Pivotal Study to Assess the Safety and Effectiveness of the iTind Device

Multi-center Prospective Study to Assess the Safety and Effectiveness of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).

Study Overview

• Status: Completed
• Conditions: Benign Prostate Hyperplasia
• Intervention / Treatment: Device: iTIND; Procedure: Sham Arm

Detailed Description

Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with symptomatic BPH.

A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria.

Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up.

iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
    • Toronto
  • Quebec
    • Sherbrooke, Quebec, Canada
      • CIUSS de l'Estrie-CHUS
• United States
  • Florida
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center Of Florida
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Chesapeake Urology Research Associates
  • New York
    • Brooklyn, New York, United States, 11215
      • Methodist Hospital
    • Garden City, New York, United States, 11501
      • Winthrop University
    • Lawrence, New York, United States, 11691
      • St John's Episcopal
    • Long Island City, New York, United States, 11735
      • Integrated Medical Professionals
    • Manhattan, New York, United States, 10016
      • Manhattan Medical Research
    • Manhattan, New York, United States, 10065
      • Weill Cornell
    • New York, New York, United States, 08857
      • Premier Urology Group
    • Poughkeepsie, New York, United States, 12601
      • Primier Medical Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Uro Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Subject signed informed consent form (ICF)
2. Age 50 and above
3. Male with symptomatic BPH.
4. IPSS symptom severity score ≥ 10
5. Peak urinary flow of < 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial.
6. Prostate volume between 25 ml to 75 ml (assessed by ultrasound)
7. Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP)
8. Subject able to comply with the study protocol
9. Normal Urinalysis and urine culture

Exclusion Criteria:

1. Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
2. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes
3. A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention
4. Compromised renal function (i.e., serum creatinine level > 1.8 mg/dl, or upper tract disease);
5. Confirmed or suspected bladder cancer;
6. Recent (within 3 months) cystolithiasis or hematuria;
7. Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
8. An active urinary tract infection.
9. Enrolled in another treatment trial for any disease within the past 30 days.
10. Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
11. Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
12. Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
13. History of prostatitis within the past 5 years.
14. Median lobe obstruction of the prostate.
15. Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years).
16. Any serious medical condition likely to impede successful completion of the study
17. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
18. Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period.
19. Baseline PSA ≥ 10 ng/ml.
20. Positive DRE.
21. Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative prostate biopsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iTind arm; iTind implant is implant during the study for 5-7 days.	Device: iTIND; Temporary Implantable Nitinol Device (iTIND)
Sham Comparator: Sham arm; Foley catheter is used during the study	Procedure: Sham Arm; Foley catheter will be placed and immediately removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Month 3 Results in the IPSS Score in Both Arms.	Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qmax Measurement	Month 3 results in Qmax (maximum urinary flow rate)	3 months
PVR	Month 3 results in PVR (post-void residual urine volume)	3 months
IIEF Questionnaire	The International Index of Erectile Function score. Scale: minimum 6, maximum 75. Higher values are better. Month 3 results in IIEF.	3 months
SHIM	The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM.	3 months

Collaborators and Investigators

• Sponsor: Medi-Tate Ltd.
• Investigators: Principal Investigator: Sheldon Pike, MD, St. John's Hospital

Publications and helpful links

General Publications

• Elterman D, Alshak MN, Martinez Diaz S, Shore N, Gittleman M, Motola J, Pike S, Hermann C, Terens W, Kohan A, Gonzalez R, Katz A, Schiff J, Goldfischer E, Grunberger I, Tu L, Kaminetsky J, Chughtai B. An Evaluation of Sexual Function in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia in Men Treated with the Temporarily Implanted Nitinol Device. J Endourol. 2023 Jan;37(1):74-79. doi: 10.1089/end.2022.0226. Epub 2022 Oct 3.

Helpful Links

• Company website

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 22, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: MT-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No