BPH
Conditions
Keywords
Aquablation, AQUABEAM, BPH, LUTS
Brief summary
The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).
Interventions
PROCEDUREAquablation
Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.
Sponsors
PROCEPT BioRobotics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Male. * Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention. * Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS. * Patient is mentally capable and willing to sign a study-specific informed consent form.
Exclusion criteria
* Patients 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. * History of gross haematuria. * Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d). * Contraindication to both general and spinal anesthesia. * Any severe illness that would prevent complete study participation or confound study results. * Subject is unwilling to accept a transfusion should one be required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS score change | 3 months |
Countries
Australia, Germany, Lebanon, New Zealand, United Kingdom
Outcome results
None listed