Post-Market Study to Assess iTind Safety in Comparison to UroLift

Official title

A Post-Market, Prospective, Randomized, Controlled, Multicenter International Study to Assess the Safety of the Temporarily Implanted Nitinol Device (iTind) Compared to the UroLift® System in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Overview

The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.

Detailed description

Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen.

This study is designed to directly compare the safety and effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.

Interventions

• Device iTind
  The iTind is implemented for 5-7 days
• Procedure UroLift
  UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.

Primary outcome measures

• Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months [Time frame: 3 months]

Secondary outcome measures (6)

• Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months [Time frame: 12 month]
• Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure. [Time frame: 3 month]
• Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months [Time frame: 1, 6, 24, and 36 months]
• Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months [Time frame: 1, 3, 6, 12, 24, and 36 months]
• Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, and 36 months [Time frame: 1, 3, 6, 12, 18, 24, and 36 months]
• Difference in reporting between iTind and UroLift groups at 1, 6, 12, 18, 24, and 36, months •Overall incidence of procedure and/or device related adverse events [Time frame: 1, 6, 12, 18, 24, and 36, months]

Eligibility criteria

Inclusion criteria

• 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/ml or if the PSA is 4 - 10 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
• International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 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

Exclusion criteria

• 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 bladder cancer within the last 2 years or currently suspected bladder cancer
• 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/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 treatment if the therapy may potentially cause injury to site (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 if it may prevent insertion of the iTind or UroLift device
• An active urinary tract infection during randomization
• Clinically significant hematuria within the last 3 months or ongoing cystolithiasis
• Prostate volume > 75 cc
• Post-void residual volume (PVR) > 250 mL
• Actively using catheterization or unable to void naturally
• Unable to complete a 2-week washout period for alpha blockers prior to procedure or unable to discontinue 5ARIs or daily use of PDE5 inhibitors by the time of procedure
• Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure
• Known or suspected allergy to nickel, titanium or polyester/polypropylene

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 15 centers

• Mayo Clinic Arizona — Phoenix
• Arizona Urology Specialists — Tucson
• Urology Associates of Central California — Fresno
• Golden State Urology — Sacramento
• NorthShore University Health System Research Institute — Evanston
• Southeast Louisiana Veterans Health Care System — New Orleans
• Minnesota Urology — Woodbury
• The Urology Center — Omaha
• … and 7 more centers

United Kingdom · 4 centers

• Chelsea and Westminster Hospital — Isleworth
• Queen Margaret Hospital — Dunfermline
• Frimley Park Hospital — London
• Norfolk & Norwich University Hospital — Norwich

Identifiers

NCT: NCT04757116 · MT-08

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗