NCT03460873

Brief Summary

Prognostic factor in the patients with benign prostatic hyperplasia (BPH) who undergo holmium laser enucleation of the prostate

Trial Health

87
On Track

Trial Health Score

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

Enrollment
432

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

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

September 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

4.2 years

First QC Date

February 27, 2018

Last Update Submit

November 28, 2019

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

  • Comparison of IPSS(International Prostate Symptom Score) changes

    Complete the questionnaire(IPSS) before and after the treatment

    pre-operation and post-operation (3month, 6month)

Secondary Outcomes (3)

  • changes of voided urine volume

    pre-operation and post-operation (3month, 6month)

  • changes of residual urine volume

    pre-operation and post-operation (3month, 6month)

  • Occurrence of adverse event

    post-operation (3month, 6month)

Interventions

holmium laser enucleation of the prostatePROCEDURE

undergo holmium laser enucleation of the prostate

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale patient scheduled to undergo prostatectomy using holmium laser
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

tertiary hospital

You may qualify if:

  • Male patient scheduled to undergo prostatectomy using holmium laser

You may not qualify if:

  • Urethral stricture, large bladder diverticulum, bladder neck contracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 9, 2018

Study Start

September 1, 2015

Primary Completion

November 7, 2019

Study Completion

November 28, 2019

Last Updated

December 2, 2019

Record last verified: 2019-11

Locations

KR(1)