OPEN WATER Registry
Research type
Research Study
Full title
OPEN WATER, Global Post-Market Registry using Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue -- TP0118
IRAS ID
219973
Contact name
Angela Lee
Contact email
Sponsor organisation
Procept BioRobotics
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
Benign prostatic hyperplasia (BPH), or enlargement of the prostate due to benign growth of glandular tissue, is a very common disease of older men. Prostatic tissue may compress the urethral canal, causing partial or sometimes complete obstruction of the prostatic urethra, which interferes with the normal flow of urine. Symptoms of BPH include urinary hesitancy, frequent urination, dysuria, increased risk of urinary tract infections and urinary retention.
Therapy for BPH includes medication and various surgical approaches. While medication is first-line therapy, many men do not have adequate responses to treatment. The standard surgical approach is transurethral resection of the prostate (TURP). TURP involves invasive removal of prostate tissue using electrocautery and/or sharp dissection. While TURP remains the gold standard for surgical treatment, it carries risks, including bleeding, clot retention/colic, bladder wall injury, hyponatremia (water intoxication), bladder neck contracture, urinary incontinence, retrograde ejaculation, and erectile dysfunction. Use of the AQUABEAM System intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms, is an alternative to traditional TURP. Clinical experience demonstrates that the mechanism of action, controlled delivery of high-velocity saline stream, will potentially reduce complications including sexual dysfunction and result in an effective and rapid treatment option for patients with symptomatic BPH.
The OPEN WATER Study, being conducted at NHS centres in the UK as well as globally, is a post-market registry with the objective of characterising the effectiveness of the market-approved AquaBeam System at improving lower urinary tract symptoms resulting from BPH. Up to 200 subjects globally with symptomatic BPH and who are suitable for surgical treatment will be included in the study. Eligibility is determined by prostate size as measured by ultrasound, and other clinical factors. Each subject is followed postoperatively for 12 months.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0014
Date of REC Opinion
31 Jan 2017
REC opinion
Favourable Opinion