Urinary IncontinenceNCT03605459
Trial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT STUDY)
A study testing Comfort Plug™ in people with Urinary Incontinence, run by CMX Research at 4 sites in Canada.
Trial summary
Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects with Post Prostatectomy Urinary Incontinence (COMFORT STUDY) 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?
- Comfort Plug™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesCanada
- Study dates
- 4 Feb 2014to 3 Apr 2018
- 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
- At least 6 months post radical prostatectomy for localized prostate cancer
- Cystoscopic evaluation of the lower urinary tract within 12 months of screening
- Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status
- Evidence of moderate to severe urinary incontinence as assessed by the investigator, requiring protective garments or pads
- Post-surgical Prostate Specific Antigen (PSA) <0.04
Who cannot join
- Inability to insert the Comfort Plug™ into his own urethra and remove it
- History of significant incontinence prior to radical prostatectomy
- Evidence of incomplete bladder emptying post radical prostatectomy
- Recurrent , refractory bacteruria
- Urethral stricture disease.
- History of meatal stenosis or phimosis
Show all 17Show fewer
- History of any other malignancy except basal cell skin cancer
- Planned radiotherapy for post prostatectomy residual disease within the next 90 days
- Evidence of neurogenic bladder dysfunction
- Multiple sclerosis or previous spinal cord trauma/pathology resulting in any neurologic deficit that, in the opinion of the investigator, might compromise the outcome
- Ongoing constipation
- Use of anticoagulant or antiplatelet medications excluding low-dose Acetylsalicylic acid (ASA)
- Hemophilia
- Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve
- Currently receiving successful medical treatment for incontinence.
- The usage of male urethral slings
- Planning to travel by airplane during the course of the study
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Southern Interior Medical Research
Kelowna, British Columbia, V1W4V5
The Fe/Male Health Centres
Oakville, Ontario, L6H3P1
643094 Ontario Inc.
Scarborough Village, Ontario, M1S4V5
Dr. Dean Elterman Medicine Professional Corporation
Toronto, Ontario, M5T2S8
About this study
Official title: Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects With Post Prostatectomy Urinary Incontinence (COMFORT STUDY)
Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects with Post Prostatectomy Urinary Incontinence (COMFORT STUDY)
Read the detailed description
This is a first-in-human, device assessment, feasibility study to assess the safety, effectiveness, comfort and usability of the prototype Comfort Plug™ for controlling urinary incontinence in male subjects. No drug treatment will be administered.
- Conditions
- Urinary Incontinence
- Being tested
- Comfort Plug™
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort Plug™Device
| Study group | Role | What they receive |
|---|---|---|
| Device use | Experimental | Only one treatment arm; the "Comfort Plug™" is a device designed to control urinary incontinence in male subjects by being placed in the urethra to stop urine leakage. Receives: Device: Comfort Plug™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish safety of the Comfort Plug
Safety is characterized by the absence of complications and adverse events
Measured: 30 days
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
The ICIQ is a psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact of urinary incontinence (UI) on Quality of Life in men and women. The ICIQ-SF is scored from 0 to 21, with greater scores indicating increased severity of UI. The change from baseline (Visit Day 0) in the ICIQ-SF score at Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts) will be examined.
Measured: 30 days
Weight of protective pads
Change from baseline (Visit Day 0) in the weight of the protective pads a Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts).
Measured: 30 days
Secondary outcomes (1)
Incontinence Quality of Life Questionnaire (I-QOL)
The questionnaire has a scale of 22-110; The higher the score, the less incontinence is having a negative impact on the subject's Quality of Life. Change from baseline (Visit Day 0) in the I-QOL instrument scores at Visit Days 14 and 30 for i) avoidance and limiting behavior ii) psychosocial impacts iii) social embarrassment will be examined.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start4 Feb 2014
- Primary completion8 Mar 2018
- Study completion3 Apr 2018
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMX Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Casey, MD, Study director, CMX Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605459
- Sponsor's protocol ID
- CMX-UR-2013-004
- Status last verified
- Jun 2020
- First submitted
- 7 Feb 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects With Post Prostatectomy Urinary Incontinence (COMFORT STUDY)
- ClinicalTrials.gov ID
- NCT03605459
- Acronym / sponsor ID
- CMX-UR-2013-004
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CMX ResearchUniversity, hospital or other
- Study start
- 4 Feb 2014 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 30 Jul 2018 (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.
Validation Study: A Prospective, Non-Randomized, Single Arm Trial to Assess the Efficacy of the Comfort Plug™ in Preventing Urinary Incontinence in Male Subjects with Post Prostatectomy Urinary Incontinence (COMFORT STUDY)
Detailed description
This is a first-in-human, device assessment, feasibility study to assess the safety, effectiveness, comfort and usability of the prototype Comfort Plug™ for controlling urinary incontinence in male subjects. 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: Comfort Plug™Only one treatment arm; the "Comfort Plug™" is a device designed to control urinary incontinence in male subjects by being placed in the urethra to stop urine leakage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male 18 years of age or older
- At least 6 months post radical prostatectomy for localized prostate cancer
- Cystoscopic evaluation of the lower urinary tract within 12 months of screening
- Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status
- Evidence of moderate to severe urinary incontinence as assessed by the investigator, requiring protective garments or pads
Key exclusion criteria (17 listed)
- Inability to insert the Comfort Plug™ into his own urethra and remove it
- History of significant incontinence prior to radical prostatectomy
- Evidence of incomplete bladder emptying post radical prostatectomy
- Recurrent , refractory bacteruria
- 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 |
|---|---|---|
| Comfort Plug™ | Device | Device use |
Primary outcome
To establish safety of the Comfort Plug
Time frame: 30 days
Safety is characterized by the absence of complications and adverse events
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Time frame: 30 days
The ICIQ is a psychometrically robust patient-completed questionnaire for evaluating the frequency, severity and impact of urinary incontinence (UI) on Quality of Life in men and women. The ICIQ-SF is scored from 0 to 21, with greater scores indicating increased severity of UI. The change from baseline (Visit Day 0) in the ICIQ-SF score at Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts) will be examined.
Weight of protective pads
Time frame: 30 days
Change from baseline (Visit Day 0) in the weight of the protective pads a Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts).
1 secondary outcome
Incontinence Quality of Life Questionnaire (I-QOL)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Abstract from the CUAJ June 2020 (page S59 \& S60)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Urinary Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
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.
Richard Casey, MD study director
CMX Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort Plug™ in people with Urinary Incontinence, run by CMX Research at 4 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 safety of the Comfort Plug (time frame: 30 days). The study lists 3 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 11 Jun 2020.