NCT03605459

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

4.1 years

First QC Date

February 7, 2014

Last Update Submit

June 9, 2020

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Incontinence Quality of Life Questionnaire (I-QOL)

    30 days

Study Arms (1)

Device use

EXPERIMENTAL

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™

Interventions

Comfort Plug™DEVICE
Device use

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Southern Interior Medical Research

Kelowna, British Columbia, V1W4V5, Canada

Location

The Fe/Male Health Centres

Oakville, Ontario, L6H3P1, Canada

Location

643094 Ontario Inc.

Scarborough Village, Ontario, M1S4V5, Canada

Location

Dr. Dean Elterman Medicine Professional Corporation

Toronto, Ontario, M5T2S8, Canada

Location

Related Links

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard Casey, MD

    CMX Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2014

First Posted

July 30, 2018

Study Start

February 4, 2014

Primary Completion

March 8, 2018

Study Completion

April 3, 2018

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

CA(4)