Back to resultsTrial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT STUDY)
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Comfort Plug™
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Southern Interior Medical Research
- The Fe/Male Health Centres
- 643094 Ontario Inc.
- Dr. Dean Elterman Medicine Professional Corporation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Device use
Arm Description
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.
Outcomes
Primary Outcome Measures
To establish safety of the Comfort Plug
Safety is characterized by the absence of complications and adverse events
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.
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03605459
Brief Title
Trial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT 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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 4, 2014 (Actual)
Primary Completion Date
March 8, 2018 (Actual)
Study Completion Date
April 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMX Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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)
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.
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
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device use
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Comfort Plug™
Primary Outcome Measure Information:
Title
To establish safety of the Comfort Plug
Description
Safety is characterized by the absence of complications and adverse events
Time Frame
30 days
Title
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Description
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.
Time Frame
30 days
Title
Weight of protective pads
Description
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).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incontinence Quality of Life Questionnaire (I-QOL)
Description
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.
Time Frame
30 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Casey, MD
Organizational Affiliation
CMX Research
Official's Role
Study Director
Facility Information:
Facility Name
Southern Interior Medical Research
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W4V5
Country
Canada
Facility Name
The Fe/Male Health Centres
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H3P1
Country
Canada
Facility Name
643094 Ontario Inc.
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1S4V5
Country
Canada
Facility Name
Dr. Dean Elterman Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://cuaj.ca/index.php/journal/article/view/6732/4463
Description
Abstract from the CUAJ June 2020 (page S59 & S60)
Learn more about this trial
Trial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT STUDY)
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