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

Urinary Incontinence Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605459
• Other study ID #: CMX-UR-2013-004
• Status: Completed
• Phase: N/A
• Start date: February 4, 2014
• Est. completion date: April 3, 2018

Study information

• Verified date: June 2020
• Source: CMX Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 3, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Device:
• Comfort Plug™

Locations

Country	Name	City	State
Canada	Southern Interior Medical Research	Kelowna	British Columbia
Canada	The Fe/Male Health Centres	Oakville	Ontario
Canada	643094 Ontario Inc.	Scarborough	Ontario
Canada	Dr. Dean Elterman Medicine Professional Corporation	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
CMX Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish safety of the Comfort Plug	Safety is characterized by the absence of complications and adverse events	30 days
Primary	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
Primary	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	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

External Links

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