Robotic treatment for urinary symptoms in older men
AQUABEAM® Robotic System and Ultrasound Accessories (AQUA Study)
This study is testing a new robotic treatment to see if it can help older men with urinary problems caused by an enlarged prostate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05157529 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the AQUABEAM Robotic System combined with ultrasound technology for treating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). The AQUABEAM system uses a precise water jet to ablate prostate tissue, aiming to relieve bladder outlet obstruction. The study includes men aged 65 and older who experience moderate to severe LUTS and are willing to participate in the trial. Participants will be monitored for their response to the treatment and any associated outcomes.
Who should consider this trial
Good fit: Ideal candidates are older men diagnosed with LUTS due to BPH who can comply with study protocols.
Not a fit: Patients who are unable to stop anticoagulants or have contraindications for anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for older men suffering from urinary symptoms related to BPH.
How similar studies have performed: Other studies have shown promising results with robotic and minimally invasive approaches for treating BPH, suggesting potential for success with this novel method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * a) Patient has diagnosis of LUTS due to BPH * b) Patient is mentally capable and willing to sign a study-specific informed consent form * c) Patient is able and willing to follow study instructions and likely to attend and complete all required study visits Exclusion Criteria: * a) Patient is unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti- inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care * b) Contraindications for general and spinal anesthesia * c) Patient is unwilling to accept a blood transfusion if required
Where this trial is running
Montreal, Quebec
- Centre Hospitalier de l'université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Naeem Bhojani, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Naeem Bhojani, MD
- Email: naeem.bhojani@gmail.com
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.