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

Medi-Tate

Status: Active, not recruiting

Conditions: BPH

Treatments: Device: iTind

Study type: Interventional

Funder types: Industry

Identifiers

NCT03395522

MT-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

149 participants in 1 patient group

Device

Experimental group

Description:

ITind device implant

Treatment:

Device: iTind