Clinical trial NCT03395522: Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: BPH
Lead sponsor: Medi-Tate Ltd.
Sponsor class: INDUSTRY
First posted: 2018-01-10
Enrollment: 149
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: device group only
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: IPSS (International Prostate Symptoms Score) Responders Rate
timeFrame: at Month 6 Visit
Secondary outcomes:
measure: Total IPSS (International Prostate Symptoms Score) Score at
timeFrame: 6 months
measure: Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score
timeFrame: 6 months
measure: Total SHIM (Sexual Health Inventory for Men ) Score
timeFrame: 6 months
measure: Total ISI (Incontinence Severity Index ) Score
timeFrame: 6 months
measure: Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score
timeFrame: 6 months
measure: Total Flow
timeFrame: 6 months
measure: Total residual urine
timeFrame: 6 months
measure: Total Satisfaction Rate
timeFrame: 6 months
measure: IPSS QoL (Quality Of Life) score
timeFrame: 6 months
measure: Recovery Success Rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Adventist Hospital Clinical School of the University of Sydney
city: Bordeaux
country: France
facility: Hospital Center University De Bordeaux
city: Paris
country: France
facility: Hôpital Cochin
city: Plérin
country: France
facility: Hôpital Privé des Côtes d'Armor
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Freiburg
country: Germany
facility: Medical center - University of Freiburg
city: Catanzaro
country: Italy
facility: AOU di Catanzaro
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino
city: Rome
country: Italy
facility: San'Andrea Hospital
city: Turin
country: Italy
facility: San Orbessano
city: Madrid
country: Spain
facility: Clínica CEMTRO Ventisquero la Condesa
city: Saint Gallen
country: Switzerland
facility: Cantonal Hospital St. Gallen
Study officials:
affiliation: San Orbessano
name: Francesco Porpiglia, MD
role: PRINCIPAL_INVESTIGATOR
References: