Trial to Assess the Safety and Clinical Performance of Contino® in Preventing Urinary Incontinence

Study Overview
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Brief Summary
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This trial is to assess the safety and clinical performance of Contino device is preventing Urinary Incontinence in male subjects with Sphincteric Incompetence

Detailed Description
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Sphincteric incompetence is most commonly found in men who have had radical prostatectomy (RP). RP is the most common treatment for localized high-risk Prostate Cancer in North America. The Contino®, a urethral insert, was conceived by a prostate cancer survivor and worn for 10+ years without incident, and a First in Human clinical trial was completed without serious adverse event. The basis for this clinical trial is a post market clinical follow-up study. No drug treatment will be administered.

Official Title
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A Prospective, Non-Randomized, Single Arm Trial to Assess the Safety and Clinical Performance of the Contino®, a Urethral Insert, in Preventing Urinary Incontinence in Male Subjects With Sphincteric Incompetence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Contino


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 18 years of age or older Evidence of sphincteric incompetence as assessed by the Investigator ECOG 0 or 1 performance status Evidence of moderate to severe urinary incontinence as assessed by the Investigator, typically 2 or more protective garments or pads per day Exclusion Criteria: Inability to consistently insert the Contino® into his own urethra and remove it Less than 2 months post radical prostatectomy for localized prostate cancer History of significant incontinence that is other than stress incontinence Evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions Untreated urethral stricture disease Use of anticoagulant or antiplatelet medications excluding low-dose ASA (in the opinion of the Investigator) Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve (in the opinion of the Investigator) Body Mass Index (BMI) greater than 32 kg/m2 (in the opinion of the Investigator provided the subject is able to insert & remove the device) Known immune deficiency either due to disease or medications (in the opinion of the Investigator) Uncontrolled diabetes (in the opinion of the Investigator) An UTI (in the opinion of the Investigator)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Use<br>Only one arm | Device: Contino<br>* The Contino® urethral insert is a self-administered licensed medical device, is inserted into the distal portion of the male urethra inhibiting the flow of urine. The Contino is self-inserted into the adult male urethra and is removed prior to urination. Much more than just a device, Contino® is an integrated solution that includes personalised fitting and support from incontinence specialists. It is made from highly specialised medical grade polymer, which has been extensively tested for biocompatibility.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the safety of the Contino® | safety is characterized by the absence of complications | 14 Months | 
| To establish the clinical performance of the Contino® | Clinical performance is characterized by the ability to stop involuntary urine flow | 14 Months | 
| Change from baseline in the ICIQ-SF score | At Visit Days 30 and 60 | 14 Months | 
| Change from baseline in the weight of the protective pads | At Visit Days 30 and 60 | 14 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of ease of use inserting the Contino® from the Follow-up Questionnaire | Level of comfort measurement | 14 Months | 
| Level of ease of use removing the Contino® from the Follow-up Questionnaire | Level of comfort measurement | 14 Months | 
| Number of subjects with newly observed urinary function improvements | including (but not limited to): being able to urinate independently for the first time since prostate surgery, return of urge to void and sensation of full bladder, better urinary stream, reduced time urinating from the follow up questionnaire | 14 Months |