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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03395522




Registration number
NCT03395522
Ethics application status
Date submitted
26/12/2017
Date registered
10/01/2018
Date last updated
2/09/2020

Titles & IDs
Public title
Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH
Scientific 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)
Secondary ID [1] 0 0
MT-06
Universal Trial Number (UTN)
Trial acronym
MT-06
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BPH 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - iTind

Experimental: Device - ITind device implant


Treatment: Devices: iTind
device implanted for 5-7 days

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IPSS (International Prostate Symptoms Score) Responders Rate - the Proportion (%) of Total IPSS Responders (3 points) Rate
Timepoint [1] 0 0
at Month 6 Visit
Secondary outcome [1] 0 0
Total IPSS (International Prostate Symptoms Score) Score at - Change from Baseline to Month 6 in Total IPSS Score
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score - Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Total SHIM (Sexual Health Inventory for Men ) Score - Change from Baseline to Month 6 in Total SHIM Score
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Total ISI (Incontinence Severity Index ) Score - Change from Baseline to Month 6 in Total ISI Score
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score - Change from Baseline to Month 6 in Total EJ-MSHQ Score
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Total Flow - Change from Baseline to Month 6 in Total Flow
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Total residual urine - Change from Baseline to Month 6 in Total residual urine
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Total Satisfaction Rate - Change from Baseline to Month 6 in Total Satisfaction Rate
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
IPSS QoL (Quality Of Life) score - Change from Baseline to Month 6 in IPSS QoL score
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Recovery Success Rate - Quality of Recovery Success Rate
Timepoint [10] 0 0
1 month

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Adventist Hospital Clinical School of the University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
France
State/province [2] 0 0
Bordeaux
Country [3] 0 0
France
State/province [3] 0 0
Paris
Country [4] 0 0
France
State/province [4] 0 0
Plérin
Country [5] 0 0
Germany
State/province [5] 0 0
Frankfurt
Country [6] 0 0
Germany
State/province [6] 0 0
Freiburg
Country [7] 0 0
Germany
State/province [7] 0 0
Hamburg
Country [8] 0 0
Italy
State/province [8] 0 0
Catanzaro
Country [9] 0 0
Italy
State/province [9] 0 0
Genova
Country [10] 0 0
Italy
State/province [10] 0 0
Rome
Country [11] 0 0
Italy
State/province [11] 0 0
Turin
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid
Country [13] 0 0
Switzerland
State/province [13] 0 0
Frauenfeld
Country [14] 0 0
Switzerland
State/province [14] 0 0
Saint Gallen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medi-Tate Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03395522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Francesco Porpiglia, MD
Address 0 0
San Orbessano
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lihi Liviatan
Address 0 0
Country 0 0
Phone 0 0
972543114797
Fax 0 0
Email 0 0
lihi@medi-tate.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03395522