Trial to Assess the Efficacy of the Comfort Plug™in Preventing Urinary Incontinence (COMFORT STUDY)

Study Overview
=================
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.

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)

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Comfort Plug™


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device use<br>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™<br> <br> |

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 |