Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT02940392
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT02940392
Study Brief:
Protocol Section:
NCT02940392