Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Prostate, REZŪM, Water vapor thermotherapy, Lower urinary tract symptoms, BPH, LUTS
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 monotherapy in sexually active men.
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 in sexually active men. STUDY DESIGN - Multicenter open-label randomized controlled parallel-group post-market trial. STUDY TREATMENTS AND RANDOMIZATION - Subjects will be randomly assigned to REZŪM or dual drug therapy treatments; 1:1 randomization via the electronic data capture (EDC) system. Both treatments are commercially available. Subjects randomized to receive the REZŪM treatment will receive standardized treatment and subjects randomized to dual drug therapy will receive the local formulary preferred choice of urinary selective alpha blocker and 5-alpha reductase inhibitor. VISIT SCHEDULE - Study visits are at: enrollment/baseline, treatment, 3 months, 6 months, and yearly follow-up through 2 years.
Interventions
DEVICEREZŪM
Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.
DRUGalpha blocker and 5-alpha reductase inhibitor
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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Subject is willing and able to answer all domains of MSHQ 3. Completed IPSS questionnaire with score ≥ 13 within 6 months prior to enrollment 4. Peak urinary flow rate (Qmax): ≤ 15 ml/sec with minimum voided volume of ≥ 150 ml within 6 months prior to enrollment 5. Post-void residual (PVR) ≤250 ml within 6 months prior to enrollment 6. Prostate volume ≥ 30 ml as measured by transrectal ultrasound or Magnetic Resonance Imaging within 3 months prior to enrollment 7. Subject is willing and capable of providing informed consent 8. 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) 9. France subjects only: subjects must be affiliated to national security insurance
Exclusion criteria
1. Inability to participate in full duration of study 2. Prior surgical treatment for BPH 3. Increased risk of bleeding 4. Presence of Genitourinary Cancer or other pelvic cancer 5. Functional issues with bladder 6. Presence of active infection in genitourinary tract 7. Structural and Anatomic issues with urinary tract and renal function 8. Concomitant Drug Therapy 9. Temporal restraints and risks for general anaesthesia or comorbidity that would elevate risk of participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) change | From Baseline to 12 months | Primary Statistical Hypothesis: Change in IPSS score will be compared between groups. IPSS score ranges from 0 to 35 with higher scores indicating worse symptoms. |
| Male Sexual Health Questionnaire (MSHQ) total score change | From Baseline to 12 months | Change in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Progression | End of available follow-up, up to 24 months | Disease progression, defined as occurrence of any of the following: * Surgical retreatment for LUTS/BPH * Urinary retention requiring urinary catheterization after 90 days post-treatment * IPSS increase from baseline by ≥ 4 points * Introduction of a new drug agent to treat LUTS/BPH |
Countries
Australia, France
Contacts
PRINCIPAL_INVESTIGATORRomain Mathieu, Professor
CHU Rennes, Hôpital Pontchaillou
PRINCIPAL_INVESTIGATOREvanguelos Xylinas, Ass. Prof.
Hôpital Bichat
Outcome results
None listed