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NCT03460873 Clinical Trial

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

Benign Prostatic Hyperplasia (BPH) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03460873
Other study ID # 2015-11-037
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date November 28, 2019

Study information
Verified date November 2019
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 432
Est. completion date November 28, 2019
Est. primary completion date November 7, 2019
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Male patient scheduled to undergo prostatectomy using holmium laser

Exclusion Criteria:

- Urethral stricture, large bladder diverticulum, bladder neck contracture

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 changes of voided urine volume Comparison of voided urine volume pre-operation and post-operation (3month, 6month)
Secondary changes of residual urine volume Comparison of residual urine volume pre-operation and post-operation (3month, 6month)
Secondary Occurrence of adverse event collection of adverse event post-operation (3month, 6month)
See also
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Recruiting NCT02592473 - Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia N/A
Completed NCT00945490 - Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018 Phase 3
Completed NCT00759135 - Phase 2 Study of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) (Enlarged Prostate) Phase 2
Completed NCT00224107 - A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo Phase 3
Recruiting NCT04648176 - Application of MOSES Technology in BPH N/A
Terminated NCT00651807 - A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806) Phase 2
Recruiting NCT04766268 - Prostate Artery Embolization: Single Center Experience N/A