Impact of Bladder Underactivity on Treatment Outcomes of... | NCT02243540

Studies
Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy

NCT02243540

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Sep 18, 2014Estimated

Enrollment

1,828Estimated

Phase

Not provided

Conditions

Prostatic Hyperplasia

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

Apr 2014

Primary Completion Date

Sep 2014Estimated

Completion Date

Not provided

First Submitted Date

Sep 14, 2014

First Submission Date that Met QC Criteria

Sep 15, 2014

First Posted Date

Sep 18, 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 18, 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 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.

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

1,828Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

a previous diagnosis of urethral stricture
prostate or bladder carcinoma
neurogenic bladder disease
a previous history of urological 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 of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia refractory to medical treatment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jae-Seung Paick, M.D., Ph.D.	Contact	82-2-2072-2422	2422	jspaick@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Jae-Seung Paick, M.D., Ph.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

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