Clinical trial NCT04838769: REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
Official title: Water Vapor Thermotherapy vs. Combination Pharmacotherapy for Symptomatic Benign Prostatic Hyperplasia Refractory to Alpha Blocker Monotherapy in Sexually Active Men: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Keywords: Prostate
REZŪM
Water vapor thermotherapy
Lower urinary tract symptoms
BPH
LUTS
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 154
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: International Prostate Symptom Score (IPSS) change
timeFrame: From Baseline to 12 months
measure: Male Sexual Health Questionnaire (MSHQ) total score change
timeFrame: From Baseline to 12 months
Secondary outcomes:
measure: Disease Progression
timeFrame: End of available follow-up, up to 24 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Epworth Healthcare
city: Wahroonga
country: Australia
facility: Australian Clinical Trials
city: Aix-en-Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Lille
country: France
facility: Hôpital Privé La Louvière
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital Bichat
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Perigueux
country: France
facility: Hôpital privé Francheville
city: Quint-Fonsegrives
country: France
facility: Clinique La Croix du Sud
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint-Grégoire
country: France
facility: Centre Hospitalier Privé Saint Grégoire
city: Toulouse
country: France
facility: CHU de Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: CHU Rennes, Hôpital Pontchaillou
name: Romain Mathieu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Bichat
name: Evanguelos Xylinas, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References: