Trial to Assess the Safety and Clinical Performance of Contino® in Preventing Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT04165408|
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Device: Contino||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Device Use
Only one arm
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.
- To establish the safety of the Contino® [ Time Frame: 14 Months ]safety is characterized by the absence of complications
- To establish the clinical performance of the Contino® [ Time Frame: 14 Months ]Clinical performance is characterized by the ability to stop involuntary urine flow
- Change from baseline in the ICIQ-SF score [ Time Frame: 14 Months ]At Visit Days 30 and 60
- Change from baseline in the weight of the protective pads [ Time Frame: 14 Months ]At Visit Days 30 and 60
- Level of ease of use inserting the Contino® from the Follow-up Questionnaire [ Time Frame: 14 Months ]Level of comfort measurement
- Level of ease of use removing the Contino® from the Follow-up Questionnaire [ Time Frame: 14 Months ]Level of comfort measurement
- 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
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
|Dr. Dean Elterman||Recruiting|
|Toronto, Ontario, Canada, M5G 1E2|
|Contact: Iris Chan 416-603-5800 ext 5033 Iris.Chan2@uhn.ca|