NCT02332538

Brief Summary

Most guidelines are not strict for recommending single treatment approach for Moderate to large prostate. In this study the investigators planned to test the Greenlight (532-nm) laser Photoselective Vapo-Enucleation of the Prostate (PVEP) using (XPS) 180W system compared to bipolar transurethral resection of the prostate (TURis) and Holmium Laser Enucleation of the Prostate (HOLEP) in reduction of lower urinary tract symptoms (LUTS) secondary to BPH in a prospective randomized trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

December 27, 2014

Last Update Submit

October 13, 2019

Conditions

Benign Prostate HyperplasiaLower Urinary Tract Symptoms

Keywords

LASERPROSTATEBIPOLARHYPERPLASIAVAPORIZATION

Outcome Measures

Primary Outcomes (1)

  • Re treatment

    need for retreatment for recurrent infravesical obstruction following primary surgery

    3 YEARs

Secondary Outcomes (2)

  • change in symptoms score

    3 year

  • Urine Flow rate (ml/sec)

    3 year

Study Arms (3)

Greenlight (532nm-laser) PVEP

ACTIVE COMPARATOR

532nm-laser photoselective vapo-enucleation of the prostate)

Procedure: 532nm-laser photoselective vapo-enucleation of the prostate)

Holmium laser enucleation of prostate

ACTIVE COMPARATOR

Holmium-Yag laser enucleation of the prostate

Procedure: Holmium laser enucleation of prostate

Bipolar TURP

ACTIVE COMPARATOR

Bipolar transurethral resection of the prostate in saline

Procedure: Bipolar TURP

Interventions

532nm-laser photoselective vapo-enucleation of the prostate)PROCEDURE

using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)

Greenlight (532nm-laser) PVEP
Holmium laser enucleation of prostatePROCEDURE

Holmium-Yag laser enucleation of the prsotate

Holmium laser enucleation of prostate
Bipolar TURPPROCEDURE

Bipolar transurethral resection of the prostate in saline

Bipolar TURP

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients' age ≥50 years
  • LUTS secondary to BOO due to BPH who failed medical treatment
  • International prostate symptom scores 8 (IPSS) \>15 and bother score 8 (QOL) ≥ 3 (according to IPSS question 8)
  • Peak urinary flow rate (Qmax) \<15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
  • ASA (American society of anaesthesiologists) score ≤3.
  • TRUS prostate size (\>/=80ml)

You may not qualify if:

  • Patient with 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 prostate cancer 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract SymptomsHyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Ahmed M Elshal, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 27, 2014

First Posted

January 7, 2015

Study Start

March 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2019

Last Updated

October 16, 2019

Record last verified: 2019-10

Locations

EG(1)