Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2012-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rezum Treatment
Patients received the Rezum transurethral needle ablation procedure to treat benign prostatic hyperplasia.
Rezum System
The Rezūm System treats 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.
Interventions
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Rezum System
The Rezūm System treats 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 investigator.
9. Life expectancy of at least one year.
Exclusion Criteria
2. Presence of a penile implant.
3. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave) or surgical intervention for the symptoms of BPH.
4. Currently enrolled or has been enrolled in another trial in the past 30 days.
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 catherization specimen)
9. Neurogenic bladder or sphincter abnormalities.
10. Urethral strictures, bladder neck contracture or muscle spasms.
12. Subjects interested in maintaining fertility.
13. Use of concomitant medications to include the following:
1. Use of, antihistamines, and antispasmodics within 1 week of treatment unless there is documented evidence stable dosing for last 6 months (no dose changes).
2. Use of alpha blockers, androgens, or gonadotropin-releasing hormonal analogs within 2 weeks of treatment.
3. Use of 5-alpha reductase inhibitor within the last 6 months
4. Use of antidepressants, anticholinergics, anticonvulsants, and beta blockers unless there is documented evidence of stable dosing
14. Subject is unable or unwilling to go through the "washout" period prior to treatment.
15. Subject has chronic urinary retention.
16. Post-void residual volume \> 300 ml.
17. Significant urge incontinence.
18. Poor detrusor muscle function.
19. Neurological disorders which might affect bladder or sphincter function.
20. Urinary sphincter abnormalities.
21. Bladder stones.
22. Evidence of bacterial prostatitis or symptoms of epididymitis
23. Renal impairment or serum creatinine \> 2.0 mg/dl
24. In the physician's opinion, subject cannot tolerate a cystoscopy procedure well.
25. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the required follow-up requirements.
26. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study.
27. Peripheral arterial disease with intermittent claudication or Leriches Syndrome (i.e., claudication of the buttocks or perineum).
28. Biopsy of prostate within 30 days of procedure.
45 Years
MALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin M Hagelin
Role: STUDY_DIRECTOR
Program Manager, Clinical Affairs, Boston Scientific
Locations
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University Hospital
Brno, , Czechia
Clinica Canela
La Romana, , Dominican Republic
Urologcentrum
Stockholm, , Sweden
Countries
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Other Identifiers
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1189-001
Identifier Type: -
Identifier Source: org_study_id
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