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

    lihi@medi-tate.com

  • Clinicaltrials.gov Identifier

    NCT03239951

  • 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 involved

  • REC 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