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REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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
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    Eligibility

    Age eligible for study : 45 and older

    Healthy volunteers accepted : No

    Gender eligible for study: Male

    Things to know

    Study dates

    Study start: 2021-09-15

    Primary completion: 2026-02-01

    Study completion finish: 2027-02-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04838769

    Intervention or treatment

    DEVICE: REZŪM

    DRUG: alpha blocker and 5-alpha reductase inhibitor

    Conditions

    • Benign Prostatic Hyperplasia (BPH)

    Find a site

    Closest Location:

    Epworth Healthcare

    Research sites nearby

    Select from list below to view details:

    • Epworth Healthcare

      Melbourne, Not Specified, Australia

    • Australian Clinical Trials

      Wahroonga, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: REZŪM
    • 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.
    DEVICE: REZŪM
    • Subjects randomized to receive the REZŪM treatment will receive standardized treatment, following the Instruction for Use.
    ACTIVE_COMPARATOR: Dual Drug Therapy
    • 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.
    DRUG: alpha 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.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    International Prostate Symptom Score (IPSS) changePrimary Statistical Hypothesis: Change in IPSS score will be compared between groups. IPSS score ranges from 0 to 35 with higher scores indicating worse symptoms.From Baseline to 12 months
    Male Sexual Health Questionnaire (MSHQ) total score changeChange in MHSQ score will be compared between groups. MHSQ score ranges from 0 to 125 with higher scores indicating better outcomes.From Baseline to 12 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Disease ProgressionDisease 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/BPHEnd of available follow-up, up to 24 months

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    References

    Clinical Trials Gov: REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men

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