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Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).
Subjects with BPH symptoms were treated with the Rezum device with a range of thermal energies (as measured by calorie output) to optimize the setting for maximum lesion size with minimal intra and post-procedure discomfort. Lesion size and ablated tissue resorption rate was followed post-procedure at 1 week, 1 month, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezum Treatment | Experimental | Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezum System | Device | The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Prostate Symptom Score | International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. The IPSS is a validated questionnaire used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). Scoring ranges from 0 to 35 with overall scores of 0-7 correlated to mildly symptomatic, 8-19 correlated to moderately symptomatic and 20-35 correlated to severely symptomatic. A reduction in score from baseline corresponds to improved outcome post procedure. | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Intra-procedural and Post-procedural Pain | Intra-procedural and post-procedural pain for each subject was assessed using the Wong Baker Pain Rating scale (0-10 with 0 indicating no pain and 10 indicating worst pain imaginable). Each subject selected the response on the pain scale that he felt best represented his pain level. Unless otherwise noted, the subjects were not given pain medications or anesthesia. All subjects were given an anti-anxiety medication plus a Non-Steroidal Anti-Inflammatory Drug (NSAID) pre-procedure. |
Inclusion Criteria:
Exclusion Criteria:
History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
Presence of a penile implant.
Any prior minimally invasive intervention (e.g. TUNA,Laser, Microwave) or surgical intervention for the symptoms of BPH.
Currently enrolled in another clinical trial.
Confirmed or suspected malignancy of prostate or bladder.
Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
Previous pelvic irradiation or radical pelvic surgery.
Documented active urinary tract infection by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen).
Neurogenic bladder or sphincter abnormalities.
Urethral strictures, bladder neck contracture or muscle spasms.
Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
Subjects who are interested in maintaining fertility.
Use of concomitant (or recent) medications to include the following:
Subject is unable or unwilling to go through a "washout" period for the above medications prior to treatment.
Subject has chronic urinary retention.
Significant urge incontinence.
Poor detrusor muscle function.
Neurological disorders which might affect bladder or sphincter function.
Bladder stones.
Renal impairment.
In the opinion of the Principal Investigator, subject will not be able to adequately tolerate a rigid cystoscopy-type procedure.
Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.
Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
Biopsy of the prostate within 30 days prior to the Rezūm procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Canela | La Romana | Dominican Republic |
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This single arm, single center interventional study recruited subjects who met inclusion/exclusion criteria and consented to participate. Subjects on BPH medication underwent a washout period prior to treatment. Subjects who successfully completed the washout period and still met the inclusion/exclusion criteria were enrolled in the study. Subjects were considered officially enrolled only if treatment with the NxThera Rezūm System was attempted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rezum Treatment | Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rezum Treatment | Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in International Prostate Symptom Score | International Prostate Symptom Score (IPSS) scores were recorded at Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, then annually to 5 years. The mean change in IPSS was calculated. The IPSS is a validated questionnaire used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of benign prostatic hyperplasia (BPH). Scoring ranges from 0 to 35 with overall scores of 0-7 correlated to mildly symptomatic, 8-19 correlated to moderately symptomatic and 20-35 correlated to severely symptomatic. A reduction in score from baseline corresponds to improved outcome post procedure. | Mean change in score was calculated for the number of subjects providing data at each follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years |
|
Adverse events were collected from the time of index procedure through the 60 month follow-up assessment.
AEs were adjudicated by an independent urologist who served on the Rezūm II Pivotal Study Clinical Events Committee (CEC).
51 adverse events were reported by 14 subjects. Of the 51 events, 25 events (49.0%) were adjudicated as device related and 32 (62.7%) as procedure related.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rezum Treatment | Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data. Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subject was surgically treated for a pre-existing hernia. | Renal and urinary disorders | Systematic Assessment | This condition was present prior to treatment. Details were not available; the procedure was done at another site. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection (UTI) - Suspected | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Boston Scientific | 9529306000 | teresa.takle-flach@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2012 | Dec 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
|
| Procedure Day, 1 day post procedure, 1 week post procedure, 1 month post procedure, 3 months post procedure ,6 months post procedure |
| Number of Subjects Requiring Catheterization Post Procedure | All subjects were kept at the clinic for observation for 24 hours post-procedure. The number of subjects requiring post-procedure catheterization were recorded. | 1 day post procedure, 1 week post procedure, 1 month post procedure |
| Post Procedure Catheterization Duration | Measures the duration (days) of catheterization for subjects who required catheterization post procedure. Post-procedure catheterization was allowed if the Principal Investigator determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons. | 1 month post procedure |
| Lesion Characteristics Via MRI (Changes in Lesion Volume) | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in lesion volume was calculated. | 1 week , 1 month, 3 months, 6 months post procedure |
| Lesion Characteristics Via MRI (Changes in Prostate Volume) | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in prostate volume was calculated. | 1 week, 1 month, 3 months, 6 months post-procedure |
| Lesion Characteristics Via MRI (Changes in Transition Zone Volume) | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in transition (TZ) zone volume was calculated | 1 week, 1 month, 3 months, 6 months post-procedure |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants underwent the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia. They were followed for 5 years for adverse events and quality of life data.
Rezum System: The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.
The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.
|
|
| Other Pre-specified | Intra-procedural and Post-procedural Pain | Intra-procedural and post-procedural pain for each subject was assessed using the Wong Baker Pain Rating scale (0-10 with 0 indicating no pain and 10 indicating worst pain imaginable). Each subject selected the response on the pain scale that he felt best represented his pain level. Unless otherwise noted, the subjects were not given pain medications or anesthesia. All subjects were given an anti-anxiety medication plus a Non-Steroidal Anti-Inflammatory Drug (NSAID) pre-procedure. | Pain score was not collected for 1 subject at each of the following visits: 1 day, 3 month, and 6 month | Posted | Mean | Standard Deviation | score on a scale | Procedure Day, 1 day post procedure, 1 week post procedure, 1 month post procedure, 3 months post procedure ,6 months post procedure |
|
|
|
| Other Pre-specified | Number of Subjects Requiring Catheterization Post Procedure | All subjects were kept at the clinic for observation for 24 hours post-procedure. The number of subjects requiring post-procedure catheterization were recorded. | Number of subjects requiring post-procedure catheterization. Two (2) subjects were catheterized prior to the Rezūm study enrollment and treatment. The decision was made to move forward with treating both subjects. All subjects were observed for 24 hours in the clinic post-procedure. Post-procedure catheterization was allowed if determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons. | Posted | Number | participants | 1 day post procedure, 1 week post procedure, 1 month post procedure |
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|
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| Other Pre-specified | Post Procedure Catheterization Duration | Measures the duration (days) of catheterization for subjects who required catheterization post procedure. Post-procedure catheterization was allowed if the Principal Investigator determined that the subject had symptoms of retention (defined as failure to void within 8 hours post procedure) or required catheterization for other safety reasons. | Data provided for subjects who underwent the Rezūm ablation procedure. | Posted | Mean | Standard Deviation | days | 1 month post procedure |
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| Other Pre-specified | Lesion Characteristics Via MRI (Changes in Lesion Volume) | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in lesion volume was calculated. | One subject (each) did not have MRI available at the 3 month and 6 month follow-up visit. | Posted | Mean | Standard Deviation | percentage of change in lesion volume | 1 week , 1 month, 3 months, 6 months post procedure |
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| Other Pre-specified | Lesion Characteristics Via MRI (Changes in Prostate Volume) | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in prostate volume was calculated. | One subject (each) did not have MRI data available at the 3 month and 6 month visit | Posted | Mean | Standard Deviation | percentage of change in prostate volume | 1 week, 1 month, 3 months, 6 months post-procedure |
|
|
|
| Other Pre-specified | Lesion Characteristics Via MRI (Changes in Transition Zone Volume) | Lesion size and treated tissue resorption rate was measured by gadolinium enhanced MRI on all subjects at 1 week, 1 month, 3 months, and 6 months post-procedure. The percent change in transition (TZ) zone volume was calculated | One subject (each) did not have MRI available at the 3 month and 6 month visit | Posted | Mean | Standard Deviation | percentage of change in TZ volume | 1 week, 1 month, 3 months, 6 months post-procedure |
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|
| 2 |
| 15 |
| 3 |
| 15 |
| 14 |
| 15 |
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| Adenocarcinoma | Renal and urinary disorders | Systematic Assessment | At 1 year follow up subjects PSA was 15.4. A prostate biopsy was scheduled. Biopsy results positive for Adenocarcinoma. Subject had a prostatectomy and was exited from the study. |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment | Subject reported urinary retention at 3 month visit; treated medically. Subject reported continued urinary retention with fever and dysuria. A UTI was diagnosed; treated medically. Subsequently treated for retention followed by Prostatectomy. |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Poor Stream | Renal and urinary disorders | Systematic Assessment |
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| Urinary Urgency | Renal and urinary disorders | Systematic Assessment |
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| Infection (non UTI) | Infections and infestations | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Terminal Dribbling | Renal and urinary disorders | Systematic Assessment |
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| Urinary Frequency | Renal and urinary disorders | Systematic Assessment |
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| Hematuria with Clots and Retention | Renal and urinary disorders | Systematic Assessment |
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| Prostatic Urethral Injury | Renal and urinary disorders | Systematic Assessment |
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| UTI - Prophylaxis | Renal and urinary disorders | Systematic Assessment |
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| Ureteral Calculi | Renal and urinary disorders | Systematic Assessment |
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| Urinary Incontinence - Urge | Renal and urinary disorders | Systematic Assessment |
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| D052801 |
| Male Urogenital Diseases |
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| average pain 1 week post-procedure |
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| average pain 1 month post-procedure |
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| average pain 3 months post-procedure |
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| average pain 6 months post-procedure |
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| Title | Measurements |
|---|---|
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| Mean percent change from 1 week to 6 months |
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| Mean percent change from 1 week to 6 months |
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| Mean percent change from 1 week to 6 months |
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