NCT02243540

Brief Summary

The aim of this study was to evaluate an impact of preoperative bladder underactivity on treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to compare it between the two types of surgery for benign prostatic hyperplasia.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
1,828

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

September 14, 2014

Last Update Submit

September 15, 2014

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline bladder voiding efficiency at 12 months after surgery

    bladder voiding efficiency = voided volume x 100 / (voided volume + post-void residual urine volume)

    12-months postoperatively

Eligibility Criteria

Age40 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

men who underwent photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia refractory to medical treatment

You may qualify if:

  • patients in whom 12-month follow-up data were available

You may not qualify if:

  • a previous diagnosis of urethral stricture
  • prostate or bladder carcinoma
  • neurogenic bladder disease
  • a previous history of urological surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jae-Seung Paick, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae-Seung Paick, M.D., Ph.D.

CONTACT

82-2-2072-2422jspaick@snu.ac.kr

Study Design

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

Study Record Dates

First Submitted

September 14, 2014

First Posted

September 18, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

KR(1)