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AQUABEAM® Robotic System and Ultrasound Accessories

Lower Urinary Tract Symptoms | Benign Prostatic Hyperplasia

Lower urinary symptoms (LUTS) affect many older men and their frequency and severity increase with age. In the age group between 65 and 79 years the rate of men with moderate and severe LUTS is 20 - 25% (Hunter et al. 1994). The complaints are potentially associated with a considerable impairment of the quality of life (Trueman et al. 1999). LUTS in older men are commonly caused by a bladder outlet obstruction (BOO) secondary to benign prostatic enlargement (BPE). The histological term "benign prostatic hyperplasia" (BPH) is frequently used in literature and clinical practice as a synonym for this diagnosis.

Surgical therapy of BPH has continuously evolved in recent years. One of the latest technologies for transurethral prostate desobstruction is the Aquablation therapy, first described in 2015 (AQUABEAM®, PROCEPT BioRobotics, Redwood Shores, CA, USA) (Faber et al 2015). The AQUABEAM Robotic System is the first and only image-guided, heat-free robotic therapy for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is designed for cutting of prostate tissue during a minimally invasive surgical procedure. Once inserted via a transurethral approach and advanced through the urethra and into the prostatic urethra, the device applies an ultrasound-guided water jet that precisely ablates the prostate tissue. Aquablation therapy is unique in that it combines cystoscopic visualization, ultrasound imaging and advanced planning software to provide the surgeon with a multidimensional view of the treatment area. This enables personalized treatment planning for the patient's unique anatomy, improved decisionmaking and real-time monitoring during the procedure.

This prospective single-arm investigational clinical trial aims at assessing the efficacy and safety of the new generation of the AQUABEAM Robotic System (P1G3) and the Apogee 2300 Ultrasound System and compare the percentage of patients who are discharged the day of the surgery among different groups of BPH patients who undergo aquablation using the third generation of the AQUABEAM Robotic System.

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Conditions de participation

  • Sexe:

    MALE

  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

Centre Hospitalier de l'université de Montréal (CHUM)
Centre Hospitalier de l'université de Montréal (CHUM)
Montréal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Naeem Bhojani, MD

[email protected]
514-890-8000
Backup Contact

Kahina Bensaadi, DESS

[email protected]
514-890-8000
Étude parrainée par
Centre hospitalier de l'Université de Montréal (CHUM)
Participants recherchés
Plus d'informations
ID de l'étude: NCT05157529