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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
149
device implanted for 5-7 days
Sydney Adventist Hospital Clinical School of the University of Sydney
Sydney, Australia
Hospital Center University De Bordeaux
Bordeaux, France
Hôpital Cochin
Paris, France
IPSS (International Prostate Symptoms Score) Responders Rate
the Proportion (%) of Total IPSS Responders (3 points) Rate
Time frame: at Month 6 Visit
Total IPSS (International Prostate Symptoms Score) Score at
Change from Baseline to Month 6 in Total IPSS Score
Time frame: 6 months
Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score
Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score
Time frame: 6 months
Total SHIM (Sexual Health Inventory for Men ) Score
Change from Baseline to Month 6 in Total SHIM Score
Time frame: 6 months
Total ISI (Incontinence Severity Index ) Score
Change from Baseline to Month 6 in Total ISI Score
Time frame: 6 months
Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score
Change from Baseline to Month 6 in Total EJ-MSHQ Score
Time frame: 6 months
Total Flow
Change from Baseline to Month 6 in Total Flow
Time frame: 6 months
Total residual urine
Change from Baseline to Month 6 in Total residual urine
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hôpital Privé des Côtes d'Armor
Plérin, France
University Hospital Frankfurt
Frankfurt, Germany
Medical center - University of Freiburg
Freiburg im Breisgau, Germany
AOU di Catanzaro
Catanzaro, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Italy
San'Andrea Hospital
Rome, Italy
San Orbessano
Turin, Italy
...and 2 more locations
Total Satisfaction Rate
Change from Baseline to Month 6 in Total Satisfaction Rate
Time frame: 6 months
IPSS QoL (Quality Of Life) score
Change from Baseline to Month 6 in IPSS QoL score
Time frame: 6 months
Recovery Success Rate
Quality of Recovery Success Rate
Time frame: 1 month