Study to Assess the Safety of the Temporarily Implanted Nitinol Device Compared to the Urolift® System in Subjects With Symptomatic Benign Prostatic Hyperplasia

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
  2. Willing and able to provide informed consent
  3. Males ≥ 50 years of age or older
  4. 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
  5. 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
  6. International Prostate Symptom Score (IPSS) ≥ 13
  7. Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL)
  8. Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits

Exclusion Criteria:

  1. 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
  2. Confirmed or suspected bladder cancer within the last 2 years
  3. History of acute bacterial prostatitis within the last 2 years
  4. Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
  5. PSA value > 10 ng/dl, ng/ml
  6. Contraindicated for iTind or UroLift as determined by the PI
  7. 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
  8. Clinically significant bladder diverticulum
  9. Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter
  10. 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
  11. An active urinary tract infection
  12. Hematuria or cystolithiasis within the last 3 months
  13. Prostate volume > 75 cc
  14. Post-void residual volume (PVR) > 250 mL
  15. Actively using catheterization or unable to void naturally
  16. Unable to complete the required washout period for alpha blockers
  17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to randomization
  18. Known or suspected allergy to nickel, titanium or polyester/polypropylene

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/18/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitchell Humphreys, M.D.

Open for enrollment

Contact information:

Revathy Vilasan Shylaja

(480) 574-1466

VilasanShylaja.Revathy@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20579516

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