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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165408
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
CMX Research

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

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: Contino Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Device Use
Only one arm
Device: Contino
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.




Primary Outcome Measures :
  1. To establish the safety of the Contino® [ Time Frame: 14 Months ]
    safety is characterized by the absence of complications

  2. To establish the clinical performance of the Contino® [ Time Frame: 14 Months ]
    Clinical performance is characterized by the ability to stop involuntary urine flow

  3. Change from baseline in the ICIQ-SF score [ Time Frame: 14 Months ]
    At Visit Days 30 and 60

  4. Change from baseline in the weight of the protective pads [ Time Frame: 14 Months ]
    At Visit Days 30 and 60


Secondary Outcome Measures :
  1. Level of ease of use inserting the Contino® from the Follow-up Questionnaire [ Time Frame: 14 Months ]
    Level of comfort measurement

  2. Level of ease of use removing the Contino® from the Follow-up Questionnaire [ Time Frame: 14 Months ]
    Level of comfort measurement

  3. Number of subjects with newly observed urinary function improvements [ Time Frame: 14 Months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male 18 years of age or older
  2. Evidence of sphincteric incompetence as assessed by the Investigator
  3. ECOG 0 or 1 performance status
  4. Evidence of moderate to severe urinary incontinence as assessed by the Investigator, typically 2 or more protective garments or pads per day

Exclusion Criteria:

  1. Inability to consistently insert the Contino® into his own urethra and remove it
  2. Less than 2 months post radical prostatectomy for localized prostate cancer
  3. History of significant incontinence that is other than stress incontinence
  4. Evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions
  5. Untreated urethral stricture disease
  6. Use of anticoagulant or antiplatelet medications excluding low-dose ASA (in the opinion of the Investigator)
  7. Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve (in the opinion of the Investigator)
  8. 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)
  9. Known immune deficiency either due to disease or medications (in the opinion of the Investigator)
  10. Uncontrolled diabetes (in the opinion of the Investigator)
  11. An UTI (in the opinion of the Investigator)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165408


Locations
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Canada, Ontario
Dr. Dean Elterman Recruiting
Toronto, Ontario, Canada, M5G 1E2
Contact: Iris Chan    416-603-5800 ext 5033    Iris.Chan2@uhn.ca   
Sponsors and Collaborators
CMX Research

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Responsible Party: CMX Research
ClinicalTrials.gov Identifier: NCT04165408    
Other Study ID Numbers: CMX-LF-2019-022
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders