BPH Clinical Trial - Study to Assess the Efficacy, Safety & Tolerability

Status Terminated

Clinical Trial 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.

Clinical Trial 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 surgery. Between 25% and 30% of men who underwent transurethral prostatectomy (TURP) had AUR as their main indication in older series and today most subjects failing to void after attempted catheter removal still undergo surgery. For this reason alone, AUR is an important and feared event from the viewpoint of the subject. The subject originally has inability to urinate, with increasing pain, and eventually a visit to the emergency room, catheterization, follow-up visits to the physicians, an attempt at catheter removal, and eventual recovery or surgery, which is both painful and time consuming.

After the acute period most men with AUR will be offered a 'trial without catheter' (TWOC) and about half will resume spontaneous voiding. Most men who fail a TWOC, experience a recurrent episode of AUR, or have moderate or severe lower urinary tract symptoms (LUTS) that are refractory to medical management will be considered for surgery.

In the older literature, the risk of recurrent AUR was cited as 56% to 64% within 1 week of the first episode and 76% to 83% in men with diagnosed BPH.

(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476058/). Additional researches show that ten percent of men in their seventies and 30% in their eighties will have AUR within the next five years.

Benign prostatic hyperplasia is the cause for the AUR in at least 65% of men presenting with AUR.

In the below study of the natural history of BPH, the risk of AUR was 1.6% at five years for men aged 40-49 years and 10% at 70-79 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03239951
Study type	Interventional
Source	Medi-Tate Ltd.
Contact
Status	Terminated
Phase	N/A
Start date	February 27, 2018
Completion date	March 31, 2020

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms