The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). The study requires use of the CE marked GreenLight XPS* Laser System (GreenLight…
ID
Source
Brief title
Condition
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate that BPH symptoms after PVP are not worse when compared to TURP
at 6 months post procedure measured via international prostate symptom score
(IPSS) for the treatment of BPH.
Secondary outcome
1. To compare the complication-free rate between PVP and TURP
2. To compare prostate volume post treatment for PVP and TURP
3. To compare functional status of PVP and TURP via maximum urinary flow rate
(Qmax)
4. To compare immediate post intervention outcomes of PVP and TURP
• Short Form Health Survey (SF-36) Acute at 3-week visit
• Length of stay
5. To compare health status of PVP and TURP
• International prostate symptom score (IPSS)
• BPH Impact Index (BII)
• Overactive Bladder Questionnaire (OABq)
• SF-36 Acute
• EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D)
6. To compare tolerability of PVP and TURP
• International Index of Erectile Function (IIEF)
• ICIQ-SF International Consultation on Incontinence Questionnaire Short Form
7. To compare subject satisfaction of PVP and TURP
• Subject satisfaction questionnaire
8. To compare rate of retreatment of PVP and TURP
Background summary
Limited published literature and randomized data are available to demonstrate
the differences between PVP and TURP and suggest additional randomized studies
comparing PVP and TURP are needed to demonstrate efficacy, safety and health
economic outcomes.1,2 This study is designed to understand these differences
and the impact to patient-reported outcomes, health economics and overall
safety.
Study objective
The study will compare procedural and post procedural outcomes for
photoselective vaporization of the prostate (PVP) and transurethral resection
of the prostate (TURP). The study requires use of the CE marked GreenLight XPS*
Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP
system for the treatment of benign prostatic hyperplasia (BPH). The purpose of
the study is to demonstrate that PVP is not inferior to TURP.
Study design
This is a randomized, prospective, multicenter study design to be conducted at
up to 25 centers in Europe. The primary endpoint will be measured at 6 months
and subjects will be followed out to 2 years to collect long-term clinical
data.
Approximately 252 subjects will be enrolled in order to achieve a minimum of
188 subjects with 6 month follow-up IPSS data. A conservative attrition rate of
25% was used to account for subjects enrolled and not receiving treatment or
who are missing 6-month follow-up IPSS data. The goal is for each study center
is to enroll 1 subject per month with a maximum of 38 subjects enrolled per
center; additional subjects may only be enrolled with written preapproval from
the sponsor.
Individual subjects will be exited upon completion of the 2-year follow-up
visit. The total study duration is estimated to be 4 years from time of first
enrollment through final subject completing a 2-year follow-up visit.
Intervention
Subjects will be randomized to be treated either receiving PVP or TURP therapy.
They will be followed for the duration of 2 years
Study burden and risks
Both PVP and TURP procedures carry the CE mark and have similar risk profiles.
There are no additional risks associated with participation in the study. For
risks associated with surgical treatment of BPH please see the protocol,
chapter 10.2
10700 Bren Road West
Minnetonka MN 55343
US
10700 Bren Road West
Minnetonka MN 55343
US
Listed location countries
Age
Inclusion criteria
The patient is candidate for desobstructive surgery of the prostate due to symptomatic BPH by TURP or PVP
The IPSS score is > 12
Qmax < 15 ml/sec
Prostate Volume < 100 cc
Exclusion criteria
Life expectancy < 2 years
Active Urinary Tract Infection
Prostatitis
Neurogenic bladder
Diagnosis prostate carcinoma
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34977.091.10 |