Recruitment

Recruitment Status
Completed
Estimated Enrollment
195

Inclusion Criterias

Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
International Prostate Symptom Score (IPSS) score ≥ 13.
Post-void residual (PVR) ≤250 ml.
...
Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
International Prostate Symptom Score (IPSS) score ≥ 13.
Post-void residual (PVR) ≤250 ml.
Prostate volume > 30 and ≤ 80 gm.
Male subjects > 50 years of age who have symptomatic BPH.

Exclusion Criterias

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).
An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
Visible hematuria with subject urine sample without a known contributing factor.
...
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).
An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
Visible hematuria with subject urine sample without a known contributing factor.
History of immunosuppressive conditions (e.g., AIDS, post-transplant).
Diagnosed with active Lyme Disease (borreliosis).
History of clinically significant congestive heart failure (i.e. NYHA Class III and IV).
Diagnosed or suspected bleeding disorder, or coagulopathies.
Use of estrogen, drug-producing androgen suppression, or anabolic steroids within 3 months of baseline assessment.
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.
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.
Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.
Cardiac arrhythmias that are not controlled by medication or medical device.
Use of Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) within 3 months of baseline assessment.
Previous pelvic irradiation or radical pelvic surgery.
Compromised renal function defined as serum creatinine > 2.0 mg/dl.
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.
Subject interested in maintaining fertility.
Post-void residual (PVR) > 250 ml.
Active or history of epididymitis within the past 3 months.
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.
Presence of a penile implant or stent(s) in the urethra or prostate.
Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
History of significant respiratory disease where hospitalization for the disease is required.
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.
Use of antihistamines within 1 week of treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes).
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.
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.
Use of daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) within 4 weeks of baseline assessment.
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.
Use of a dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) within 6 months of baseline assessment.
Use of antiplatelet or anticoagulant medication except low dose aspirin (≤81 mg/day) within 10 days prior to treatment.
Verified bacterial prostatitis within last 12 months documented by culture or non-bacterial prostatitis within the last 5 years.
Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate.
History of confirmed malignancy or cancer of prostate or bladder, however, high grade PIN is acceptable.
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 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.
Neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function.
Has undergone prostate biopsy within 60 days prior to treatment date or has an imminent need for surgery.
Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the device.

Summary

Conditions
  • Benign Prostatic Hyperplasia
  • Lower Urinary Tract Symptom
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 50 years and 125 years
Gender
Only males

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 Con...

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.

Inclusion Criterias

Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
International Prostate Symptom Score (IPSS) score ≥ 13.
Post-void residual (PVR) ≤250 ml.
...
Peak urinary flow rate (Qmax): ≥ 5ml/sec to ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml.
International Prostate Symptom Score (IPSS) score ≥ 13.
Post-void residual (PVR) ≤250 ml.
Prostate volume > 30 and ≤ 80 gm.
Male subjects > 50 years of age who have symptomatic BPH.

Exclusion Criterias

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).
An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
Visible hematuria with subject urine sample without a known contributing factor.
...
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).
An episode of unstable angina pectoris, a myocardial infarction, transient ischemic attack, or a cerebrovascular accident within the past six months.
Visible hematuria with subject urine sample without a known contributing factor.
History of immunosuppressive conditions (e.g., AIDS, post-transplant).
Diagnosed with active Lyme Disease (borreliosis).
History of clinically significant congestive heart failure (i.e. NYHA Class III and IV).
Diagnosed or suspected bleeding disorder, or coagulopathies.
Use of estrogen, drug-producing androgen suppression, or anabolic steroids within 3 months of baseline assessment.
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.
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.
Previous rectal surgery (other than hemorrhoidectomy) or known history of rectal disease.
Cardiac arrhythmias that are not controlled by medication or medical device.
Use of Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) within 3 months of baseline assessment.
Previous pelvic irradiation or radical pelvic surgery.
Compromised renal function defined as serum creatinine > 2.0 mg/dl.
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.
Subject interested in maintaining fertility.
Post-void residual (PVR) > 250 ml.
Active or history of epididymitis within the past 3 months.
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.
Presence of a penile implant or stent(s) in the urethra or prostate.
Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study.
History of significant respiratory disease where hospitalization for the disease is required.
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.
Use of antihistamines within 1 week of treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes).
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.
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.
Use of daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) within 4 weeks of baseline assessment.
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.
Use of a dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) within 6 months of baseline assessment.
Use of antiplatelet or anticoagulant medication except low dose aspirin (≤81 mg/day) within 10 days prior to treatment.
Verified bacterial prostatitis within last 12 months documented by culture or non-bacterial prostatitis within the last 5 years.
Any prior invasive prostate intervention (e.g., radio frequency (RF) ablation, balloon, microwave, or laser) or other surgical interventions of the prostate.
History of confirmed malignancy or cancer of prostate or bladder, however, high grade PIN is acceptable.
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 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.
Neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function.
Has undergone prostate biopsy within 60 days prior to treatment date or has an imminent need for surgery.
Urethral strictures, bladder neck contracture, unusual anatomy or muscle spasms that would prevent the introduction and use of the device.

Locations

Tucson, Arizona, 85704
Myrtle Beach, South Carolina, 29572
Carrollton, Texas, 75010
Towson, Maryland, 21204
Cleveland, Ohio, 44195
...
Tucson, Arizona, 85704
Myrtle Beach, South Carolina, 29572
Carrollton, Texas, 75010
Towson, Maryland, 21204
Cleveland, Ohio, 44195
Cincinnati, Ohio, 45212
Dallas, Texas, 75390
San Antonio, Texas, 78229
Aventura, Florida, 33180
Springfield, Illinois, 62794
Rochester, Minnesota, 55905
Salt Lake City, Utah, 84124
New York, New York, 10016
Denver, Colorado, 80113
Woodbury, Minnesota, 55125

Tracking Information

NCT #
NCT01912339
Collaborators
Not Provided
Investigators
  • Principal Investigator: Claus Roehrborn, MD UT Southwestern Principal Investigator: Kevin McVary, MD Southern Illinois University
  • Claus Roehrborn, MD UT Southwestern Principal Investigator: Kevin McVary, MD Southern Illinois University