Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03460873
Collaborator
(none)
432
1
50.9
8.5
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
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
:
Sep 1, 2015
Actual Primary Completion Date
:
Nov 7, 2019
Actual Study Completion Date
:
Nov 28, 2019
Outcome Measures
Primary Outcome Measures
- Comparison of IPSS(International Prostate Symptom Score) changes [pre-operation and post-operation (3month, 6month)]
Complete the questionnaire(IPSS) before and after the treatment
Secondary Outcome Measures
- changes of voided urine volume [pre-operation and post-operation (3month, 6month)]
Comparison of voided urine volume
- changes of residual urine volume [pre-operation and post-operation (3month, 6month)]
Comparison of residual urine volume
- Occurrence of adverse event [post-operation (3month, 6month)]
collection of adverse event
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Male patient scheduled to undergo prostatectomy using holmium laser
Exclusion Criteria:
- Urethral stricture, large bladder diverticulum, bladder neck contracture
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | Korea, Republic of | 135-710 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
KYU-SUNG LEE,
Professor,
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT03460873
Other Study ID Numbers:
- 2015-11-037
First Posted:
Mar 9, 2018
Last Update Posted:
Dec 2, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: