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Thermal Therapy

Treatment for Overactive Bladder (REZUM Trial)

N/A
Waitlist Available
Led By Claus Roehrborn, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

To evaluate the safety and efficacy of the Rezūm System and assess its effect on urinary symptoms secondary to benign prostatic hyperplasia (BPH).

Eligible Conditions
  • Enlarged Prostate
  • Overactive Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up
Safety: Device Related Serious Complications
Secondary outcome measures
Responders at 12 Months
Responders at 3 Months
Responders at 6 Months

Trial Design

2Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Treatment: Rezūm System
Group II: ControlExperimental Treatment1 Intervention
Control: Rigid Cystoscopy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rezum System
2013
N/A
~270
Rigid Cystoscopy
2013
N/A
~240

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
737 Previous Clinical Trials
854,039 Total Patients Enrolled
Claus Roehrborn, MDPrincipal InvestigatorUT Southwestern
2 Previous Clinical Trials
252 Total Patients Enrolled
Kevin McVary, MDPrincipal InvestigatorSouthern Illinois University
2 Previous Clinical Trials
1,491 Total Patients Enrolled
~16 spots leftby Sep 2025
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