TerminatedNot Applicable

Study to Assess the Efficacy, Safety and Tolerability of (iTind)

Stopped: Due to the COVID-19 outbreak and the overall low recruitment

United Kingdom5 participantsStarted 2018-02-27

Plain-language 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 duration will be 12 months post implantation, with follow-up extension of up to 3 years. Extension of follow up period will not require an additional ICF.

Who can participate

Age range

40 Years – 90 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ability to void without catheter

Timeframe: 2 weeks

Trial details

NCT IDNCT03239951

SponsorMedi-Tate Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-20

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