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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03395522




Registration number
NCT03395522
Ethics application status
Date submitted
26/12/2017
Date registered
10/01/2018
Date last updated
23/10/2023

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
Timepoint [1] 0 0
at Month 6 Visit
Secondary outcome [1] 0 0
Total IPSS (International Prostate Symptoms Score) Score at
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Total SHIM (Sexual Health Inventory for Men ) Score
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Total ISI (Incontinence Severity Index ) Score
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Total Flow
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Total residual urine
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Total Satisfaction Rate
Timepoint [8] 0 0
6 months
Secondary outcome [9] 0 0
IPSS QoL (Quality Of Life) score
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
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
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/04/2025
Actual
Sample size
Target
Accrual to date
Final
149
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
France
State/province [1] 0 0
Bordeaux
Country [2] 0 0
France
State/province [2] 0 0
Paris
Country [3] 0 0
France
State/province [3] 0 0
Plérin
Country [4] 0 0
Germany
State/province [4] 0 0
Frankfurt
Country [5] 0 0
Germany
State/province [5] 0 0
Freiburg
Country [6] 0 0
Italy
State/province [6] 0 0
Catanzaro
Country [7] 0 0
Italy
State/province [7] 0 0
Genova
Country [8] 0 0
Italy
State/province [8] 0 0
Rome
Country [9] 0 0
Italy
State/province [9] 0 0
Turin
Country [10] 0 0
Spain
State/province [10] 0 0
Madrid
Country [11] 0 0
Switzerland
State/province [11] 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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03395522