Clinical trial NCT02940392: Rezum FIM Optimization Study
Official title: Rezum First in Man Feasibility Study for the Treatment of BPH With the Rezum System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Adenoma, Prostatic
Prostatic Adenoma
Prostatic Hyperplasia, Benign
Prostatic Hypertrophy
Prostatic Hypertrophy, Benign
Rezum
Keywords: Rezum
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-20
Enrollment: 15
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in International Prostate Symptom Score
timeFrame: Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, annually to 5 years
Secondary outcomes:
Other outcomes:
measure: Intra-procedural and Post-procedural Pain
timeFrame: Procedure Day, 1 day post procedure, 1 week post procedure, 1 month post procedure, 3 months post procedure ,6 months post procedure
measure: Number of Subjects Requiring Catheterization Post Procedure
timeFrame: 1 day post procedure, 1 week post procedure, 1 month post procedure
measure: Post Procedure Catheterization Duration
timeFrame: 1 month post procedure
measure: Lesion Characteristics Via MRI (Changes in Lesion Volume)
timeFrame: 1 week , 1 month, 3 months, 6 months post procedure
measure: Lesion Characteristics Via MRI (Changes in Prostate Volume)
timeFrame: 1 week, 1 month, 3 months, 6 months post-procedure
measure: Lesion Characteristics Via MRI (Changes in Transition Zone Volume)
timeFrame: 1 week, 1 month, 3 months, 6 months post-procedure
Locations:
city: La Romana
country: Dominican Republic
facility: Clinica Canela
Study officials:
References: