iTIND RCT
Research type
Research Study
Full title
Randomized, Controlled, Multi-Center, Prospective Study to Assess the Tolerability, Safety and Efficacy of Medi-Tate Temporary Implantable Nitinol Device (iTIND) in Subjects with Acute Urinary Retention Secondary to Benign Prostatic Obstruction (BPO)
IRAS ID
227378
Contact name
Lihi Liviatan
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Spontaneous acute urinary retention (AUR) is one of the most significant complications of long-term benign prostatic hyperplasia (BPH). AUR patients usually attend A&E or are referred to Urology with inability to pass urine, increasing discomfort or suprapubic pain. They are then catheterised and reviewed by a specialist nurse who perform a Trial Without the Catheter TWOC. The risk of recurrent AUR ranges between 56% and 64% within 1 week of the first episode and 76% to 83% in men with diagnosed BPH. Thus, after the first AUR, there is high risk of A&E attendance or multiple urological referrals severely impacting on patients’ quality of life and the economic resources.
Generally, patients who fail TWOCs are consented and put in waiting lists for dis-obstructing prostate surgery such as TURP or Laser prostatectomy which currently are the best therapeutic options but at the same time expensive and with long waiting list. Moreover, many frail patients are not eligible because of their comorbidities.
The primary objective of this Randomised clinical Trial (RCT) is to assess the efficacy of the MediTate iTind in subjects with AUR who fail the first TWOC, by improving the Catheter free success rate.
Will be considered eligible all patients who fulfil the following inclusion criteria
• Male with AUR secondary to BPH
• Age ≥40 years
• Non-responders to medical treatment:
• Subjects with one voiding trial failure (α-blocker consumption for at least 3 days prior to trial without catheter)
• Ability to sign an informed consent form
• Prostate volume < 80 ml
• Life expectancy >1 year.
• No active symptomatic urinary tract infection
Follow-up
Candidates will be followed-up for one year after the procedure
Sites
Up to 5 sites across the UK will be involvedREC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0610
Date of REC Opinion
4 Dec 2017
REC opinion
Further Information Favourable Opinion