NCT03395522Active, not recruitingNot Applicable
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)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Medi-Tate Ltd.
- Enrollment
- 149
- Locations
- 12
- Primary Endpoint
- IPSS (International Prostate Symptoms Score) Responders Rate
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Device
Experimental
ITind device implant
Intervention: iTind (Device)
Outcomes
Primary Outcomes
IPSS (International Prostate Symptoms Score) Responders Rate
Time Frame: at Month 6 Visit
the Proportion (%) of Total IPSS Responders (3 points) Rate
Secondary Outcomes
- Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score(6 months)
- IPSS QoL (Quality Of Life) score(6 months)
- Total IPSS (International Prostate Symptoms Score) Score at(6 months)
- Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score(6 months)
- Total ISI (Incontinence Severity Index ) Score(6 months)
- Total Flow(6 months)
- Total residual urine(6 months)
- Total Satisfaction Rate(6 months)
- Total SHIM (Sexual Health Inventory for Men ) Score(6 months)
- Recovery Success Rate(1 month)
Investigators
Study Sites (12)
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