NCT02506465

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

February 8, 2022

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

July 14, 2015

Results QC Date

December 19, 2021

Last Update Submit

February 16, 2022

Conditions

Benign Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Qmax Measurement

    3 months

  • PVR

    3 months

  • IIEF Questionnaire

    3 months

  • SHIM

    3 months

Study Arms (2)

iTind arm

EXPERIMENTAL

iTind implant is implant during the study for 5-7 days.

Device: iTIND

Sham arm

SHAM COMPARATOR

Foley catheter is used during the study

Procedure: Sham Arm

Interventions

iTINDDEVICE

Temporary Implantable Nitinol Device (iTIND)

iTind arm
Sham ArmPROCEDURE

Foley catheter will be placed and immediately removed.

Sham arm

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject signed informed consent form (ICF)
  • Age 50 and above
  • Male with symptomatic BPH.
  • IPSS symptom severity score ≥ 10
  • 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.
  • Prostate volume between 25 ml to 75 ml (assessed by ultrasound)
  • 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)
  • Subject able to comply with the study protocol
  • Normal Urinalysis and urine culture

You may not qualify if:

  • Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
  • Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes
  • A post void residual (PVR) volume \> 250 ml measured by ultrasound or acute urinary retention
  • Compromised renal function (i.e., serum creatinine level \> 1.8 mg/dl, or upper tract disease);
  • Confirmed or suspected bladder cancer;
  • Recent (within 3 months) cystolithiasis or hematuria;
  • Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
  • An active urinary tract infection.
  • Enrolled in another treatment trial for any disease within the past 30 days.
  • 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;
  • Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
  • Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
  • History of prostatitis within the past 5 years.
  • Median lobe obstruction of the prostate.
  • 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).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

Chesapeake Urology Research Associates

Baltimore, Maryland, 21209, United States

Location

Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Winthrop University

Garden City, New York, 11501, United States

Location

St John's Episcopal

Lawrence, New York, 11691, United States

Location

Integrated Medical Professionals

Long Island City, New York, 11735, United States

Location

Manhattan Medical research

Manhattan, New York, 10016, United States

Location

Weill cornell

Manhattan, New York, 10065, United States

Location

Premier Urology Group

New York, New York, 08857, United States

Location

Primier Medical Center

Poughkeepsie, New York, 12601, United States

Location

Carolina Uro Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

CIUSS de l'Estrie-CHUS

Sherbrooke, Quebec, Canada

Location

Toronto

Toronto, Canada

Location

Related Publications (1)

  • 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.

    PMID: 36070450DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Limitations and Caveats

Since the study included specific inclusion criteria in regards to age, IPSS, Qmax and prostate volume, our results are not generalizable to all men with LUTS secondary to BPH.

Results Point of Contact

Title
Sivan Baker
Organization
Medi-Tate / Olympus
sivan.baker@olympus.com
+97247701839

Study Officials

  • Sheldon Pike, MD

    St. John's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 23, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

February 28, 2022

Results First Posted

February 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)US(11)