Overview
Robotic assisted surgery for benign prostatic hyperplasia (BPH)
Description
A single-arm open label pilot study observing intraoperative and postoperative outcomes of the Beacon Platform in HoLEP.
Eligibility
Inclusion Criteria:
- Male
- Subject has diagnosis of lower urinary tract symptoms and/or urinary retention due to benign prostatic enlargement causing bladder outlet obstruction,
- Subject is able and willing to comply with all the assessments of the study,
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the informed consent form,
- ≥ 45 years of Age,
- Prostate volume 40 - 120 cc by transrectal ultrasound (TRUS), magnetic resonance imaging (MRI), or computed tomography (CT), measured within one year prior to procedure,
- The subject is indicated for undergoing HoLEP procedure
Exclusion Criteria:
- Urethral stricture, meatal stenosis, or bladder neck contracture - either current or recurrent,
- History of prostate cancer or current/suspected bladder cancer,
- Prostate cancer should be ruled out before participation to the satisfaction of the investigator if Prostate-Specific Antigen (PSA) is above acceptable thresholds,
- History of other diseases causing voiding dysfunction including urinary retention (e.g., diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
- Subjects with overactive bladder in the absence of benign prostatic obstruction as determined by the investigator,
- Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated)
- Previous pelvic irradiation or radical pelvic surgery,
- Previous prostate surgery, including enucleation, resection, vaporization, thermotherapy, ablation, stenting, or prostatic urethral lift,
- Inability to stop taking anticoagulants for at least 3 days prior to the procedure or antiplatelets and/or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy is permitted),
- Any severe illness that would prevent complete study participation or confound study results.
- Bleeding tendency disorders,
- Future fertility concerns,
- Subject has any other disease or condition(s) that would interfere with completion of the study and follow-up assessments, would increase risks of the procedure, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect outcomes,
- Concomitant participation in another interventional study