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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies in this clinical trial to which prospective participants may apply?
"Clinicaltrials.gov reports that this medical trial is still enrolling participants, with the first post going live on November 19th 2019 and the most recent update occurring January 18th 2022."
Answered by AI
How many participants can join this clinical exploration?
"Affirmative. According to information accessible on clinicaltrials.gov, this clinical trial was first posted in November 2019 and the page was recently updated in January 2022. There is a need for up to 25 participants from 3 medical sites."
Answered by AI
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