outcomes (2)

• TIME TO CATHETER REMOVAL, HOSPITAL STAY

  1 day post operative

• the need for redo surgery

  1 year

Study Arms (2)

HOLEP

ACTIVE COMPARATOR

HOLEP In the first arm, holmium laser enucleation of the prostate will be done

Procedure: HOLEP

PVEP/XPS

ACTIVE COMPARATOR

PVEP/XPS green light photoselective Vapo-Enucleation of prostate using XPS 180W machine will be used in the second arm

Procedure: PVEP-XPS

Interventions

HOLEP PROCEDURE

USING HOLMIUM LASER, the prostate adenoma will be enucleated and removed into small pieces

Also known as: Holmium Laser Enucleation of The Prostate

HOLEP

PVEP-XPS PROCEDURE

Greenlight laser will be used with high power setting for selective vaporization of the prostate adenoma, using 180 watt XPS laser machine

Also known as: Photoselective Vapo-Enucleation of prostate(PVEP)

PVEP/XPS

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give informed consent.
• Lower urinary symptoms (LUTS) secondary to bladder outlet obstruction from BPH.
• Failed medical treatment of BPH.
• International prostate symptom scores (IPSS) \> 15.
• Peak urinary flow rate (Qmax) \< 15 ml/sec.
• Preoperative TRUS (transrectal ultrasound) size of the gland (from 40 to 150 cc).
• Patients in retention secondary to BPH (with cystometrogram (CMG) confirming adequate detrusor pressure if the bladder capacity at time of catheterization is in excess of 1000 ml).

You may not qualify if:

• Inability to give informed consent.
• Patient who have a neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease.
• Active urinary tract infection.
• Presence of active bladder cancer (within the last 2 years).
• Known cancer prostate patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.

Sponsors & Collaborators

• Royal Victoria Hospital, Canada: lead
• McGill University: collaborator

Study Sites (1)

Royal victoria hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

• Elshal AM, Elkoushy MA, El-Nahas AR, Shoma AM, Nabeeh A, Carrier S, Elhilali MM. GreenLight laser (XPS) photoselective vapo-enucleation versus holmium laser enucleation of the prostate for the treatment of symptomatic benign prostatic hyperplasia: a randomized controlled study. J Urol. 2015 Mar;193(3):927-34. doi: 10.1016/j.juro.2014.09.097. Epub 2014 Sep 28.

  PMID: 25261801 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mostafa M Elhilali, Professor

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 19, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

CA (1)