Post-Market Study to Assess iTind Safety in Comparison to UroLift
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Interventions
- Procedure: UroLiftDevice: iTind
- Registration Number
- NCT04757116
- Lead Sponsor
- Olympus Corporation of the Americas
- Brief Summary
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
- Detailed Description
UroLift is a treatment for relieving lower urinary tract symptoms (LUTS) secondary to benign Prostatic Hyperplasia (BPH) as a minimally invasive procedure. This procedure has proven to have high efficacy with regards to improving objective and subjective parameters. The iTind is a minimally invasive temporary device designed to relieve LUTS secondary to BPH. This study is designed to compare the minimally invasive iTind device to UroLift.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 206
- Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
- Willing and able to provide informed consent
- Males ≥ 50 years of age or older
- PSA < 4 ng/dl, ng/ml or if the PSA is 4 - 10 ng/dl, ng/ml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months
- Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be accepted up to 6 months prior to Screening if the subject was not on 5-alpha reductase inhibitors (5ARIs) at that time
- International Prostate Symptom Score (IPSS) ≥ 13
- Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL)
- Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits
- History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months
- Confirmed or suspected bladder cancer within the last 2 years
- History of acute bacterial prostatitis within the last 2 years
- Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
- PSA value > 10 ng/dl, ng/ml
- Contraindicated for iTind or UroLift as determined by the PI
- Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes or other neurological disorders that affect bladder function
- Clinically significant bladder diverticulum
- Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter
- Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites or previous rectal surgery (e.g., if a transrectal probe is used), pelvic radiotherapy or radical pelvic surgery, urinary diversion surgery, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or any other invasive treatment to the prostate, or penile prosthesis that may prevent insertion of the iTind or UroLift device
- An active urinary tract infection
- Hematuria or cystolithiasis within the last 3 months
- Prostate volume > 75 cc
- Post-void residual volume (PVR) > 250 mL
- Actively using catheterization or unable to void naturally
- Unable to complete the required washout period for alpha blockers
- Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to randomization
- Known or suspected allergy to nickel, titanium or polyester/polypropylene
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UroLift UroLift The UroLift is a minimally invasive permanent implant iTind arm iTind The iTind is a minimally invasive temporary implant
- Primary Outcome Measures
Name Time Method Incidence of all intraoperative and post-operative complications 3 months Incidence of all intraoperative and post-operative complications (i.e., related to procedure and/or device) at 3 months
- Secondary Outcome Measures
Name Time Method Difference in reporting between iTind and UroLift groups in overall incidence of adverse events. 1, 3, 6, 12, 18, 24, 36, 48, and 60 months Difference in reporting between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months in overall incidence of adverse events.
Difference in change from baseline between iTind and UroLift groups in Short-Form Six-Dimension (SF-6D) v2 1, 3, 6, 12, 24, 36, 48, and 60 months Difference in change of Short-Form Six-Dimension (SF-6D) v2 scores from baseline between iTind and UroLift at 1, 3, 6, 12, 24, 36, 48, and 60 months.
Difference in change from baseline between iTind and UroLift groups in Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD) 1, 3, 6, 12, 24, 36, 48, and 60 months Difference in change of in Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD) scores from baseline between iTind and UroLift at 1, 3, 6, 12, 24, 36, 48, and 60 months.
Difference in rate of re-intervention between iTind and UroLift groups 1, 3, 6, 12, 18, 24, 36, 48, and 60 months Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
Difference in change from baseline between iTind and UroLift groups in International Prostate Symptom Score (IPSS) 1, 3, 6, 12, 24, 36, 48, and 60 months Difference in change of International Prostate Symptom Score (IPSS) from baseline between iTind and UroLift groups at 1, 3, 6, 12, 24, 36, 48, and 60 months.
Difference in change from baseline between iTind and UroLift groups in Sexual Health Inventory for Men (SHIM) 1, 3, 6, 12, 24, 36, 48, and 60 months Difference in change of Sexual Health Inventory for Men (SHIM) scores from baseline between iTind and UroLift at 1, 3, 6, 12, 24, 36, 48, and 60 months.
Trial Locations
- Locations (17)
Minnesota Urology
🇺🇸Woodbury, Minnesota, United States
Feinstein Institutes for Medical Research / Northwell Health
🇺🇸Syosset, New York, United States
The Conrad Pearson Clinic
🇺🇸Germantown, Tennessee, United States
Midtown Urology Associates
🇺🇸Austin, Texas, United States
Arizona Urology Specialists
🇺🇸Tucson, Arizona, United States
Urology Associates of Central California
🇺🇸Fresno, California, United States
Golden State Urology
🇺🇸Sacramento, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
NorthShore University Health System Research Institute
🇺🇸Evanston, Illinois, United States
Southeast Louisiana Veterans Health Care System
🇺🇸New Orleans, Louisiana, United States
Adult & Pediatric Urology
🇺🇸Omaha, Nebraska, United States
The Smith Institute of Urology
🇺🇸Syosset, New York, United States
The Urology Place
🇺🇸San Antonio, Texas, United States
Potomac Urology Center
🇺🇸Alexandria, Virginia, United States
Queen Margaret Hospital
🇬🇧Dunfermline, United Kingdom
Frimley Park Hospital
🇬🇧London, United Kingdom
Norfolk & Norwich University Hospital
🇬🇧Norwich, United Kingdom