ClinicalTrials.gg
CompletedNCT03395522MT-06Updated Nov 3, 2026

Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH

An interventional study of iTind in BPH, sponsored by Medi-Tate Ltd.. Completed at 12 sites in 6 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Medi-Tate Ltd. (part of Olympus Corporation) · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Now Completed3 sites added+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
149
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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 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.
02

Conditions studied

  • BPH
03

In context

Lead sponsor

Medi-Tate Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.

First submitted before Medi-Tate Ltd. became part of Olympus Corporation.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Subject signed 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
149 participants (actual)

Study arms

  • Experimental
    Device

    ITind device implant

    Device: iTind

Interventions

  • DeviceiTind

    device implanted for 5-7 days

06

What researchers measure

Primary outcomes

  1. IPSS (International Prostate Symptoms Score) Responders Rate

    the Proportion (%) of Total IPSS Responders (3 points) Rate

    Time frame: at Month 6 Visit

Secondary outcomes

  1. Total IPSS (International Prostate Symptoms Score) Score at

    Change from Baseline to Month 6 in Total IPSS Score

    Time frame: 6 months

  2. Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score

    Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score

    Time frame: 6 months

  3. Total SHIM (Sexual Health Inventory for Men ) Score

    Change from Baseline to Month 6 in Total SHIM Score

    Time frame: 6 months

  4. Total ISI (Incontinence Severity Index ) Score

    Change from Baseline to Month 6 in Total ISI Score

    Time frame: 6 months

  5. Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score

    Change from Baseline to Month 6 in Total EJ-MSHQ Score

    Time frame: 6 months

  6. Total Flow

    Change from Baseline to Month 6 in Total Flow

    Time frame: 6 months

  7. Total residual urine

    Change from Baseline to Month 6 in Total residual urine

    Time frame: 6 months

  8. Total Satisfaction Rate

    Change from Baseline to Month 6 in Total Satisfaction Rate

    Time frame: 6 months

  9. IPSS QoL (Quality Of Life) score

    Change from Baseline to Month 6 in IPSS QoL score

    Time frame: 6 months

  10. Recovery Success Rate

    Quality of Recovery Success Rate

    Time frame: 1 month

07

Study locations

12 sites
  • Sydney Adventist Hospital Clinical School of the University of Sydney
    Sydney, Australia
  • Hospital Center University De Bordeaux
    Bordeaux, France
  • Hôpital Cochin
    Paris, France
  • Hôpital Privé des Côtes d'Armor
    Plérin, France
  • University Hospital Frankfurt
    Frankfurt, Germany
  • Medical center - University of Freiburg
    Freiburg im Breisgau, Germany
  • AOU di Catanzaro
    Catanzaro, Italy
  • Azienda Ospedaliera Universitaria San Martino
    Genova, Italy
  • Sant'Andrea Hospital
    Rome, Italy
  • San Orbessano
    Turin, Italy
  • Clínica CEMTRO Ventisquero la Condesa
    Madrid, 42 28035, Spain
  • Cantonal Hospital St. Gallen
    Sankt Gallen, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Nov 3, 2026
Sites
3 sites added, 3 sites removed
Show 3 added (1 Germany, 1 Italy, 1 Switzerland)
  • Medical center - University of Freiburg · Freiburg im Breisgau, Germany
  • Sant'Andrea Hospital · Rome, Italy
  • Cantonal Hospital St. Gallen · Sankt Gallen, Switzerland
Show 3 removed
  • Medical center - University of Freiburg · Freiburg, Germany
  • San'Andrea Hospital · Rome, Italy
  • Cantonal Hospital St. Gallen · Saint Gallen, Switzerland
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Active, not recruiting→Completed
    3 sites added, 3 sites removed
    Show 3 added (1 Germany, 1 Italy, 1 Switzerland)
    • Medical center - University of Freiburg · Freiburg im Breisgau, Germany
    • Sant'Andrea Hospital · Rome, Italy
    • Cantonal Hospital St. Gallen · Sankt Gallen, Switzerland
    Show 3 removed
    • Medical center - University of Freiburg · Freiburg, Germany
    • San'Andrea Hospital · Rome, Italy
    • Cantonal Hospital St. Gallen · Saint Gallen, Switzerland
    + 4 other changes: verification date, date precision, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03395522
Lead sponsor
Medi-Tate Ltd.
Responsible party
Sponsor
First posted
Jan 10, 2018
Start date
Feb 18, 2018
Primary completion
Jun 18, 2023
Completion
Apr 25, 2025
Last update
Nov 3, 2026

Study contacts

Sabrina De Cillis, MD
principal investigator · S. Andrea Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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