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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

TREATMENT

Phase

Trial ID

NCT04838769

Intervention or treatment

DEVICE: REZŪM

DRUG: alpha blocker and 5-alpha reductase inhibitor

Conditions

• Benign Prostatic Hyperplasia (BPH)

Image related to Benign Prostatic Hyperplasia (BPH)

Condition: Benign Prostatic Hyperplasia (BPH)
DEVICE: REZŪM and other drugs
Melbourne, Not Specified, Australia and more
Sponsor: Boston Scientific Corporation

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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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

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/Arm	Intervention/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.

Participant Group/Arm

Intervention/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 Measure	Primary Outcome Description	Primary Outcome Time Frame
International Prostate Symptom Score (IPSS) change	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.	From Baseline to 12 months
Male Sexual Health Questionnaire (MSHQ) total score change	Change 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 Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Disease Progression	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	End of available follow-up, up to 24 months

Frequently Asked Questions

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References

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