Rezum FIM Optimization Study

Boston Scientific

Status

Completed

Conditions

Prostatic Hypertrophy, Benign

Prostatic Hyperplasia, Benign

Prostatic Hypertrophy

Benign Prostatic Hyperplasia

Adenoma, Prostatic

Rezum

Prostatic Adenoma

Treatments

Device: Rezum System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02940392

1633-001

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

Male

Ages

45+ years old

Volunteers

No 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.