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

  • STATUS
    Recruiting
  • days left to enroll
    87
  • participants needed
    25
  • sponsor
    CMX Research
Updated on 22 March 2022

Summary

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

Description

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.

Details
Condition Urinary Incontinence
Treatment Contino
Clinical Study IdentifierNCT04165408
SponsorCMX Research
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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