Status:
TERMINATED
Study to Assess the Efficacy, Safety and Tolerability of (iTind)
Lead Sponsor:
Medi-Tate Ltd.
Conditions:
BPH
Eligibility:
MALE
40-90 years
Phase:
NA
Brief Summary
Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria. A total of 50 eligible subjects will be recruited into the study to receive treatment with iTind system. Study durat...
Detailed Description
Spontaneous acute urinary retention (AUR) is one of the most significant complications of long-term benign prostatic hyperplasia (BPH). In the past it has represented an immediate indication for surge...
Eligibility Criteria
Inclusion
- Male with AUR secondary to BPO
- Age ≥40 years
- Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker
- Ability to sign an informed consent form
- Prostate volume \<80 ml
- Life expectancy \>1 year.
Exclusion
- Suspected malignant disease of the lower urinary tract including prostate or bladder cancer
- Chronic retention of urine with history of either retention volume greater than one liter or upper tract obstruction
- Known neurogenic bladder
- Immunosuppression
- Suspected urethral strictures, bladder neck contracture, Urinary bladder stones
- An obstructive or protruding median lobe of the prostate
- An active symptomatic urinary tract infection
- Enrolled in another treatment trial for any disease
- Previous pelvic irradiation or radical pelvic surgery
- Any previous prostate surgery.
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03239951
Start Date
February 27 2018
End Date
March 31 2020
Last Update
July 22 2020
Active Locations (3)
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1
Firmly Park Hospital
Frimley, United Kingdom
2
King's college
London, United Kingdom, SE1 9RT
3
Norwich University Hospital
Norwich, United Kingdom