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

Not Applicable

Suspended

• Conditions: Urinary Incontinence
• Interventions: Device: Contino

• Registration Number: NCT04165408
• Lead Sponsor: 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

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.

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-18
• Study Start: 2019-11-19
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 25

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Use	Contino	Only one arm

Primary Outcome Measures

Name	Time	Method
To establish the safety of the Contino®	14 Months	safety is characterized by the absence of complications
Change from baseline in the ICIQ-SF score	14 Months	At Visit Days 30 and 60
To establish the clinical performance of the Contino®	14 Months	Clinical performance is characterized by the ability to stop involuntary urine flow
Change from baseline in the weight of the protective pads	14 Months	At Visit Days 30 and 60

Secondary Outcome Measures

Name	Time	Method
Level of ease of use removing the Contino® from the Follow-up Questionnaire	14 Months	Level of comfort measurement
Number of subjects with newly observed urinary function improvements	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
Level of ease of use inserting the Contino® from the Follow-up Questionnaire	14 Months	Level of comfort measurement

Trial Locations

Locations (2)

The Fe/Male Health Centres; 🇨🇦 Oakville, Ontario, Canada

Dr. Dean Elterman; 🇨🇦 Toronto, Ontario, Canada