Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH (MT-06)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: BPH
• Intervention / Treatment: Device: iTind

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 Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device; ITind device implant	Device: iTind; device implanted for 5-7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPSS (International Prostate Symptoms Score) Responders Rate	the Proportion (%) of Total IPSS Responders (3 points) Rate	at Month 6 Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total IPSS (International Prostate Symptoms Score) Score at	Change from Baseline to Month 6 in Total IPSS Score	6 months
Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score	Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score	6 months
Total SHIM (Sexual Health Inventory for Men ) Score	Change from Baseline to Month 6 in Total SHIM Score	6 months
Total ISI (Incontinence Severity Index ) Score	Change from Baseline to Month 6 in Total ISI Score	6 months
Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score	Change from Baseline to Month 6 in Total EJ-MSHQ Score	6 months
Total Flow	Change from Baseline to Month 6 in Total Flow	6 months
Total residual urine	Change from Baseline to Month 6 in Total residual urine	6 months
Total Satisfaction Rate	Change from Baseline to Month 6 in Total Satisfaction Rate	6 months
IPSS QoL (Quality Of Life) score	Change from Baseline to Month 6 in IPSS QoL score	6 months
Recovery Success Rate	Quality of Recovery Success Rate	1 month

Collaborators and Investigators

• Sponsor: Medi-Tate Ltd.
• Investigators: Principal Investigator: Francesco Porpiglia, MD, San Orbessano

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2018
• Primary Completion (Actual): June 18, 2023
• Study Completion (Estimated): April 25, 2025

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (Actual): January 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MT-06

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No