Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460873
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

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

Condition or disease Intervention/treatment
Benign Prostatic Hyperplasia (BPH) Procedure: holmium laser enucleation of the prostate

Layout table for study information
Study Type : Observational
Actual Enrollment : 432 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
Actual Study Start Date : September 2015
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : November 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium


Intervention Details:
  • Procedure: holmium laser enucleation of the prostate
    undergo holmium laser enucleation of the prostate


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. changes of voided urine volume [ Time Frame: pre-operation and post-operation (3month, 6month) ]
    Comparison of voided urine volume

  2. changes of residual urine volume [ Time Frame: pre-operation and post-operation (3month, 6month) ]
    Comparison of residual urine volume

  3. Occurrence of adverse event [ Time Frame: post-operation (3month, 6month) ]
    collection of adverse event



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patient scheduled to undergo prostatectomy using holmium laser
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
tertiary hospital
Criteria

Inclusion Criteria:

  • Male patient scheduled to undergo prostatectomy using holmium laser

Exclusion Criteria:

  • Urethral stricture, large bladder diverticulum, bladder neck contracture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460873


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Layout table for additonal information
Responsible Party: KYU-SUNG LEE, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03460873    
Other Study ID Numbers: 2015-11-037
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases