A Randomized, International Study to Assess the Safety of iTind Compared to UroLift

Benign Prostatic Hyperplasia (BPH) Clinical Trial

— MT-08  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757116
• Other study ID #: MT-08
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Olympus Corporation of the Americas
• Contact: Stephanie Ziegler, BSN
• Phone: 901-827-2056
• Email: stephanie.ziegler[@]olympus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective is to demonstrate the safety of the iTind as compared to the UroLift.

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 information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• 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. Screening PSA < 4 mg/dl* and if performed prior to the Screening/Baseline Visit, the results may be accepted up to 3 months. *Any Screening PSA results that are 4-10 mg/dl must have a negative biopsy performed within 6 months.

5. Prostate volume up to 75 cc (inclusive) documented by TRUS or MRI. The results may be accepted up to 6 months prior to the Screening/Baseline Visit. Imaging performed up to 6 months before enrollment is acceptable if the subject is not on 5ARIs at that time

6. IPSS = 13 measured at the baseline visit

7. Maximum urinary flow rate (Qmax) of = 12 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 confirmed and should be ruled out to the satisfaction of the PI by MRI and/or biopsy

2. Confirmed or suspected bladder cancer within the last 2 years

3. History of prostatitis within the last 2 years

4. Median lobe obstruction of the prostate as confirmed by TRUS or MRI

5. Screening PSA value > 10 mg/dl

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 and/or 5ARIs

17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days

18. Known or suspected allergy to nickel, titanium or polyester/polypropylene

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
Canada	The Stone Centre at Vancouver General Hospital	Vancouver	British Columbia
United Kingdom	Frimley Park Hospital	London
United Kingdom	Kings College Hospital NHS Foundation Trust	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	Arkansas Urology	Little Rock	Arkansas
United States	Southeast Louisiana Veterans Health Care System	New Orleans	Louisiana
United States	The Miriam Hospital	Providence	Rhode Island
United States	Golden State Urology	Sacramento	California
United States	The Urology Place	San Antonio	Texas
United States	Arizona Urology Specialists	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Corporation of the Americas

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety	The primary safety endpoint of this study is superiority of safety parameters within twelve months, defined by any AEs defined by Clavien Dindo classification system (all grades)	48 Months
Secondary	Secondary Efficacy	To compare the differences between study groups at each follow-up visit in: Total IPSS: mean/median change from baseline to 3 months	48 months

External Links

•   Company website