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

BPH Clinical Trial

— MT-06  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03395522
• Other study ID #: MT-06
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 18, 2018
• Est. completion date: April 25, 2025

Study information

• Verified date: October 2023
• Source: Medi-Tate Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 149
• Est. completion date: April 25, 2025
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BPH

Intervention

Device:
• iTind
device implanted for 5-7 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medi-Tate Ltd.

Countries where clinical trial is conducted

Australia,  France,  Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS (International Prostate Symptoms Score) Responders Rate	the Proportion (%) of Total IPSS Responders (3 points) Rate	at Month 6 Visit
Secondary	Total IPSS (International Prostate Symptoms Score) Score at	Change from Baseline to Month 6 in Total IPSS Score	6 months
Secondary	Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score	Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score	6 months
Secondary	Total SHIM (Sexual Health Inventory for Men ) Score	Change from Baseline to Month 6 in Total SHIM Score	6 months
Secondary	Total ISI (Incontinence Severity Index ) Score	Change from Baseline to Month 6 in Total ISI Score	6 months
Secondary	Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score	Change from Baseline to Month 6 in Total EJ-MSHQ Score	6 months
Secondary	Total Flow	Change from Baseline to Month 6 in Total Flow	6 months
Secondary	Total residual urine	Change from Baseline to Month 6 in Total residual urine	6 months
Secondary	Total Satisfaction Rate	Change from Baseline to Month 6 in Total Satisfaction Rate	6 months
Secondary	IPSS QoL (Quality Of Life) score	Change from Baseline to Month 6 in IPSS QoL score	6 months
Secondary	Recovery Success Rate	Quality of Recovery Success Rate	1 month