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

NCT03395522 | Unknown

• 1 other identifier: MT-06
• Study Type: interventional
• Target: 149
• Locations: 6 countries
• Sites: 12

Brief 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.

Conditions

BPH

Outcome Measures

Primary Outcomes (1)

• IPSS (International Prostate Symptoms Score) Responders Rate

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

  at Month 6 Visit

Secondary Outcomes (10)

• Total IPSS (International Prostate Symptoms Score) Score at

  6 months

• Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score

  6 months

• Total SHIM (Sexual Health Inventory for Men ) Score

  6 months

• Total ISI (Incontinence Severity Index ) Score

  6 months

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

  6 months

Study Arms (1)

Device

EXPERIMENTAL

ITind device implant

Device: iTind

Interventions

iTind DEVICE

device implanted for 5-7 days

Device

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male with symptomatic BPH
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Obstructing median lobe or any other anatomical or physiological pathology that can interfere the device implantation as assessed by cystoscopy.

Sponsors & Collaborators

• Medi-Tate Ltd.: lead

Study Sites (12)

Sydney Adventist Hospital Clinical School of the University of Sydney

Sydney, Australia

Location

Hospital Center University De Bordeaux

Bordeaux, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Privé des Côtes d'Armor

Plérin, France

Location

University Hospital Frankfurt

Frankfurt, Germany

Location

Medical center - University of Freiburg

Freiburg im Breisgau, Germany

Location

AOU di Catanzaro

Catanzaro, Italy

Location

Azienda Ospedaliera Universitaria San Martino

Genova, Italy

Location

San'Andrea Hospital

Rome, Italy

Location

San Orbessano

Turin, Italy

Location

Clínica CEMTRO Ventisquero la Condesa

Madrid, 42 28035, Spain

Location

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

Location

Study Officials

• Francesco Porpiglia, MD

  San Orbessano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: device group only

Study Record Dates

• First Submitted: December 26, 2017
• First Posted: January 10, 2018
• Study Start: February 18, 2018
• Primary Completion: June 18, 2023
• Study Completion: April 25, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); AU (1); FR (3); CH (1); IT (4); ES (1)