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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 belowSelect...
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:Select...
I had surgery for prostate cancer less than 2 months ago.
Select...
I have not been treated for a narrowed urethra.
Select...
I have a history of severe incontinence not caused by physical activity.
Select...
I have bladder control issues due to nerve problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
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 moreSecondary 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot consistently put the Contino® into your own urethra and take it out.I had surgery for prostate cancer less than 2 months ago.The investigator has found evidence of problems with the sphincter muscle.I am fully active or can carry out light work.I have a urinary tract infection, as diagnosed by my doctor.Your diabetes is not well controlled, according to the doctor.I am not on blood thinners, except for low-dose aspirin as deemed okay by my doctor.I have not been treated for a narrowed urethra.You have a weakened immune system because of a disease or medications, according to the doctor.Your body mass index (BMI) is higher than 32, but you can still use the device according to the doctor's opinion.I have a history of severe incontinence not caused by physical activity.I need antibiotics before procedures due to a heart condition.I am a man aged 18 or older.I use 2 or more pads a day due to urinary incontinence.I have bladder control issues due to nerve problems.
Research Study Groups:
This trial has the following groups:- Group 1: Device Use
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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