Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH

Not Applicable

Completed

Conditions: Benign Prostatic Hyperplasia

Registration Number: NCT01218672

Lead Sponsor: Boston Scientific Corporation

Brief Summary: The study compares procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. 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).

Detailed Description: The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 291

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS)	6 months	The IPSS is a patient-administered 7-question instrument used to classify severity of benign prostatic hyperplasia symptoms (BPH). Total scores can range from 0 to 35 (asymptomatic to very symptomatic).

Secondary Outcome Measures

Name	Time	Method
Prostate Volume	6 months	Prostate volume measured via transrectal ultrasound
Freedom From Complications	180 days	A complication is defined as a device or procedure-related adverse event meeting at least 1 of the following criteria: Perforation of tissue or a physiologic structure; Required a prolonged or secondary hospitalization; Required surgical or invasive intervention (e.g., breaking of the skin) and excluding urinary catheterization for transient retention lasting less than 7 days and/or IV medications related to anesthesia.
Immediate Post Treatment Outcomes of PVP and TURP	3 weeks	Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time
Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)	Baseline, 12-months, and 24-months	The International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) instruments will be collected at baseline and the follow-up visits. The IIEF-5 is a self-administered 5 question instrument that assesses the relevant domains of male sexual function such as erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction with a total possible score of 5-25 (higher score is better). The ICIQ-SFis a self-administered 4-question tool designed for the assessment and quantification of incontinence and its impact on quality of life during the previous 4 weeks with a total score of 0-21 (higher score is worse).
Maximum Urinary Flow Rate (Qmax)	6 months	Qmax measured from a void of at least 150 ml in volume.
Post Treatment Outcomes of PVP and TURP	3 weeks post treatment	Short Form Health Survey (SF-36 Acute) collected at 3-week visit. The SF-36 is a multi-purpose, short-form, health survey of functional health and well-being scores in a three-section format: Utility Index (score = 0-1 with higher score being better); Physical Component Summary (PCS) comprising of physical functioning, role-physical, bodily pain, and overall general health; Mental Component Summary (MCS) comprising of vitality, social functioning, role-emotional, and mental health. Each component in the PCS and MCS sections have a score of 1-100 with the higher score being better. The acute version uses a 1-week recall period.
Health Status of PVP and TURP	Baseline and 24-months	The IPSS, OABq, SF-36 Health Summary and EQ-5D instruments will be scored. IPSS classifies voiding symptoms with scores from 0-35 (asymptomatic to very symptomatic). The OABq captures overactive bladder symptom bother with scores from 0-100 (lower score is better). The SF-36 is a health survey with scores from 1-100 (higher score is better). EQ-5D assesses health status across a range of conditions and treatments with a score of 0-1 (higher score is better).
Rate of Retreatment of PVP and TURP	2 Years	Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required
Subject Satisfaction of PVP and TURP	3-weeks, 3-months, 6-months, 12-months, and 24-months	Subject responses to satisfaction with treatment as collected on follow-up visits. Data presented below indicates responses from subjects that would go through study treatment again at each of the defined follow-up visits.

Trial Locations

Locations (29): Krankenhaus der Barmherzigen Schwestern Linz
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Linz, Austria
AZ Maria Middelares Gent
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Gent, Belgium
Nouvel Hopital Civil de Strasbourg
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Strasbourg Cedex, France
CHU Bretonneau
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Tours Cedex, France
Campus Bejamin Franklin Hindenburgdamm
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Berlin, Germany
UroForshungs GmbH, im St. hedwig Krankenhaus
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Berlin, Germany
Krankenhaus Nordwest
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Frankfurt, Germany
University Hospital of Heidelberg
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Heidelberg, Germany
Hospital University of Jena
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Jena, Germany
Universitatsklinikum Schleswig-Holstein, Campus Kiel
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Kiel, Germany
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Krankenhaus der Barmherzigen Schwestern Linz
🇦🇹Linz, Austria