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

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04165408
• Other study ID #: CMX-LF-2019-022
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: CMX Research
• Contact: Robert Orr, BSc
• Phone: 778-239-7140
• Email: rorr[@]life360innovations.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

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.

Locations

Country	Name	City	State
Canada	The Fe/Male Health Centres	Oakville	Ontario
Canada	Dr. Dean Elterman	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
CMX Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the safety of the Contino®	safety is characterized by the absence of complications	14 Months
Primary	To establish the clinical performance of the Contino®	Clinical performance is characterized by the ability to stop involuntary urine flow	14 Months
Primary	Change from baseline in the ICIQ-SF score	At Visit Days 30 and 60	14 Months
Primary	Change from baseline in the weight of the protective pads	At Visit Days 30 and 60	14 Months
Secondary	Level of ease of use inserting the Contino® from the Follow-up Questionnaire	Level of comfort measurement	14 Months
Secondary	Level of ease of use removing the Contino® from the Follow-up Questionnaire	Level of comfort measurement	14 Months
Secondary	Number of subjects with newly observed urinary function improvements	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	14 Months