Rezum FIM Optimization Study (Rezum FIM)

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

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

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia; Prostatic Hyperplasia, Benign; Prostatic Hypertrophy; Prostatic Hypertrophy, Benign; Adenoma, Prostatic; Prostatic Adenoma; Rezum
• Intervention / Treatment: Device: Rezum System

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Dominican Republic
  • La Romana, Dominican Republic
    • Clinica Canela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
2. Presence of a penile implant.
3. Any prior minimally invasive intervention (e.g. TUNA,Laser, Microwave) or surgical intervention for the symptoms of BPH.
4. Currently enrolled in another clinical trial.
5. Confirmed or suspected malignancy of prostate or bladder.
6. Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease.
7. Previous pelvic irradiation or radical pelvic surgery.
8. 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).
9. Neurogenic bladder or sphincter abnormalities.
10. Urethral strictures, bladder neck contracture or muscle spasms.
11. Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
12. Subjects who are interested in maintaining fertility.

13. 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
14. Subject is unable or unwilling to go through a "washout" period for the above medications prior to treatment.
15. Subject has chronic urinary retention.
16. Significant urge incontinence.
17. Poor detrusor muscle function.
18. Neurological disorders which might affect bladder or sphincter function.
19. Bladder stones.
20. Renal impairment.
21. In the opinion of the Principal Investigator, subject will not be able to adequately tolerate a rigid cystoscopy-type procedure.
22. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
23. Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.
24. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
25. Biopsy of the prostate within 30 days prior to the Rezūm procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Rezum Treatment; Patients will receive the Rezūm transurethral needle ablation procedure to treat benign prostatic hyperplasia.

Device: 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 Names: Rezum Procedure; Rezum; Water Vapor Ablation; Rezum Delivery Device; Rezum Generator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2012
• Primary Completion (Actual): May 19, 2017
• Study Completion (Actual): May 19, 2017

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Rezum
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Prostatic Diseases; Pathological Conditions, Anatomical; Adenoma; Prostatic Hyperplasia; Hyperplasia; Hypertrophy
• Other Study ID Numbers: 1633-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No