Penthrox in Rezūm BPH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2020-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Open-labeled, single-centre study

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia

NCT07017452

Benign Prostate Hypertrophy(BPH)

NOT_YET_RECRUITING PHASE3

Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia

NCT00889707

Benign Prostatic Hyperplasia

COMPLETED PHASE2

Rezum I Pilot Study for Benign Prostatic Hyperplasia

NCT02943070

Prostatic Hyperplasia Benign Prostatic Hyperplasia Adenoma, Prostatic +5 more

COMPLETED NA

Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).

NCT05201131

Urologic Diseases

RECRUITING

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

NCT04838769

Benign Prostatic Hyperplasia (BPH)

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients who have elected Convective Thermal Therapy using Rezūm System for the management of their BPH and fulfilled inclusion and exclusion criteria will sign informed consent form for the study. Patient will use Methoxyflurane inhaler (Penthrox™) on top of standard oral analgesia including oral lorazepam, oral Percocet® (oxycodone and acetaminophen) or oxycodone immediate-release, and intra-urethral lidocaine gel (Xylocaine®). Intravenous propofol will be used as rescue analgesia.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain BPH

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Penthrox

methoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure.

Group Type EXPERIMENTAL

Methoxyflurane

Intervention Type DRUG

Methoxyflurane inhaler before Rezum procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methoxyflurane

Methoxyflurane inhaler before Rezum procedure

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Penthrox

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male subjects of ≥ 18 years of age
* Patient who has elected Convective Thermal Therapy using Rezūm System for the management of their benign prostatic hyperplasia.
* No contra-indication on using Methoxyflurane inhaler (Penthrox™).
* Willing and able to accurately complete the required questionnaires.
* Willing and able to provide signed and dated informed consent.

Exclusion Criteria

* Ongoing use of analgesic agents for chronic pain.
* Concomitant use of nephrotoxic agents.
* INR \> 4.
* Use of Methoxyflurane inhaler (Penthrox™) within the previous 3 months.
* Known allergy to Lorazepam, Percocet/ Oxycodone, or Xylocaine® gel.
* Known personal or familial hypersensitivity to Methoxyflurane inhaler (Penthrox™) or other halogenated anesthetics.
* Clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment.
* An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol.
* Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
* A history of liver dysfunction after previous Methoxyflurane inhaler (Penthrox™) use or other halogenated anesthetics.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No