Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH
- Conditions
- BPH
- Interventions
- Device: iTind
- Registration Number
- NCT03395522
- Lead Sponsor
- Medi-Tate Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 149
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device iTind ITind device implant
- Primary Outcome Measures
Name Time Method IPSS (International Prostate Symptoms Score) Responders Rate at Month 6 Visit the Proportion (%) of Total IPSS Responders (3 points) Rate
- Secondary Outcome Measures
Name Time Method 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
Total Flow 6 months Change from Baseline to Month 6 in Total Flow
Total IPSS (International Prostate Symptoms Score) Score at 6 months Change from Baseline to Month 6 in Total IPSS Score
Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score 6 months Change from Baseline to Month 6 in Total IPSS Urinary Symptoms 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 SHIM (Sexual Health Inventory for Men ) Score 6 months Change from Baseline to Month 6 in Total SHIM Score
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
Trial Locations
- Locations (12)
Cantonal Hospital St. Gallen
🇨🇭Saint Gallen, Switzerland
AOU di Catanzaro
🇮🇹Catanzaro, Italy
Hôpital Cochin
🇫🇷Paris, France
Sydney Adventist Hospital Clinical School of the University of Sydney
🇦🇺Sydney, Australia
Hospital Center University De Bordeaux
🇫🇷Bordeaux, France
Hôpital Privé des Côtes d'Armor
🇫🇷Plérin, France
University Hospital Frankfurt
🇩🇪Frankfurt, Germany
Medical center - University of Freiburg
🇩🇪Freiburg, Germany
Azienda Ospedaliera Universitaria San Martino
🇮🇹Genova, Italy
San'Andrea Hospital
🇮🇹Rome, Italy
Clínica CEMTRO Ventisquero la Condesa
🇪🇸Madrid, Spain
San Orbessano
🇮🇹Turin, Italy