BPH
Conditions
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.
Interventions
DEVICEiTind
device implanted for 5-7 days
Sponsors
Medi-Tate Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
device group only
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IPSS (International Prostate Symptoms Score) Responders Rate | at Month 6 Visit | the Proportion (%) of Total IPSS Responders (3 points) Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total residual urine | 6 months | Change from Baseline to Month 6 in Total residual urine |
| Total Satisfaction Rate | 6 months | Change from Baseline to Month 6 in Total Satisfaction Rate |
| IPSS QoL (Quality Of Life) score | 6 months | Change from Baseline to Month 6 in IPSS QoL score |
| Recovery Success Rate | 1 month | Quality of Recovery Success Rate |
| Total Flow | 6 months | Change from Baseline to Month 6 in Total Flow |
| Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score | 6 months | Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score |
| Total SHIM (Sexual Health Inventory for Men ) Score | 6 months | Change from Baseline to Month 6 in Total SHIM Score |
| Total ISI (Incontinence Severity Index ) Score | 6 months | Change from Baseline to Month 6 in Total ISI Score |
| Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score | 6 months | Change from Baseline to Month 6 in Total EJ-MSHQ Score |
| Total IPSS (International Prostate Symptoms Score) Score at | 6 months | Change from Baseline to Month 6 in Total IPSS Score |
Countries
Australia, France, Germany, Italy, Spain, Switzerland
Outcome results
None listed