Status:
UNKNOWN
Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH
Lead Sponsor:
Medi-Tate Ltd.
Conditions:
BPH
Eligibility:
MALE
18+ years
Phase:
NA
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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT03395522
Start Date
February 18 2018
End Date
April 25 2025
Last Update
October 23 2023
Active Locations (12)
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1
Sydney Adventist Hospital Clinical School of the University of Sydney
Sydney, Australia
2
Hospital Center University De Bordeaux
Bordeaux, France
3
Hôpital Cochin
Paris, France
4
Hôpital Privé des Côtes d'Armor
Plérin, France