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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Medi-Tate Ltd.
- Enrollment
- 149
- Locations
- 13
- 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.
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 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 EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score(6 months)
- Total SHIM (Sexual Health Inventory for Men ) Score(6 months)
- IPSS QoL (Quality Of Life) score(6 months)
- Recovery Success Rate(1 month)
Investigators
Study Sites (13)
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