Trial to Assess the Efficacy of the Comfort Plug™in Preventing 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)

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 Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: Comfort Plug™

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W4V5
      • Southern Interior Medical Research
  • Ontario
    • Oakville, Ontario, Canada, L6H3P1
      • The Fe/Male Health Centres
    • Scarborough, Ontario, Canada, M1S4V5
      • 643094 Ontario Inc.
    • Toronto, Ontario, Canada, M5T2S8
      • Dr. Dean Elterman Medicine Professional Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Male 18 years of age or older
2. At least 6 months post radical prostatectomy for localized prostate cancer
3. Cystoscopic evaluation of the lower urinary tract within 12 months of screening
4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status
5. Evidence of moderate to severe urinary incontinence as assessed by the investigator, requiring protective garments or pads
6. Post-surgical Prostate Specific Antigen (PSA) <0.04

Exclusion Criteria:

1. Inability to insert the Comfort Plug™ into his own urethra and remove it
2. History of significant incontinence prior to radical prostatectomy
3. Evidence of incomplete bladder emptying post radical prostatectomy
4. Recurrent , refractory bacteruria
5. Urethral stricture disease.
6. History of meatal stenosis or phimosis
7. History of any other malignancy except basal cell skin cancer
8. Planned radiotherapy for post prostatectomy residual disease within the next 90 days
9. Evidence of neurogenic bladder dysfunction
10. Multiple sclerosis or previous spinal cord trauma/pathology resulting in any neurologic deficit that, in the opinion of the investigator, might compromise the outcome
11. Ongoing constipation
12. Use of anticoagulant or antiplatelet medications excluding low-dose Acetylsalicylic acid (ASA)
13. Hemophilia
14. Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanical valve
15. Currently receiving successful medical treatment for incontinence.
16. The usage of male urethral slings
17. Planning to travel by airplane during the course of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device use; 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.	Device: Comfort Plug™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To establish safety of the Comfort Plug	Safety is characterized by the absence of complications and adverse events	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.	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).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: CMX Research

Publications and helpful links

Helpful Links

• Abstract from the CUAJ June 2020 (page S59 & S60)

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2014
• Primary Completion (ACTUAL): March 8, 2018
• Study Completion (ACTUAL): April 3, 2018

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (ACTUAL): July 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: CMX-UR-2013-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED