REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men (VAPEUR RCT)
Benign Prostatic Hyperplasia (BPH)
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Prostate, REZŪM, Water vapor thermotherapy, Lower urinary tract symptoms, BPH, LUTS
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Epworth Healthcare
- Australian Clinical Trials
- Centre Hospitalier du Pays d'AixRecruiting
- CHU d'AngersRecruiting
- CHU de BordeauxRecruiting
- CHU Henri Mondor
- CHU GrenobleRecruiting
- Centre Hospitalier Universitaire de LilleRecruiting
- Hôpital Privé La LouvièreRecruiting
- Hospices Civils de LyonRecruiting
- CHU de NiceRecruiting
- Fondation Hôpital Saint-Joseph
- Hôpital BichatRecruiting
- Hôpital CochinRecruiting
- Institut Mutualiste MontsourisRecruiting
- Hôpital privé FranchevilleRecruiting
- Clinique La Croix du SudRecruiting
- CHU de RennesRecruiting
- CHU de RouenRecruiting
- Clinique Saint HilaireRecruiting
- Centre Hospitalier Privé Saint GrégoireRecruiting
- CHU de ToulouseRecruiting
- Clinique PasteurRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
REZŪM
Dual Drug Therapy
Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use (IFU). The REZŪM System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men with a prostate volume ≥ 30 ml. The REZŪM System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. 1:1 randomization will occur via the electronic data capture (EDC) system.
Subjects assigned to dual drug therapy will be treated with the local formulary preferred choice of commercially available urinary selective alpha blocker and 5-alpha reductase inhibitor. This arm will therefore represent local standard of care.