Benign Prostate HyperplasiaNCT02506465

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

A study testing iTIND in people with Benign Prostate Hyperplasia, run by Medi-Tate Ltd. at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 50 to 80 years, men only
Conditions the study is for: Benign Prostate Hyperplasia
What is being tested?: iTIND
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 185 participants
Where: 13 sitesin 2 countries
Study dates: Jul 2015to Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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

Who cannot join

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;

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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).
Any serious medical condition likely to impede successful completion of the study
Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period.
Baseline PSA ≥ 10 ng/ml.
Positive DRE.
Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative prostate biopsy.

Trial locations and contacts

13 sites in 2 countries.

Country

City, postcode or hospital

13 sites in 2 countries

United States11 sites

Chesapeake Urology Research Associates
Baltimore, Maryland, 21209
Methodist Hospital
Brooklyn, New York, 11215
Winthrop University
Garden City, New York, 11501
St John's Episcopal
Lawrence, New York, 11691
Integrated Medical Professionals
Long Island City, New York, 11735
Manhattan Medical research
Manhattan, New York, 10016
Weill cornell
Manhattan, New York, 10065
Carolina Uro Research Center
Myrtle Beach, South Carolina, 29572
Premier Urology Group
New York, New York, 08857
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Primier Medical Center
Poughkeepsie, New York, 12601

Other trials in United States

Canada2 sites

CIUSS de l'Estrie-CHUS
Sherbrooke, Quebec
Toronto
Toronto

Other trials in Canada

About this study

Official title: 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).

Read the 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.

Conditions: Benign Prostate Hyperplasia
Being tested: iTIND, Sham Arm
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iTINDDevice
Temporary Implantable Nitinol Device (iTIND)
Sham ArmProcedure or surgery
Foley catheter will be placed and immediately removed.

Study groups in NCT02506465
Study group	Role	What they receive
iTind arm	Experimental	iTind implant is implant during the study for 5-7 days. Receives: Device: iTIND
Sham arm	Sham comparator	Foley catheter is used during the study Receives: Procedure: Sham Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (4)

Qmax Measurement
Month 3 results in Qmax (maximum urinary flow rate)
Measured: 3 months
PVR
Month 3 results in PVR (post-void residual urine volume)
Measured: 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.
Measured: 3 months
SHIM
The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Oct 2018

First posted23 Jul 2015 (estimated)
Study startJul 2015
Primary completionOct 2018
Study completionOct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Benign Prostate HyperplasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 185 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02506465
Sponsor's protocol ID: MT-03
Status last verified: Feb 2022
First submitted: 14 Jul 2015
Last updated: 28 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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.
PubMed 36070450

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage

All Benign Prostate Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02506465
Acronym / sponsor ID: MT-03
Conditions: Benign Prostate Hyperplasia
Study type: Interventional
Recruitment status: Completed
Enrolment: 185 participants (actual)
Lead sponsor: Medi-Tate Ltd.Industry (pharma, biotech, devices)
Study start: Jul 2015 (actual)
Primary completion: Oct 2018 (actual)
Study completion: Oct 2018 (actual)
First posted: 23 Jul 2015 (estimated)
Results: Posted 8 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
iTind arm	Experimental	Device: iTINDiTind implant is implant during the study for 5-7 days.
Sham arm	Sham comparator	Procedure: Sham ArmFoley catheter is used during the study

Who may qualify

Ages: 50 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iTINDTemporary Implantable Nitinol Device (iTIND)	Device	iTind arm
Sham ArmFoley catheter will be placed and immediately removed.	Procedure or surgery	Sham arm

Primary outcome

Month 3 Results in the IPSS Score in Both Arms.
Time frame: 3 months
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.

4 secondary outcomes

Qmax Measurement
Time frame: 3 months
PVR
Time frame: 3 months
IIEF Questionnaire
Time frame: 3 months
SHIM
Time frame: 3 months

Results and safety

Results posted to the registry on 8 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
iTind Arm	128	78
Sham Arm	57	57

Primary outcome: Month 3 Results in the IPSS Score in Both Arms.

Time frame: 3 months. Median (Standard Deviation). Unit: score on a scale

Measure	iTind Arm n = 128	Sham Arm n = 57
Value	12.57 (6.95)	15.8 (9.0)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were documented from implantation day until the first follow up visit at 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
iTind Arm	10 of 128 (7.8%)	45 of 128 (35.2%)	1 of 128
Sham Arm	2 of 57 (3.5%)	5 of 57 (8.8%)	0 of 57

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36070450Elterman 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.
Company websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Benign Prostate Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sheldon Pike, MD principal investigator

St. John's Hospital

13 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing iTIND in people with Benign Prostate Hyperplasia, run by Medi-Tate Ltd. at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Month 3 Results in the IPSS Score in Both Arms. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02506465, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.