Clinical trial NCT04165408: Trial to Assess the Safety and Clinical Performance of Contino® in Preventing Urinary Incontinence
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: CMX Research
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: To establish the safety of the Contino®
timeFrame: 14 Months
measure: To establish the clinical performance of the Contino®
timeFrame: 14 Months
measure: Change from baseline in the ICIQ-SF score
timeFrame: 14 Months
measure: Change from baseline in the weight of the protective pads
timeFrame: 14 Months
Secondary outcomes:
measure: Level of ease of use inserting the Contino® from the Follow-up Questionnaire
timeFrame: 14 Months
measure: Level of ease of use removing the Contino® from the Follow-up Questionnaire
timeFrame: 14 Months
measure: Number of subjects with newly observed urinary function improvements
timeFrame: 14 Months
Other outcomes:
Locations:
city: Oakville
country: Canada
facility: The Fe/Male Health Centres
state: Ontario
city: Toronto
country: Canada
facility: Dr. Dean Elterman
state: Ontario
Study officials:
affiliation: University Urology Associates
name: Dean Elterman, MD
role: PRINCIPAL_INVESTIGATOR
References: