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Rezum FIM Optimization Study (Rezum FIM)

Primary Purpose

Benign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma

Status

Completed

Phase

Not Applicable

Locations

Dominican Republic

Study Type

Interventional

Intervention

Rezum System

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Rezum

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention.
IPSS score of ≥ 15.
Qmax: Peak flow rate ≤ 15 ml/sec.
Post-void residual (PVR) < 300 ml.
Prostate transverse diameter > 30 mm.
Prostate volume between 20 to 120 gm.
Voided volume ≥ 125 ml.
Subject able to complete the study protocol in the opinion of the Principal Investigator.
Subject must be willing to undergo the procedure without anesthesia.

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:
1. Beta blockers, antihistamines, anticonvulsants, and antispasmodics within 1 week of treatment, unless there is documented evidence of stable dosing for last 6 months (e.g., no dose changes).
2. Alpha blockers, antidepressants, anticholinergics, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
3. 5-alpha reductase inhibitor within the last 6 months
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.

Sites / Locations

Clinica Canela

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rezum Treatment

Arm Description

Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02940392

First Posted

October 19, 2016

Last Updated

February 12, 2021

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02940392

Brief Title

Rezum FIM Optimization Study

Acronym

Rezum FIM

Official Title

Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

March 19, 2012 (Actual)

Primary Completion Date

May 19, 2017 (Actual)

Study Completion Date

May 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Evaluate the effect of the NxThera BPH Rezum System on prostate tissue in subjects suffering from LUTS symptoms secondary to benign prostatic hyperplasia (BPH).

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia, Adenoma, Prostatic, Prostatic Adenoma, Prostatic Hyperplasia, Benign, Prostatic Hypertrophy, Prostatic Hypertrophy, Benign, Rezum

Keywords

Rezum

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rezum Treatment

Arm Type

Experimental

Arm Description

Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Intervention Type

Device

Intervention Name(s)

Rezum System

Other Intervention Name(s)

Rezum Procedure, Rezum, Water Vapor Ablation, Rezum Delivery Device, Rezum Generator

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in International Prostate Symptom Score

Description

Time Frame

Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years

Other Pre-specified Outcome Measures:

Title

Intra-procedural and Post-procedural Pain

Description

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.

Time Frame

Procedure Day, 1 day post procedure, 1 week post procedure, 1 month post procedure, 3 months post procedure ,6 months post procedure

Title

Number of Subjects Requiring Catheterization Post Procedure

Description

All subjects were kept at the clinic for observation for 24 hours post-procedure. The number of subjects requiring post-procedure catheterization were recorded.

Time Frame

1 day post procedure, 1 week post procedure, 1 month post procedure

Title

Post Procedure Catheterization Duration

Description

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.

Time Frame

1 month post procedure

Title

Lesion Characteristics Via MRI (Changes in Lesion Volume)

Description

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.

Time Frame

1 week , 1 month, 3 months, 6 months post procedure

Title

Lesion Characteristics Via MRI (Changes in Prostate Volume)

Description

Time Frame

1 week, 1 month, 3 months, 6 months post-procedure

Title

Lesion Characteristics Via MRI (Changes in Transition Zone Volume)

Description

Time Frame

1 week, 1 month, 3 months, 6 months post-procedure

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects > 45 years of age who have symptomatic / obstructive symptoms secondary to BPH requiring invasive intervention. IPSS score of ≥ 15. Qmax: Peak flow rate ≤ 15 ml/sec. Post-void residual (PVR) < 300 ml. Prostate transverse diameter > 30 mm. Prostate volume between 20 to 120 gm. Voided volume ≥ 125 ml. Subject able to complete the study protocol in the opinion of the Principal Investigator. Subject must be willing to undergo the procedure without anesthesia. 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: Beta blockers, antihistamines, anticonvulsants, and antispasmodics within 1 week of treatment, unless there is documented evidence of stable dosing for last 6 months (e.g., no dose changes). Alpha blockers, antidepressants, anticholinergics, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment. 5-alpha reductase inhibitor within the last 6 months 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.

Facility Information:

Facility Name

Clinica Canela

City

La Romana

Country

Dominican Republic

12. IPD Sharing Statement

Plan to Share IPD

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