BPH With Urinary ObstructionRezūm XLNCT03605745

Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL)

A study testing Prostatic Vapor Ablation in people with BPH With Urinary Obstruction and BPH, run by Boston Scientific Corporation at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and ≤150 cm3. Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: BPH With Urinary Obstruction, BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
What is being tested?: Prostatic Vapor Ablation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 10 sitesin 2 countries
Study dates: 19 Jun 2018to 11 Aug 2020
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 50 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male subjects ≥ 50 years of age who have symptomatic BPH.
International Prostate Symptom Score (IPSS) score ≥ 13.
Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml.
Post-void residual (PVR) ≤300 ml.
Prostate volume >80 cm3 to ≤150 cm3

Who cannot join

Urology:
Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate.
Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery.
Verified acute bacterial prostatitis within last 12 months documented by culture.
Active or history of epididymitis within the past 3 months.
Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device.

Show all 56Show fewer

Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months, provided that stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible.
Subject interested in maintaining fertility.
Use of the following medications where the dose is not stable (stable dose defined as the same medication and dose in the last three months):
Beta-blockers;
Anticonvulsants;
Antispasmodics;
Antihistamines;
Alpha blockers for BPH and anticholinergics or cholinergics;
Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia));
Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart));
Estrogen, drug-producing androgen suppression, or anabolic steroids;
PD5 Inhibitors (e.g., Viagra, Levitra or Cialis)
Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter 6 months prior to baseline. A provoked episode now resolved is still admissible
Evidence of atonic neurogenic bladder evaluated by a baseline urodynamic assessment.
Visible hematuria with subject urine sample without a known contributing factor.
Presence of a penile implant or stent(s) in the urethra or prostate
Active urinary tract infection by culture within 7 days of treatment or two documented independent urinary tract infections of any type in the past 6 months.
Gastroenterology:
Previous pelvic irradiation or radical pelvic surgery.
Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.
Nephrology:
Compromised renal function defined as serum creatinine > 2.0 mg/dl.
Hydronephrosis (Grade 2 or higher).
Oncology:
Prostate cancer testing:
If PSA is > 2.5 ng/ml and ≤ 10 ng/ml with free PSA <25%, prostate cancer for the subject must be/had been ruled out through a negative biopsy prior to enrollment
Males 50-59 years - PSA is >2.5 ng/ml and ≤10 ng/ml with free PSA <25%,
Males 60+ years - PSA is >4 ng/ml and ≤10 ng/ml, with free PSA <25%
History of confirmed malignancy or cancer of the prostate or bladder; however, high grade prostatic intraepithelial "PIN" is acceptable.
History of cancer in non-genitourinary system that is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of enrollment.
Cardiology:
History of clinically significant congestive heart failure (i.e., NYHA Class III and IV).
Cardiac arrhythmias that are not controlled by medication and/or medical device.
An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
Pulmonology:
History of significant respiratory disease where hospitalization for the disease is required.
Hematology:
Diagnosed or suspected bleeding disorder, or coagulopathies.
Use of antiplatelet or anticoagulant medication except low dose aspirin (<100mg/day) within 10 days prior to treatment.
Endocrinology:
History of diabetes not controlled by a stable dose of medication over the past three months, provided that patients with a hemoglobin A1c <8.0% are allowed.
Immunology:
History of immunosuppressive conditions (e.g., AIDS, post-transplant).
Neurology:
Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires.
Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function (< 25% of accepted and established nomograms).
General:
Currently enrolled in any other pre-approval investigational study in the US (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.).
Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
Inability to provide a legally effective "Informed Consent Form" and/or comply with all the required follow-up requirements.

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States9 sites

Houston Metro Urology
Houston, Texas, 77030
First Urology, PSC
Jeffersonville, Indiana, 47130
University of Kansas Medical Center
Kansas City, Kansas, 66160
Adult & Pediatric Urology, P.C.
Omaha, Nebraska, 68114
Urology San Antonio
San Antonio, Texas, 78229
Arizona Urology Specialists
Scottsdale, Arizona, 85258
Jersey Urology Group
Somers Point, New Jersey, 08244
Pinellas Urology, LLC
St. Petersburg, Florida, 33710
Chesapeake Urology Associates, LLC
Towson, Maryland, 21204

Other trials in United States

Australia1 site

Sydney Adventist Hospital/University of Sydney
Wahroonga, New South Wales, 2076

Other trials in Australia

About this study

Official title: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezūm XL)

Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and ≤150 cm3.

Read the detailed description

A prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and ≤150 cm3.

Conditions: BPH With Urinary Obstruction, BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Being tested: Prostatic Vapor Ablation
Keywords: BPH, Minimally Invasive, Water Vapor Therapy, Rezum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prostatic Vapor AblationDevice
Also called Rezum, Water Vapor Ablation
Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.

Study groups in NCT03605745
Study group	Role	What they receive
Treatment	Experimental	Prostatic Vapor Ablation with Rezum Receives: Device: Prostatic Vapor Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) > 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Measured: 6 Months
Number of Participants With Post Procedure Device Related Serious Complications
Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.
Measured: 6 Months

Secondary outcomes (2)

Number of Subjects With Device-related Retention Catheterizations
This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
Measured: 6 Month
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up
The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Measured: Baseline, 6 weeks, 3 months, 6 months, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 201811 Aug 2020

First posted30 Jul 2018
Study start19 Jun 2018
Primary completion25 Jun 2020
Study completion11 Aug 2020

Why it stopped: Sponsor decided to terminate the study due to business reasons

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.
Other trials for BPH With Urinary ObstructionStudies 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: Not applicable
Intervention model: Single group
Model description: This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03605745
Sponsor's protocol ID: 3034-001
Acronym: Rezūm XL
Status last verified: Jul 2021
First submitted: 23 Jul 2018
Last updated: 10 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All BPH With Urinary Obstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Single Arm Study for the Treatment of BPH in Large Prostates (Rezūm XL)
ClinicalTrials.gov ID: NCT03605745
Acronym / sponsor ID: Rezūm XL / 3034-001
Conditions: BPH With Urinary Obstruction, BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
Keywords: BPH, Minimally Invasive, Water Vapor Therapy, Rezum
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decided to terminate the study due to business reasons
Enrolment: 47 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 19 Jun 2018 (actual)
Primary completion: 25 Jun 2020 (actual)
Study completion: 11 Aug 2020 (actual)
First posted: 30 Jul 2018 (actual)
Results: Posted 10 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and ≤150 cm3.

Detailed description

A prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes >80cm3 and ≤150 cm3.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This study is a prospective, non-randomized clinical trial of subjects with benign prostatic hypertrophy (BPH).

Arm	Type	Receives
Treatment	Experimental	Device: Prostatic Vapor AblationProstatic Vapor Ablation with Rezum

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male subjects ≥ 50 years of age who have symptomatic BPH.
International Prostate Symptom Score (IPSS) score ≥ 13.
Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 12 ml/sec with minimum voided volume of ≥ 125 ml.
Post-void residual (PVR) ≤300 ml.
Prostate volume >80 cm3 to ≤150 cm3

Key exclusion criteria (56 listed)

Any prior invasive prostate intervention (e.g., "Radiofrequency" thermotherapy, balloon, microwave thermotherapy, "Prostatic Urethral Lift", "Transurethral Resection", or laser) or other surgical interventions of the prostate.
Undergone a prostate biopsy within 60 days prior to the scheduled treatment date or has an imminent need for surgery.
Verified acute bacterial prostatitis within last 12 months documented by culture.
Active or history of epididymitis within the past 3 months.
Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the Rezūm device.

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
Prostatic Vapor AblationAlso: Rezum, Water Vapor AblationRezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate. Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response.	Device	Treatment

Primary outcome

Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)
Time frame: 6 Months
The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) > 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Number of Participants With Post Procedure Device Related Serious Complications
Time frame: 6 Months
Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.

2 secondary outcomes

Number of Subjects With Device-related Retention Catheterizations
Time frame: 6 Month
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-up
Time frame: Baseline, 6 weeks, 3 months, 6 months, 1 year

Results and safety

Results posted to the registry on 10 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	47	0

Primary outcome: Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)

Time frame: 6 Months. Count of participants. Unit: Participants

Measure	Treatment n = 47
Value	39

Population analysed: All subjects enrolled were included in the analysis.

Primary outcome: Number of Participants With Post Procedure Device Related Serious Complications

Time frame: 6 Months. Count of participants. Unit: Participants

Measure	Treatment n = 47
Value	0

Population analysed: All subjects enrolled were included in the analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	4 of 47 (8.5%)	41 of 47 (87.2%)	0 of 47

Limitations and caveats (from the sponsor): The study was terminated by the sponsor for business reasons. As a result there is no patient data presented for the 12 month, 2 year and 3 year follow up visits as they did not occur per termination.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for BPH With Urinary Obstruction

Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
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Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
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Recruiting
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Active, not recruiting
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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.

Henry Woo, MD principal investigator

Sydney Adventist Hospital

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prostatic Vapor Ablation in people with BPH With Urinary Obstruction and BPH, run by Boston Scientific Corporation at 10 sites in 2 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 5 inclusion and 56 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: stopped early, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Australia. 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 10 Aug 2021). 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?

Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS) (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 NCT03605745.

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 10 Aug 2021.