Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH (MT-06)
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|ClinicalTrials.gov Identifier: NCT03395522|
Recruitment Status : Active, not recruiting
First Posted : January 10, 2018
Last Update Posted : June 1, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|BPH||Device: iTind||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||149 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||device group only|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||February 18, 2018|
|Estimated Primary Completion Date :||June 18, 2023|
|Estimated Study Completion Date :||April 25, 2025|
ITind device implant
device implanted for 5-7 days
- IPSS (International Prostate Symptoms Score) Responders Rate [ Time Frame: at Month 6 Visit ]the Proportion (%) of Total IPSS Responders (3 points) Rate
- Total IPSS (International Prostate Symptoms Score) Score at [ Time Frame: 6 months ]Change from Baseline to Month 6 in Total IPSS Score
- Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score [ Time Frame: 6 months ]Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score
- Total SHIM (Sexual Health Inventory for Men ) Score [ Time Frame: 6 months ]Change from Baseline to Month 6 in Total SHIM Score
- Total ISI (Incontinence Severity Index ) Score [ Time Frame: 6 months ]Change from Baseline to Month 6 in Total ISI Score
- Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score [ Time Frame: 6 months ]Change from Baseline to Month 6 in Total EJ-MSHQ Score
- Total Flow [ Time Frame: 6 months ]Change from Baseline to Month 6 in Total Flow
- Total residual urine [ Time Frame: 6 months ]Change from Baseline to Month 6 in Total residual urine
- Total Satisfaction Rate [ Time Frame: 6 months ]Change from Baseline to Month 6 in Total Satisfaction Rate
- IPSS QoL (Quality Of Life) score [ Time Frame: 6 months ]Change from Baseline to Month 6 in IPSS QoL score
- Recovery Success Rate [ Time Frame: 1 month ]Quality of Recovery Success Rate
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Male with symptomatic BPH|
|Accepts Healthy Volunteers:||No|
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
• Obstructing median lobe or any other anatomical or physiological pathology that can interfere the device implantation as assessed by cystoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395522
|Sydney Adventist Hospital Clinical School of the University of Sydney|
|Hospital Center University De Bordeaux|
|Hôpital Privé des Côtes d'Armor|
|University Hospital Frankfurt|
|Medical center - University of Freiburg|
|AOU di Catanzaro|
|Azienda Ospedaliera Universitaria San Martino|
|Clínica CEMTRO Ventisquero la Condesa|
|Madrid, Spain, 42 28035|
|Cantonal Hospital St. Gallen|
|Saint Gallen, Switzerland|
|Principal Investigator:||Francesco Porpiglia, MD||San Orbessano|
|Responsible Party:||Medi-Tate Ltd.|
|Other Study ID Numbers:||
|First Posted:||January 10, 2018 Key Record Dates|
|Last Update Posted:||June 1, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|