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REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men

← catalyst calendar

NCT04838769

Sponsored by Boston Scientific Corporation (industry) · BSX — their whole pipeline →.

Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
155actual
Sites
21
Countries
Australia, France

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-09-15actualWhen the study began enrolling
Primary completion2025-12-11actualThe date the last participant is measured for the primary outcome — the readout window
Study completionDec 2026estimatedThe whole study's end, after follow-up
First posted2021-04-09actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-08-12actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Benign Prostatic Hyperplasia (BPH)

Interventions

  • Device: REZŪM
  • Drug: alpha blocker and 5-alpha reductase inhibitor — also filed as Dual Drug Therapy

Primary outcomes

what the primary-completion date above is the date OF
International Prostate Symptom Score (IPSS) change
measured From Baseline to 12 months
Male Sexual Health Questionnaire (MSHQ) total score change
measured From Baseline to 12 months

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