Urinary IncontinenceNCT04165408
Trial to Assess the Safety and Clinical Performance of Contino® in Preventing Urinary Incontinence
A study testing Contino in people with Urinary Incontinence, run by CMX Research at 2 sites in Canada.
Trial summary
This trial is to assess the safety and clinical performance of Contino device is preventing Urinary Incontinence in male subjects with Sphincteric Incompetence Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Contino
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Nov 2019to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1
Dr. Dean Elterman
Toronto, Ontario, M5G 1E2
About this study
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
This trial is to assess the safety and clinical performance of Contino device is preventing Urinary Incontinence in male subjects with Sphincteric Incompetence
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- Contino
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContinoDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device Use | Experimental | Only one arm Receives: Device: Contino |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the safety of the Contino®
safety is characterized by the absence of complications
Measured: 14 Months
To establish the clinical performance of the Contino®
Clinical performance is characterized by the ability to stop involuntary urine flow
Measured: 14 Months
Change from baseline in the ICIQ-SF score
At Visit Days 30 and 60
Measured: 14 Months
Change from baseline in the weight of the protective pads
At Visit Days 30 and 60
Measured: 14 Months
Secondary outcomes (3)
Level of ease of use inserting the Contino® from the Follow-up Questionnaire
Level of comfort measurement
Measured: 14 Months
Level of ease of use removing the Contino® from the Follow-up Questionnaire
Level of comfort measurement
Measured: 14 Months
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
Measured: 14 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start19 Nov 2019
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: One site still open but on hold due to financial issues. Enrollment will resume once payments are started up again. Other sites closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMX Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean Elterman, MD, Principal investigator, University Urology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165408
- Sponsor's protocol ID
- CMX-LF-2019-022
- Status last verified
- Aug 2024
- First submitted
- 1 Nov 2019
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04165408
- Acronym / sponsor ID
- CMX-LF-2019-022
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: One site still open but on hold due to financial issues. Enrollment will resume once payments are started up again. Other sites closed.
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- CMX ResearchUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Use | Experimental | Device: ContinoOnly one arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ContinoThe 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. | Device | Device Use |
Primary outcome
To establish the safety of the Contino®
Time frame: 14 Months
safety is characterized by the absence of complications
To establish the clinical performance of the Contino®
Time frame: 14 Months
Clinical performance is characterized by the ability to stop involuntary urine flow
Change from baseline in the ICIQ-SF score
Time frame: 14 Months
At Visit Days 30 and 60
Change from baseline in the weight of the protective pads
Time frame: 14 Months
At Visit Days 30 and 60
3 secondary outcomes
Level of ease of use inserting the Contino® from the Follow-up Questionnaire
Time frame: 14 Months
Level of ease of use removing the Contino® from the Follow-up Questionnaire
Time frame: 14 Months
Number of subjects with newly observed urinary function improvements
Time frame: 14 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean Elterman, MD principal investigator
University Urology Associates
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contino in people with Urinary Incontinence, run by CMX Research at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the safety of the Contino® (time frame: 14 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.