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Recruiting NCT05169892

Aquablation in Benign Prostatic Hyperplasia in Canada

Observational Urologic Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aquablation.
Who it may be relevant to
Registry conditions: Urologic Diseases. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Canadian Cohort of Aquablation, a Robotically Executed, Surgeon-guided, High-pressure Water Jet Ablation Therapy for Endoscopic Resection of Prostate Tissue, in Benign Prostatic Hyperplasia (BPH).

Overview

To document the clinical outcome of Aquablation therapy for BPH patient in Canadian cohort.

Detailed description

Patients will be followed up for 3 years as standard of care.

Interventions

  • Procedure Aquablation
    Aquablation

Primary outcome measures

  • Maximum flow rate (Q-max) [Time frame: Baseline]
  • Post-Void Residual (PVR) volume [Time frame: Baseline]
  • Maximum flow rate (Q-max) [Time frame: 1 month after surgery]
  • Post-Void Residual (PVR) volume [Time frame: 1 month after surgery]
  • Maximum flow rate (Q-max) [Time frame: 3 months after surgery]
  • Post-Void Residual (PVR) volume [Time frame: 3 months after surgery]
  • Maximum flow rate (Q-max) [Time frame: 6 months after surgery]
  • Post-Void Residual (PVR) volume [Time frame: 6 months after surgery]
  • Maximum flow rate (Q-max) [Time frame: 12 months after surgery]
  • Post-Void Residual (PVR) volume [Time frame: 12 months after surgery]

Eligibility criteria

Inclusion criteria

  • Primary diagnosis of Benign Prostate Hypertrophy (BPH)
  • Male subjects of ≥ 18 years of age
  • Candidate for Aquablation therapy as per clinical decision of Investigator
  • Willing and able to accurately complete questionnaires
  • Willing and able to provide signed and dated informed consent

Exclusion criteria

  • Characteristics indicating a poor compliance with study protocol requirements.
  • Disease or other health condition that is not suitable for this study.
  • Unable or unwilling to provide signed informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Dean Elterman — Toronto

Identifiers

NCT: NCT05169892 · Aquablation in BPH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗