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

NCT ID: NCT04165408

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-19
• Study Completion Date: 2025-12-30

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Use

Only one arm

Group Type: EXPERIMENTAL

Contino

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

CMX Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean Elterman, MD

Role: PRINCIPAL_INVESTIGATOR

University Urology Associates

Locations

The Fe/Male Health Centres

Oakville, Ontario, Canada

Dr. Dean Elterman

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CMX-LF-2019-022

Identifier Type: -

Identifier Source: org_study_id