KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Tra... | NCT02011308

Studies
KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)

NCT02011308

Sponsor

University of Helsinki

Status

Completed

Last Update Posted

Nov 14, 2017Actual

Enrollment

217Actual

Phase

Not Applicable

Conditions

BPH (Benign Prostatic Hyperplasia)

Interventions

Green light Laser
Transurethral Resection of the Prostate (TURP)

Countries

Finland

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Feb 21, 2012

First Submission Date that Met QC Criteria

Dec 10, 2013

First Posted Date

Dec 13, 2013Estimated

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

Nov 13, 2017

Last Update Posted Date

Nov 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hannu Koistinen, Urologist, University of HelsinkiPrincipal Investigator

Lead Sponsor

University of HelsinkiOTHER

Collaborators

Name	Class
University of Turku	OTHER
Tampere University	OTHER
South Ostrobothnia Health Care District	OTHER
Oulu University Hospital

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 purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to TUR-P.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

217Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Green Light Laser	Active Comparator		Device: Green light Laser Device: Transurethral Resection of the Prostate (TURP)
TURP	Active Comparator	Transurethral Resection of the Prostate	Device: Green light Laser Device: Transurethral Resection of the Prostate (TURP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Green light Laser	Device	Laser vs TURP	Green Light Laser TURP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IPSS (International Prostate Symptom Score)	symptom	12 months

Secondary Outcomes

Measure	Description	Time Frame
DAN-PSS (Danish Prostate Symptom Score)	symptom	3, 6 and 12 months
Maximum flow rate (Qmax)		3, 6 and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men undergoing surgery for BPH

Exclusion Criteria:

Previous prostate surgery
Carcinoma of the prostate
Neurogenic bladder
Bladder carcinoma

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hannu T Koistinen, M.D.	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Hospital		Helsinki		00350	Finland

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

Intervention Browse Module

MeSH Terms

ID	Term
D020728	Transurethral Resection of Prostate

Ancestor Terms

ID	Term
D011468	Prostatectomy
D013521	Urologic Surgical Procedures, Male
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided