NCT04165408

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: CMX Research · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-19
• Primary completion: 2025-09-01
• Completion: 2025-12-30
• First posted: 2019-11-18
• Last updated: 2025-02-20

Locations

2 sites across 1 country: Canada