Benign Prostatic Hyperplasia (BPH) Clinical Trial
— MT-08Official 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)
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
| Status | Recruiting |
| Enrollment | 206 |
| Est. completion date | December 31, 2030 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 50 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Frimley Park Hospital | London | |
| United Kingdom | Norfolk & Norwich University Hospital | Norwich | |
| 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 | Golden State Urology | Sacramento | California |
| United States | The Urology Place | San Antonio | Texas |
| United States | Arizona Urology Specialists | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Olympus Corporation of the Americas |
United States, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Difference between iTind and UroLift groups for concomitant medication usage | Difference between iTind and UroLift groups for the following parameters:
• Concomitant medication usage |
Time frame not specified for exploratory endpoint | |
| Other | Difference between iTind and UroLift groups for Anesthesia type | Difference between iTind and UroLift groups for the following parameters:
• Anesthesia type |
Intraoperative | |
| Other | Difference between iTind and UroLift groups for Procedure time | Difference between iTind and UroLift groups for the following parameters:
• Procedure time |
Intraoperative | |
| Other | Difference between iTind and UroLift groups for Hospital length of stay | Difference between iTind and UroLift groups for the following parameters:
• Hospital length of stay |
Post-procedure | |
| Other | Difference between iTind and UroLift groups for Post-operative foley catheterization | Difference between iTind and UroLift groups for the following parameters:
• Post-operative foley catheterization |
Post-procedure | |
| Other | Difference between iTind and UroLift groups for Number of UroLift impants (UroLift arm only) | Difference between iTind and UroLift groups for the following parameters:
• Number of UroLift impants (UroLift arm only) |
Intraoperative | |
| Other | Difference between iTind and UroLift groups for iTind retrieval time (iTind arm only) | Difference between iTind and UroLift groups for the following parameters:
• iTind retrieval time (iTind arm only) |
Intraoperative | |
| Other | Difference between iTind and UroLift groups for iTind post-retrieval foley catheterization (iTind arm only) | Difference between iTind and UroLift groups for the following parameters:
• iTind post-retrieval foley catheterization (iTind arm only) |
Post-procedure | |
| Primary | Incidence of all intraoperative and post-operative complications | Incidence of all intraoperative and post-operative complications (i.e., related to procedure and/or device) at 3 months | 3 months | |
| Secondary | Difference in change from baseline between iTind and UroLift groups in International Prostate Symptom Score (IPSS) | 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. | 1, 3, 6, 12, 24, 36, 48, and 60 months | |
| Secondary | Difference in change from baseline between iTind and UroLift groups in Sexual Health Inventory for Men (SHIM) | 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. | 1, 3, 6, 12, 24, 36, 48, and 60 months | |
| Secondary | Difference in change from baseline between iTind and UroLift groups in Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD) | 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. | 1, 3, 6, 12, 24, 36, 48, and 60 months | |
| Secondary | Difference in change from baseline between iTind and UroLift groups in Short-Form Six-Dimension (SF-6D) v2 | 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. | 1, 3, 6, 12, 24, 36, 48, and 60 months | |
| Secondary | Difference in rate of re-intervention between iTind and UroLift groups | Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months | 1, 3, 6, 12, 18, 24, 36, 48, and 60 months | |
| Secondary | Difference in reporting between iTind and UroLift groups in overall incidence of adverse events. | 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. | 1, 3, 6, 12, 18, 24, 36, 48, and 60 months |
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