50 and older, male only, with BPH With Urinary Obstruction or BPH. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With ≥ 30% Improvement in Symptoms as Measured by the International Prostate Symptom Score (IPSS)Primary· 6 Months
The proportion of the intent-to-treat (ITT) analysis population that responds to the Rezum therapy is reported. A responder is defined as a subject who has an improvement in International Prostate Symptom Score (IPSS) \> 30% from baseline to 6 months post-therapy. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Group
Value
95% CI
Treatment
39
Number of Participants With Post Procedure Device Related Serious ComplicationsPrimary· 6 Months
Assess the composite rate of post procedure device related serious complications in treated subjects through 6 months follow-up.
Group
Value
95% CI
Treatment
0
Number of Subjects With Device-related Retention CatheterizationsSecondary· 6 Month
This safety endpoint will be to characterize the rate of post procedure device-related serious retention catheterizations at 6 months.
Group
Value
95% CI
Treatment
0
Change in Lower Urinary Tract Symptoms as Assessed by the Absolute Change in IPSS Score From Baseline to Follow-upSecondary· Baseline, 6 weeks, 3 months, 6 months, 1 year
The change in IPSS from baseline to each follow-up visit was determined. IPSS scores range from 0 (no symptoms) to 35 (severe symptoms). Improvement in symptoms is shown by a reduction in score.
Change from baseline to 6 weeks post-therapy
Group
Value
95% CI
Treatment
-8.47
-10.49 – -6.45
Change from baseline to 3 months post-therapy
Group
Value
95% CI
Treatment
-10.97
-12.68 – -9.27
Change from baseline to 6 months post-therapy
Group
Value
95% CI
Treatment
-11.62
-13.43 – -9.80
Change from baseline to 12 months post-therapy
Group
Value
95% CI
Treatment
-11.80
-13.57 – -10.03
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected from the first patient in until the termination of the study. All 47 subjects were followed to at least the 6- month follow-up visit..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Prospective, multicenter, single arm clinical trial designed to evaluate the safety of the Rezūm System in treating subjects with symptomatic BPH for prostate sizes \>80cm3 and ≤150 cm3.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 10 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03605745.