NCT02749604

Brief Summary

GreenLight laser PVP currently gains wide acceptance as a minimally invasive treatment for benign prostate enlargment and the emergence of ejaculatory sparing techniques made it feasible to get both benefits: relief of lower urinary tract symptoms and preservation of ejaculation. However evaluation of actual infravesical de-obstruction following such techniques remains a grey zone in the literature without an objective assessment of the degree of de-obstruction. Furthermore, the impact of maintaining ejaculation on different domains of the sexual function using comprehensive assessment tools was not compared in ejaculatory sparring vs. non-ejaculatory sparring approaches.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

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, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

1.5 years

First QC Date

April 20, 2016

Last Update Submit

April 20, 2016

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • ejaculatory function

    the ability to maintain ejaculatory function as depicted by Ej-MSHQ score

    4 months

Secondary Outcomes (2)

  • Bladder outlet obstruction index

    4 months

  • International index of erectile function-15

    4 months

Study Arms (2)

Non-ejaculatory sparring PVP

ACTIVE COMPARATOR

Greenlight laser photoslective vaporization of the prostate

Procedure: Non-ejaculatory sparring PVP

Ejaculatory sparring PVP

EXPERIMENTAL

Greenlight laser photoslective vaporization of the prostate with preservation of the ejaculatory hood

Procedure: Ejaculatory sparring PVP

Interventions

Non-ejaculatory sparring PVPPROCEDURE

Greenlight laser photoslective vaporization of the prostate

Non-ejaculatory sparring PVP
Ejaculatory sparring PVPPROCEDURE

Greenlight laser photoslective vaporization of the prostate with preservation of the ejaculatory hood

Ejaculatory sparring PVP

Eligibility Criteria

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

You may qualify if:

  • To be eligible in the study, patient must fulfill the following criteria:
  • Age ≥ 50 years
  • ASA (American society of anesthesiologists) score ≤3.
  • TRUS estimated prostate weight 30-80 grams.
  • Sexually interested and having continuous relationship with the same partner (interested).
  • BOOI (bladder outlet obstructing index) ≥ 20 as per pressure flow study

You may not qualify if:

  • Patients with any of the following are to be excluded:
  • Preoperative sexual or ejaculatory disturbances or pelvic pain syndrome
  • Documented or suspected prostate cancer (significantly elevated PSA, positive biopsy for prostate cancer guided by TRUS)
  • Neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled DM (\> 10 years) cerebral stroke, Parkinsonism
  • Active urinary tract infection
  • Urodynamic changes consistent with urethropathy or detrusor hypocontractility
  • Previous pelvic surgeries
  • History of pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, DK, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ahmed Elshal

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Elshal, MD

CONTACT

elshalam@hotmail.com

Ahmed alhussein

CONTACT

ahmedalhussein20@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 25, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2017

Study Completion

March 1, 2018

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

EG(1)