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

Primary Purpose

Urinary Incontinence

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Contino

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male 18 years of age or older
Evidence of sphincteric incompetence as assessed by the Investigator
ECOG 0 or 1 performance status
Evidence of moderate to severe urinary incontinence as assessed by the Investigator, typically 2 or more protective garments or pads per day

Exclusion Criteria:

Inability to consistently insert the Contino® into his own urethra and remove it
Less than 2 months post radical prostatectomy for localized prostate cancer
History of significant incontinence that is other than stress incontinence
Evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions
Untreated urethral stricture disease
Use of anticoagulant or antiplatelet medications excluding low-dose ASA (in the opinion of the Investigator)
Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve (in the opinion of the Investigator)
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)
Known immune deficiency either due to disease or medications (in the opinion of the Investigator)
Uncontrolled diabetes (in the opinion of the Investigator)
An UTI (in the opinion of the Investigator)

Sites / Locations

The Fe/Male Health CentresRecruiting
Dr. Dean EltermanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device Use

Arm Description

Only one arm

Outcomes

Primary Outcome Measures

To establish the safety of the Contino®

safety is characterized by the absence of complications

To establish the clinical performance of the Contino®

Clinical performance is characterized by the ability to stop involuntary urine flow

Change from baseline in the ICIQ-SF score

At Visit Days 30 and 60

Change from baseline in the weight of the protective pads

At Visit Days 30 and 60

Secondary Outcome Measures

Level of ease of use inserting the Contino® from the Follow-up Questionnaire

Level of comfort measurement

Level of ease of use removing the Contino® from the Follow-up Questionnaire

Level of comfort measurement

Number of subjects with newly observed urinary function improvements

including (but not limited to): being able to urinate independently for the first time since prostate surgery, return of urge to void and sensation of full bladder, better urinary stream, reduced time urinating from the follow up questionnaire

Full Information

NCT ID

NCT04165408

First Posted

November 1, 2019

Last Updated

July 24, 2023

Sponsor

CMX Research

1. Study Identification

Unique Protocol Identification Number

NCT04165408

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 19, 2019 (Actual)

Primary Completion Date

June 1, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CMX Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Device Use

Arm Type

Experimental

Arm Description

Only one arm

Intervention Type

Device

Intervention Name(s)

Contino

Intervention Description

The Contino® urethral insert is a self-administered licensed medical device, is inserted into the distal portion of the male urethra inhibiting the flow of urine. The Contino is self-inserted into the adult male urethra and is removed prior to urination. Much more than just a device, Contino® is an integrated solution that includes personalised fitting and support from incontinence specialists. It is made from highly specialised medical grade polymer, which has been extensively tested for biocompatibility.

Primary Outcome Measure Information:

Title

To establish the safety of the Contino®

Description

safety is characterized by the absence of complications

Time Frame

14 Months

Title

To establish the clinical performance of the Contino®

Description

Clinical performance is characterized by the ability to stop involuntary urine flow

Time Frame

14 Months

Title

Change from baseline in the ICIQ-SF score

Description

At Visit Days 30 and 60

Time Frame

14 Months

Title

Change from baseline in the weight of the protective pads

Description

At Visit Days 30 and 60

Time Frame

14 Months

Secondary Outcome Measure Information:

Title

Level of ease of use inserting the Contino® from the Follow-up Questionnaire

Description

Level of comfort measurement

Time Frame

14 Months

Title

Level of ease of use removing the Contino® from the Follow-up Questionnaire

Description

Level of comfort measurement

Time Frame

14 Months

Title

Number of subjects with newly observed urinary function improvements

Description

Time Frame

14 Months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male 18 years of age or older Evidence of sphincteric incompetence as assessed by the Investigator ECOG 0 or 1 performance status Evidence of moderate to severe urinary incontinence as assessed by the Investigator, typically 2 or more protective garments or pads per day Exclusion Criteria: Inability to consistently insert the Contino® into his own urethra and remove it Less than 2 months post radical prostatectomy for localized prostate cancer History of significant incontinence that is other than stress incontinence Evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions Untreated urethral stricture disease Use of anticoagulant or antiplatelet medications excluding low-dose ASA (in the opinion of the Investigator) Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve (in the opinion of the Investigator) 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) Known immune deficiency either due to disease or medications (in the opinion of the Investigator) Uncontrolled diabetes (in the opinion of the Investigator) An UTI (in the opinion of the Investigator)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Orr, BSc

Phone

778-239-7140

rorr@life360innovations.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nada Dragicevic, MBA, PMP

Phone

9053381078

Ext

226

ndragicevic@cmxres.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dean Elterman, MD

Organizational Affiliation

University Urology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Fe/Male Health Centres

City

Oakville

State/Province

Ontario

ZIP/Postal Code

L6H 3P1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rupi Dhaliwal, RN

Phone

905-338-3130

Ext

236

rdhaliwal@malehealth.com

First Name & Middle Initial & Last Name & Degree

Peter Incze, MD

First Name & Middle Initial & Last Name & Degree

Richard Casey, MD

Facility Name

Dr. Dean Elterman

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1E2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Iris Chan

Phone

416-603-5800

Ext

5033

Iris.Chan2@uhn.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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