Benign Prostatic HyperplasiaNCT01218672
Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH
A study testing Photoselective Vaporization of the Prostate and Transurethral Resection of the Prostate in people with Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 29 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Photoselective Vaporization of the Prostate and Transurethral Resection of the Prostate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 29 sitesin 9 countries
- Study dates
- Apr 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided informed consent and agrees to attend all study visits
- Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
- Subject is willing to be randomized
- Subject is able to complete self-administered questionnaires
- Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate for either the PVP or the TURP procedure and may be randomized into either arm
- Subject is 40 to 80 years of age
Show all 11Show fewer
- Subject has an IPSS score greater than or equal to 12 measured at the baseline visit
- Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15ml/s (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 150ml, and the Qmax is less than 15ml/s it may be used for the inclusion/exclusion criteria)
- Subject has medical record documentation of a prostate volume of less than or equal to 100g by transrectal ultrasound (TRUS) (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is less than or equal to 100g, it may be used for the inclusion/exclusion criteria)
- Subject is classified as American Society of Anesthesiologists (ASA) I, II or III
- Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured less than or equal to 30 days prior to the date of surgery.
Who cannot join
- Subject has a life expectancy of less than 2 years
- Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless preapproved by the sponsor
- Subject has an active infection (eg, urinary tract infection or prostatitis)
- Subject has a diagnosis of, or has received treatment for, chronic prostatitis or chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis)
- Subject has been diagnosed with a urethral stricture or bladder neck contracture within the 180 days prior to the informed consent date
- Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within the 5 years prior to the informed consent date
Show all 22Show fewer
- Subject has a diagnosis of lichen sclerosus
- Subject has a neurogenic bladder or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries)
- Subject has a diagnosis of polyneuropathy (eg, diabetic)
- Subject has history of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis)
- Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad/device use
- Subject has a history of intermittent self catheterization
- Subject has been catheterized or has a PVR >400mls in the 14 days prior to the surgical procedure
- Subject has current diagnosis of bladder stones
- Subject has diagnosis of prostate cancer
- Subject has a history of CIS, TaGII, TaGIII or any T1 stage bladder cancer
- Subject has damage to external urinary sphincter
- Subject has a medical contraindication for undergoing either TURP or PVP surgery (eg, infection, coagulopathy or significant cardiac or other medical risk factors for surgery)
- Subject has a disorder of the coagulation cascade (eg, hemophilia) or disorders that affect platelet count or function (eg, Von Willebrand's disease) that would put the subject at risk for intraoperative or postoperative bleeding
- Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 days) except for low dose aspirin (eg, less than or equal to 100mg)
- Subject has had an acute myocardial infarction, open heart surgery or cardiac arrest less than 180 days prior to the date of informed consent
- Subject is immunocompromised (eg, organ transplant, leukemia)
Trial locations and contacts
29 sites in 9 countries.
29 sites in 9 countries
United Kingdom10 sites
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, Hampshire, RG24 9NA, UK
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, BN2 1EX UK
Mid Yorkshire NHS Trust Dewsbury & District Hospital
Dewsbury
Western General Hospital
Edinburgh, EH4 2XU
Frimley Park Hospital
Frimley, Camberley Surrey, GU16 7UJ- UK
Kent and Canterbury Hospital
Kent
Kings's College Hospital
London, SE5 9RS
Whipps Cross University Hospital
London
Princess of Wales Hospital
Mid Glamorgan, Wales UK, CF31 1RQ
Freeman Hospital
Newcastle
Germany9 sites
Campus Bejamin Franklin Hindenburgdamm
Berlin
UroForshungs GmbH, im St. hedwig Krankenhaus
Berlin
Krankenhaus Nordwest
Frankfurt
University Hospital of Heidelberg
Heidelberg, 69120
Hospital University of Jena
Jena
Universitatsklinikum Schleswig-Holstein, Campus Kiel
Kiel
Universitatsklinikum Leipzig
Leipzig
Universitatsklinikum Magdeburg
Magdeburg
Diakoniekrankenhaus Rotenburg (W.) gGmbH
Rotenburg (Wümme)
France2 sites
Nouvel Hopital Civil de Strasbourg
Strasbourg
CHU Bretonneau
Tours
Netherlands2 sites
ZGT Almelo
Almelo
RadBound University Njmegen Medical Centre
Nijmegen, 6500 HB Nijmegen
Spain2 sites
Hospital Iniversitario Fundacion Alcorcon
Madrid
Hospital de Manacor
Manacor
Italy1 site
Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital
Rome
About this study
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
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).
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Photoselective Vaporization of the Prostate, Transurethral Resection of the Prostate
- Keywords
- BPH, Benign Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photoselective Vaporization of the ProstateDevice
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.
Transurethral Resection of the ProstateDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| GreenLight XPS | Experimental | Photoselective vaporization of the prostate using GreenLight XPS laser system. Receives: Device: Photoselective Vaporization of the Prostate |
| Transurethral Resection of the Prostate | Active comparator | Monopolar and bipolar Transuretheral resection of the prostate (TURP) Receives: Device: Transurethral Resection of the Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (IPSS)
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).
Measured: 6 months
Secondary outcomes (9)
Maximum Urinary Flow Rate (Qmax)
Qmax measured from a void of at least 150 ml in volume.
Measured: 6 months
Freedom From Complications
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.
Measured: 180 days
Prostate Volume
Prostate volume measured via transrectal ultrasound
Measured: 6 months
Post Treatment Outcomes of PVP and TURP
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.
Measured: 3 weeks post treatment
Immediate Post Treatment Outcomes of PVP and TURP
Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time
Measured: 3 weeks
Health Status of PVP and TURP
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).
Measured: Baseline and 24-months
Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
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).
Measured: Baseline, 12-months, and 24-months
Subject Satisfaction of PVP and TURP
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.
Measured: 3-weeks, 3-months, 6-months, 12-months, and 24-months
Rate of Retreatment of PVP and TURP
Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startApr 2011
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Bachman, Prof. Dr. med., Principal investigator, University Hospital, Basel, SwitzerlandAndrew Thomas, MBBCh, FRCS, Principal investigator, Princess of Wales Hospital, Bridgend Mid Glamorgan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218672
- Sponsor's protocol ID
- PE1006
- Status last verified
- Jul 2020
- First submitted
- 8 Oct 2010
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.
PubMed 26283011Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.
PubMed 24331152
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01218672
- Acronym / sponsor ID
- PE1006
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH, Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GreenLight XPS | Experimental | Device: Photoselective Vaporization of the ProstatePhotoselective vaporization of the prostate using GreenLight XPS laser system. |
| Transurethral Resection of the Prostate | Active comparator | Device: Transurethral Resection of the ProstateMonopolar and bipolar Transuretheral resection of the prostate (TURP) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject has provided informed consent and agrees to attend all study visits
- Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction
- Subject is willing to be randomized
- Subject is able to complete self-administered questionnaires
- Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate for either the PVP or the TURP procedure and may be randomized into either arm
Key exclusion criteria (22 listed)
- Subject has a life expectancy of less than 2 years
- Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless preapproved by the sponsor
- Subject has an active infection (eg, urinary tract infection or prostatitis)
- Subject has a diagnosis of, or has received treatment for, chronic prostatitis or chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis)
- Subject has been diagnosed with a urethral stricture or bladder neck contracture within the 180 days prior to the informed consent date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photoselective Vaporization of the ProstateGreenLight 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. | Device | GreenLight XPS |
| Transurethral Resection of the ProstateMonopolar 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. | Device | Transurethral Resection of the Prostate |
Primary outcome
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).
9 secondary outcomes
Maximum Urinary Flow Rate (Qmax)
Time frame: 6 months
Freedom From Complications
Time frame: 180 days
Prostate Volume
Time frame: 6 months
Post Treatment Outcomes of PVP and TURP
Time frame: 3 weeks post treatment
Immediate Post Treatment Outcomes of PVP and TURP
Time frame: 3 weeks
Health Status of PVP and TURP
Time frame: Baseline and 24-months
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
Subject Satisfaction of PVP and TURP
Time frame: 3-weeks, 3-months, 6-months, 12-months, and 24-months
Rate of Retreatment of PVP and TURP
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26283011Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.
- Derived from this study: PubMed 24331152Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Bachman, Prof. Dr. med. principal investigator
University Hospital, Basel, Switzerland
Andrew Thomas, MBBCh, FRCS principal investigator
Princess of Wales Hospital, Bridgend Mid Glamorgan
29 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photoselective Vaporization of the Prostate and Transurethral Resection of the Prostate in people with Benign Prostatic Hyperplasia, run by Boston Scientific Corporation at 29 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom, Germany, France, Netherlands, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01218672, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2020.