BPHMT-06NCT03395522
Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH
A study testing iTind in people with BPH, run by Medi-Tate Ltd. at 12 sites in 6 countries.
Trial summary
A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study. Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- BPH
- What is being tested?
- iTind
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 18 Feb 2018to 25 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject signed informed consent prior to the performance of any study procedures.
- Male with symptomatic BPH: IPSS symptom severity score ≥ 10
- Peak urinary flow of < 12 ml/sec at flowmetry with minimum voided volume of at least 120 cc.
- Prostate volume 25 ml to 80 ml (as assessed by TRUS)
- Subject that is able to complete the study protocol
- Normal Urinalysis and urine culture.
Who cannot join
- Previous prostate surgery
- Prostate cancer
- Urethral stricture
- Bladder stones
- An active urinary tract infection.
- Obstructing median lobe demonstrated by IPP grade 3 (>1 cm) as assessed by TRUS.
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- Neurological conditions potentially affecting voiding function.
- A post void residual (PVR) volume > 250 ml measured by ultrasound
- Previous diagnosis or treatment for Over Active Bladder
- Acute Urinary Retention
- Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study
- Intra-Operation Exclusion:
- Obstructing median lobe or any other anatomical or physiological pathology that can interfere the device implantation as assessed by cystoscopy.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
Italy4 sites
AOU di Catanzaro
Catanzaro
Azienda Ospedaliera Universitaria San Martino
Genova
Sant'Andrea Hospital
Rome
San Orbessano
Turin
France3 sites
Hospital Center University De Bordeaux
Bordeaux
Hôpital Cochin
Paris
Hôpital Privé des Côtes d'Armor
Plérin
Germany2 sites
University Hospital Frankfurt
Frankfurt
Medical center - University of Freiburg
Freiburg im Breisgau
Australia1 site
Sydney Adventist Hospital Clinical School of the University of Sydney
Sydney
About this study
Official title: One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)
A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.
Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3.
Read the detailed description
Primary Study Objective:
The study's primary objective is to assess the efficacy of the Medi-Tate iTind in subjects with symptomatic BPH by reduction of IPSS) (International Prostate Symptoms Score) score.
Secondary Study Objectives:
- To further evaluate the efficacy of Medi-Tate iTind as determined by increase of maximal urinary peak flow, satisfaction from the device and procedures, sex performance capabilities and ejaculation.
- Safety will be assessed by the rate of complications attributed to the Medi-Tate iTind and its implantation/retrieval procedures.
- Conditions
- BPH
- Being tested
- iTind
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTindDevice
device implanted for 5-7 days
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | ITind device implant Receives: Device: iTind |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSS (International Prostate Symptoms Score) Responders Rate
the Proportion (%) of Total IPSS Responders (3 points) Rate
Measured: at Month 6 Visit
Secondary outcomes (10)
Total IPSS (International Prostate Symptoms Score) Score at
Change from Baseline to Month 6 in Total IPSS Score
Measured: 6 months
Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score
Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score
Measured: 6 months
Total SHIM (Sexual Health Inventory for Men ) Score
Change from Baseline to Month 6 in Total SHIM Score
Measured: 6 months
Total ISI (Incontinence Severity Index ) Score
Change from Baseline to Month 6 in Total ISI Score
Measured: 6 months
Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score
Change from Baseline to Month 6 in Total EJ-MSHQ Score
Measured: 6 months
Total Flow
Change from Baseline to Month 6 in Total Flow
Measured: 6 months
Total residual urine
Change from Baseline to Month 6 in Total residual urine
Measured: 6 months
Total Satisfaction Rate
Change from Baseline to Month 6 in Total Satisfaction Rate
Measured: 6 months
IPSS QoL (Quality Of Life) score
Change from Baseline to Month 6 in IPSS QoL score
Measured: 6 months
Recovery Success Rate
Quality of Recovery Success Rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start18 Feb 2018
- Primary completion18 Jun 2023
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- device group only
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medi-Tate Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabrina De Cillis, MD, Principal investigator, S. Andrea Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395522
- Sponsor's protocol ID
- MT-06
- Acronym
- MT-06
- Status last verified
- Oct 2026
- First submitted
- 26 Dec 2017
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT03395522
- Acronym / sponsor ID
- MT-06 / MT-06
- Conditions
- BPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Medi-Tate Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 18 Jun 2023 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.
Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3.
Detailed description
Primary Study Objective:
The study's primary objective is to assess the efficacy of the Medi-Tate iTind in subjects with symptomatic BPH by reduction of IPSS) (International Prostate Symptoms Score) score.
Secondary Study Objectives:
- To further evaluate the efficacy of Medi-Tate iTind as determined by increase of maximal urinary peak flow, satisfaction from the device and procedures, sex performance capabilities and ejaculation.
- Safety will be assessed by the rate of complications attributed to the Medi-Tate iTind and its implantation/retrieval procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- device group only
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: iTindITind device implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject signed informed consent prior to the performance of any study procedures.
- Male with symptomatic BPH: IPSS symptom severity score ≥ 10
- Peak urinary flow of < 12 ml/sec at flowmetry with minimum voided volume of at least 120 cc.
- Prostate volume 25 ml to 80 ml (as assessed by TRUS)
- Subject that is able to complete the study protocol
Key exclusion criteria (13 listed)
- Previous prostate surgery
- Prostate cancer
- Urethral stricture
- Bladder stones
- An active urinary tract infection.
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 |
|---|---|---|
| iTinddevice implanted for 5-7 days | Device | Device |
Primary outcome
IPSS (International Prostate Symptoms Score) Responders Rate
Time frame: at Month 6 Visit
the Proportion (%) of Total IPSS Responders (3 points) Rate
10 secondary outcomes
Total IPSS (International Prostate Symptoms Score) Score at
Time frame: 6 months
Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score
Time frame: 6 months
Total SHIM (Sexual Health Inventory for Men ) Score
Time frame: 6 months
Total ISI (Incontinence Severity Index ) Score
Time frame: 6 months
Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score
Time frame: 6 months
Total Flow
Time frame: 6 months
Total residual urine
Time frame: 6 months
Total Satisfaction Rate
Time frame: 6 months
IPSS QoL (Quality Of Life) score
Time frame: 6 months
Recovery Success Rate
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for BPH
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Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
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Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
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
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.
Sabrina De Cillis, MD principal investigator
S. Andrea Hospital
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTind in people with BPH, run by Medi-Tate Ltd. at 12 sites in 6 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 6 inclusion and 13 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, France, Germany, Australia, Spain and 1 more country. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IPSS (International Prostate Symptoms Score) Responders Rate (time frame: at Month 6 Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.