A prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate with the GreenLight XPS Laser System and Transurethral resection of the Prostate for Treatment of benign Prostatis Hyperplasia

A prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate with the GreenLight XPS Laser System and Transurethral resection of the Prostate for Treatment of benign Prostatis Hyperplasia - GreenLight XPS vs TURP Randomized Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36344

Enrollment

Registered

2011-05-18

Start date

2011-09-05

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia

Interventions

Subjects will be randomized to be treated either receiving PVP or TURP therapy. They will be followed for the duration of 2 years

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Life expectancy

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)