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

CMX Research

Status: Suspended

Conditions: Urinary Incontinence

Treatments: Device: Contino

Study type: Interventional

Funder types: Other

Identifiers

NCT04165408

CMX-LF-2019-022

Details and patient eligibility

About

This trial is to assess the safety and clinical performance of Contino device is preventing Urinary Incontinence in male subjects with Sphincteric Incompetence

Full 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.

Enrollment: 25 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Device Use

Experimental group

Description:

Only one arm

Treatment:

Device: Contino