Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH
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|ClinicalTrials.gov Identifier: NCT01218672|
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : September 3, 2020
Last Update Posted : September 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Device: Photoselective Vaporization of the Prostate Device: Transurethral Resection of the Prostate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||291 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||December 2014|
Experimental: GreenLight XPS
Photoselective vaporization of the prostate using GreenLight XPS laser system.
Device: Photoselective Vaporization of the Prostate
GreenLight XPS laser console GreenLight XPS consists of a 532 nm laser console capable of achieving power outputs between 20W and 180W. Laser technology is used to vaporize tissue for debulking prostatic hyperplasia and improvement of lower urinary tract symptoms. The 532 nm wavelength is in the visible spectrum as green light and is strongly absorbed by oxyhemoglobin.
GreenLight XPS will be used in conjunction with the MoXy™ fiber. The fiber features a side firing mechanism delivering up to180W of 532 nm light to vaporize and coagulate the prostate tissue. The fiber is guided to the treatment site by the continuous flow cystoscope, consisting of an inner and outer sheath set, 30ْ forward oblique telescope and visual obturator.
Active Comparator: Transurethral Resection of the Prostate
Monopolar and bipolar Transuretheral resection of the prostate (TURP)
Device: Transurethral Resection of the Prostate
Monopolar and bipolar loop TURP Systems The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system that carry the CE mark may be used for the study.
- International Prostate Symptom Score (IPSS) [ Time Frame: 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).
- Maximum Urinary Flow Rate (Qmax) [ Time Frame: 6 months ]Qmax measured from a void of at least 150 ml in volume.
- Freedom From Complications [ Time Frame: 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.
- Prostate Volume [ Time Frame: 6 months ]Prostate volume measured via transrectal ultrasound
- Post Treatment Outcomes of PVP and TURP [ Time Frame: 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.
- Immediate Post Treatment Outcomes of PVP and TURP [ Time Frame: 3 weeks ]Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time
- Health Status of PVP and TURP [ Time Frame: 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).
- Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) [ Time Frame: 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).
- Subject Satisfaction of PVP and TURP [ Time Frame: 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.
- Rate of Retreatment of PVP and TURP [ Time Frame: 2 Years ]Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218672
|Principal Investigator:||Alexander Bachman, Prof. Dr. med.||University Hospital, Basel, Switzerland|
|Principal Investigator:||Andrew Thomas, MBBCh, FRCS||Princess of Wales Hospital, Bridgend Mid Glamorgan|