Interventional procedure overview of prostatic urethral temporary implant insertion for lower urinary tract symptoms caused by benign prostatic hyperplasia
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Additional information considered by IPAC
Professional experts' opinions
Expert advice was sought from consultants who have been nominated or ratified by their professional Society or Royal College. The advice received is their individual opinion and is not intended to represent the view of the society. The advice provided by professional experts, in the form of the completed questionnaires, is normally published in full on the NICE website during public consultation, except in circumstances but not limited to, where comments are considered voluminous, or publication would be unlawful or inappropriate.
One professional expert questionnaire for prostatic urethral temporary implant insertion for LUTS caused by BPH was submitted and can be found on the NICE website.
Patient commentators' opinions
NICE's Public Involvement Programme will send questionnaires to NHS trusts for distribution to patients who had the procedure (or their carers). When NICE has received the completed questionnaires, these will be discussed by the committee.
Company engagement
A structured information request was sent to 1 company who manufactures a potentially relevant device for use in this procedure. NICE received 1 completed submission. This was considered by the IP team and any relevant points have been taken into consideration when preparing this overview.
Issues for consideration by IPAC
Ongoing trials:
A Post Market Prospective, Randomized, Controlled, Multi-center International Study to Assess the Safety of the iTind Compared to TURP in Subjects With Symptomatic BPH (NCT04757116); randomised controlled trial; n=140; estimated study completion date October 2023.
One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH), (MT-06; NCT03395522); Australia, Austria, France, Germany, Italy, Spain Switzerland; single group assignment; n=200; estimated study completion date October 2021.
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