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Benign Prostatic HyperplasiaREZUMNCT01912339

Safety and Efficacy Study for the Treatment of BPH (Enlarged Prostate)

A study testing Rezum System and Rigid Cystoscopy in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptom, run by Boston Scientific Corporation at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH). Read more about this study

Who is it for?
Ages 50 years and older, men only
What is being tested?
Rezum System and Rigid Cystoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
15 sitesUnited States
Study dates
Jul 2013to 17 Oct 2016
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 ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
  • Post-void residual (PVR) ≤250 ml.
  • Prostate volume > 30 and ≤ 80 gm.

Who cannot join

  • History of clinically significant congestive heart failure (i.e. NYHA Class III and IV).
  • History of diabetes not controlled by a stable dose of medication over the past three months. Patients with a Hemoglobin A1c that is <8.0% are allowed.
  • History of significant respiratory disease where hospitalization for the disease is required.
  • History of immunosuppressive conditions (e.g., AIDS, post-transplant).
  • Cardiac arrhythmias that are not controlled by medication or medical device.
  • An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
Show all 41Show fewer
  • Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
  • Presence of a penile implant or stent(s) in the urethra or prostate.
  • Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate.
  • Currently enrolled in any other pre-approval investigational study in the USA (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.)).
  • History of confirmed malignancy or cancer of prostate or bladder, however, high grade 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 randomization.
  • Previous pelvic irradiation or radical pelvic surgery.
  • Diagnosed with active Lyme Disease (borreliosis).
  • PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. 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.
  • Has undergone prostate biopsy within 60 days prior to treatment date or has an imminent need for surgery.
  • Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.
  • 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.
  • Verified bacterial prostatitis within last 12 months documented by culture or non-bacterial prostatitis within the last 5 years.
  • Active or history of epididymitis within the past 3 months.
  • Neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function.
  • 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.
  • Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the device.
  • Diagnosed bladder, urethral or ureteral stones or active stone passage in the past 6 months. Stones that are known to be in the kidney and have been stable for a period exceeding 3 months are permissible.
  • Post-void residual (PVR) > 250 ml.
  • Diagnosed or suspected bleeding disorder, or coagulopathies.
  • Use of antiplatelet or anticoagulant medication except low dose aspirin (≤81 mg/day) within 10 days prior to treatment.
  • Visible hematuria with subject urine sample without a known contributing factor.
  • Subject interested in maintaining fertility.
  • Use of beta-blockers, anticonvulsants, and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months).
  • At the time of baseline assessment, in the absence of a qualifying exception, subjects who are using or have used the following medications, and are unable or unwilling to discontinue using these medications for the prescribed washout period:
  • Use of antihistamines within 1 week of treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes).
  • Use of the alpha blockers for BPH and anticholinergics or cholinergics (except for topical anti cholinergic eye drops), or within 4 weeks of baseline assessment.
  • Use of Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) within 3 months of baseline assessment.
  • Use of a dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) within 6 months of baseline assessment.
  • Use of estrogen, drug-producing androgen suppression, or anabolic steroids within 3 months of baseline assessment.
  • Use of daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) within 4 weeks of baseline assessment.
  • Subjects who have had an incidence of spontaneous urinary retention either treated with indwelling transurethral catheter or suprapubic catheter six months prior to baseline. A provoked episode now resolved is still admissible.
  • Compromised renal function defined as serum creatinine > 2.0 mg/dl.
  • Inability to provide a legally effective Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Texas Urology

    Carrollton, Texas, 75010

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • UT Southwestern

    Dallas, Texas, 75390

  • Urology Associates of Denver

    Denver, Colorado, 80113

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Manhattan Medical Research

    New York, New York, 10016

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Urology of San Antonio

    San Antonio, Texas, 78229

  • Southern Illinois University

    Springfield, Illinois, 62794

  • Chesapeake Urology

    Towson, Maryland, 21204

  • Arizona Institute of Urology

    Tucson, Arizona, 85704

  • Metro Urology

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: Minimally Invasive Prostatic Vapor Ablation - Multicenter, Controlled Study for the Treatment of BPH (Rezūm II)

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Read the detailed description

This study is a prospective, controlled, randomized single blind clinical trial of subjects with benign prostatic hyperplasia, which will allow for an interim analysis for sample size adjustment. Subjects first will be randomized in a 2:1 proportion in favor of the Treatment arm. Subjects in the Control arm will be allowed to crossover to have the Rezūm treatment after the 3-month follow-up examination.

Being tested
Rezum System, Rigid Cystoscopy
Keywords
Hyperplasia, Retention, Prostate
Medical subject headings
Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Hyperplasia

What participants receive

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

  • Rezum SystemDevice

    The Rezūm System uses sterile water vapor (steam) to treat BPH by delivering targeted, controlled doses of stored thermal energy directly to the transition zone of the prostate gland.

    A narrow sheath, similar in shape and size to a cystoscope, is inserted transurethrally and positioned within the prostatic urethra between the bladder neck and the verumontanum.

    A thin needle is deployed through the urethra into the transition zone, and a very short (8-10 second) treatment of water vapor is delivered directly into the hyperplastic tissue and immediately disperses through the tissue interstices.

    Upon contact with the tissue, the vapor condenses, or phase shifts, into its liquid state, releasing the stored thermal energy contained within the vapor. This thermal energy is released directly against the walls of the tissue cells within the treatment zone, gently and immediately denaturing the cell membranes, thereby causing instantaneous cell death.

  • Rigid CystoscopyProcedure or surgery

    Also called Cystoscopy

    Endoscopy of the urinary bladder via the urethra.

Study groups in NCT01912339
Study groupRoleWhat they receive
TreatmentExperimentalTreatment: Rezūm System
Receives: Device: Rezum System
ControlOtherControl: Rigid Cystoscopy
Receives: Procedure: Rigid Cystoscopy

What is being measured

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

  1. Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up

    Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total score, summed across the seven items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms).

    Measured: 3 Month Follow-up Visit

  2. Safety: Device Related Serious Complications

    This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months.

    Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract. Twelve percent was a pre-specified performance goal for the safety endpoint.

    Measured: 3 Months

Secondary outcomes (3)

  1. Responders at 3 Months

    Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 3 months compared to baseline.

    Measured: 3 Months

  2. Responders at 6 Months

    Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 6 months compared to baseline.

    Measured: 6 Months

  3. Responders at 12 Months

    Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 12 months compared to baseline.

    Measured: 12 Months

Timeline

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

  1. First posted31 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMar 2015
  4. Study completion17 Oct 2016

Resources

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
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01912339
Sponsor's protocol ID
2105-001
Acronym
REZUM
Status last verified
Apr 2020
First submitted
26 Jul 2013
Last updated
13 Apr 2020
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Rezum System and Rigid Cystoscopy in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptom, run by Boston Scientific Corporation at 15 sites in United States.

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 41 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 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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 15 May 2017). 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?

Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up (time frame: 3 Month Follow-up Visit). 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 NCT01912339.

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 13 Apr 2020.

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