Impact of Postoperative Pyuria on Treatment Outcomes Afte... | NCT02241902

Studies
Impact of Postoperative Pyuria on Treatment Outcomes After PVP

NCT02241902

Sponsor

DongGuk University

Status

Unknown status

Last Update Posted

Sep 16, 2014Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Prostatic Hyperplasia
Pyuria

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Mar 2015Estimated

Completion Date

Not provided

First Submitted Date

Sep 13, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2014

Last Update Posted Date

Sep 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Chul Cho, M.D., Ph.D.	Contact	82-31-961-7456	7456	cmc1206@empal.com

Overall Officials

Name	Affiliation	Role
Min Chul Cho, M.D., Ph.D.	DongGuk University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongguk University ilsan Hospital	Recruiting	Goyang-si	Gyeonggi-do	410-773	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia
D011776	Pyuria

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
No pyuria
Persistent pyuria