Status:
ACTIVE_NOT_RECRUITING
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
45+ years
Phase:
NA
Brief Summary
The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monoth...
Detailed Description
STUDY OBJECTIVE - To compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy...
Eligibility Criteria
Inclusion
- Sexually active male subjects ≥ 45 years of age who have persistent non-neurogenic lower urinary tract symptoms refractory to first-line treatment with single agent Alpha Adrenoceptor Antagonist therapy
- Subject is willing and able to answer all domains of MSHQ
- Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment
- Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment
- Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment
- Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment
- Subject is willing and capable of providing informed consent
- Subject is willing and capable of participating in all visits associated with this study at an approved clinical study site and at the intervals defined by this Clinical Investigational Plan (CIP)
- France subjects only: subjects must be affiliated to national security insurance
Exclusion
- Inability to participate in full duration of study
- Prior surgical treatment for BPH
- Increased risk of bleeding
- Presence of Genitourinary Cancer or other pelvic cancer
- Functional issues with bladder
- Presence of active infection in genitourinary tract
- Structural and Anatomic issues with urinary tract and renal function
- Concomitant Drug Therapy
- Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2027
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04838769
Start Date
September 15 2021
End Date
March 1 2027
Last Update
December 18 2025
Active Locations (21)
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1
Epworth Healthcare
Melbourne, Australia
2
Australian Clinical Trials
Wahroonga, Australia
3
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France
4
CHU d'Angers
Angers, France