- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03239951
Study to Assess the Efficacy, Safety and Tolerability of (iTind)
One-arm, Controlled, Multi-Center Prospective Study to Assess the Efficacy, Safety and Tolerability of Medi-Tate Temporary Implantable Nitinol Device (iTind) in Subjects With Acute Urinary Retention Secondary to (BPO)
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.
Study Overview
Detailed 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Frimley, United Kingdom
- Firmly Park Hospital
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London, United Kingdom, SE1 9RT
- King's College
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Norwich, United Kingdom
- Norwich University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device
Temporary implant (iTind)
|
temporary implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ability to void without catheter
Time Frame: 2 weeks
|
TWOC Success Rate, defined as the proportion (%) of subjects successfully undergoing the TWOC assessment at the later of visit 3 or visit 4.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gordon Muir, MD, King's College Hospital NHS Trust
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MT-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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