Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate

November 28, 2019 updated by: KYU-SUNG LEE, Samsung Medical Center
Prognostic factor in the patients with benign prostatic hyperplasia (BPH) who undergo holmium laser enucleation of the prostate

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

432

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center, Sungkyunkwan University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

tertiary hospital

Description

Inclusion Criteria:

  • Male patient scheduled to undergo prostatectomy using holmium laser

Exclusion Criteria:

  • Urethral stricture, large bladder diverticulum, bladder neck contracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of IPSS(International Prostate Symptom Score) changes
Time Frame: pre-operation and post-operation (3month, 6month)
Complete the questionnaire(IPSS) before and after the treatment
pre-operation and post-operation (3month, 6month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of voided urine volume
Time Frame: pre-operation and post-operation (3month, 6month)
Comparison of voided urine volume
pre-operation and post-operation (3month, 6month)
changes of residual urine volume
Time Frame: pre-operation and post-operation (3month, 6month)
Comparison of residual urine volume
pre-operation and post-operation (3month, 6month)
Occurrence of adverse event
Time Frame: post-operation (3month, 6month)
collection of adverse event
post-operation (3month, 6month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

November 7, 2019

Study Completion (Actual)

November 28, 2019

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 28, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-11-037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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