NCT02241902

Brief Summary

The aim of this study was to identify serial changes in the incidence of postoperative pyuria after the Photoselective Vaporization of the Prostate (PVP), to determine whether the presence of postoperative pyuria could be correlated with surgical outcomes after surgery and to identify predicting factors that influence on persistent pyuria after the PVP.

Trial Health

55
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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-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

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

September 13, 2014

Last Update Submit

September 15, 2014

Conditions

Prostatic HyperplasiaPyuria

Outcome Measures

Primary Outcomes (1)

  • Change in the subtotal storage symptoms score of the International Prostate Symptom Score (IPSS)

    1-week, and 1-, 3- and 6-months after the surgery

Study Arms (2)

No pyuria

Persistent pyuria

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 (PVP) using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment

You may qualify if:

  • men who underwent photoselective vaporization (PVP) using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment
  • sterile urine on urinalysis and urine culture before surgery
  • absence of indwelling urethral catheter before surgery

You may not qualify if:

  • previous diagnosis of prostate carcinoma or bladder cancer
  • co-existence of urinary stone
  • any antibiotic treatment within 2-weeks before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongguk University ilsan Hospital

Goyang-si, Gyeonggi-do, 410-773, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic HyperplasiaPyuria

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrinary Tract InfectionsInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Min Chul Cho, M.D., Ph.D.

    DongGuk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Chul Cho, M.D., Ph.D.

CONTACT

82-31-961-7456cmc1206@empal.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 16, 2014

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

KR(1)