NCT02073799

Brief Summary

Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP). However, almost all literature focused on postoperative urgency or dysuria immediately after PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms in the postoperative period after PVP or HoLEP and data on predicting factors that influence improvement in storage symptoms postoperatively. The aim of this study was to compare serial changes of postoperative storage symptoms between PVP and HoLEP, and to identify the predictors that influence improvement of storage symptoms postoperatively.

Trial Health

55
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Trial Health Score

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

Enrollment
486

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2014

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

28 days

First QC Date

February 23, 2014

Last Update Submit

February 25, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • the subtotal storage symptom score of the International Prostate Symptom Score (IPSS)

    a reduction by ≥ 50% of the subtotal storage symptom score according to the International Prostate Symptom Score (IPSS) after the surgery compared to baseline

    12 months after surgery

Study Arms (2)

Photoselective vaporization of the prostate

Patients who underwent photoselective vaporization of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available

Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)

Holmium laser enucleation of the prostate

Patients who underwent holmium laser enucleation of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available

Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)

Interventions

Holmium laser enucleation of the prostatePhotoselective vaporization of the prostate

Eligibility Criteria

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

Patients who underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate and in whom 12-months follow-up data were available

You may qualify if:

  • Clinical diagnosis of prostatic hyperplasia
  • underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate
  • months follow-up data were available

You may not qualify if:

  • previous diagnosis of urethral stricture, prostate carcinoma, and neurogenic bladder disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology, Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Jae-Seung Paick, doctor of philosophy

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2014

First Posted

February 27, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2014

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations