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Device

Contino Device for Urinary Incontinence

N/A
Recruiting
Led By Dean Elterman, MD
Research Sponsored by CMX Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG 0 or 1 performance status
Male 18 years of age or older
Must not have
Less than 2 months post radical prostatectomy for localized prostate cancer
Untreated urethral stricture disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
No Placebo-Only Group

Summary

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

Who is the study for?
This trial is for men over 18 with moderate to severe urinary incontinence, using at least two pads per day due to weak bladder muscles. Participants should be relatively healthy (ECOG status of 0 or 1). Men who can't self-insert the Contino device, had recent prostate surgery, have non-stress incontinence causes, untreated narrow urethra, immune issues, uncontrolled diabetes or UTI's, neurogenic bladder dysfunction, are on certain blood thinners or have a BMI over 32 may not qualify.
What is being tested?
The trial tests the safety and effectiveness of the Contino device in preventing urine leakage in men with weak bladder sphincter muscles. It aims to see if this device can reduce reliance on protective garments or pads.
What are the potential side effects?
Potential side effects might include discomfort during insertion/removal of the device, possible urinary tract infections from repeated use and irritation within the urethra where the device sits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am a man aged 18 or older.
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I use 2 or more pads a day due to urinary incontinence.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had surgery for prostate cancer less than 2 months ago.
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I have not been treated for a narrowed urethra.
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I have a history of severe incontinence not caused by physical activity.
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I have bladder control issues due to nerve problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the ICIQ-SF score
Change from baseline in the weight of the protective pads
To establish the clinical performance of the Contino®
+1 more
Secondary study objectives
Level of ease of use inserting the Contino® from the Follow-up Questionnaire
Level of ease of use removing the Contino® from the Follow-up Questionnaire
Number of subjects with newly observed urinary function improvements

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device UseExperimental Treatment1 Intervention
Only one arm

Find a Location

Who is running the clinical trial?

CMX ResearchLead Sponsor
10 Previous Clinical Trials
2,187 Total Patients Enrolled
1 Trials studying Urinary Incontinence
30 Patients Enrolled for Urinary Incontinence
Bob Orr, PEngStudy DirectorCEO - Life360
Dean Elterman, MDPrincipal InvestigatorUniversity Urology Associates

Media Library

Contino (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04165408 — N/A
Urinary Incontinence Research Study Groups: Device Use
Urinary Incontinence Clinical Trial 2023: Contino Highlights & Side Effects. Trial Name: NCT04165408 — N/A
Contino (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04165408 — N/A
~4 spots leftby Nov 2025
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