Clinical trial NCT03605459: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: CMX Research
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To establish safety of the Comfort Plug
timeFrame: 30 days
measure: International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: 30 days
measure: Weight of protective pads
timeFrame: 30 days
Secondary outcomes:
measure: Incontinence Quality of Life Questionnaire (I-QOL)
timeFrame: 30 days
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Southern Interior Medical Research
state: British Columbia
city: Oakville
country: Canada
facility: The Fe/Male Health Centres
state: Ontario
city: Scarborough
country: Canada
facility: 643094 Ontario Inc.
state: Ontario
city: Toronto
country: Canada
facility: Dr. Dean Elterman Medicine Professional Corporation
state: Ontario
Study officials:
affiliation: CMX Research
name: Richard Casey, MD
role: STUDY_DIRECTOR
References: