Sphincteric incompetence in adult males Urological and Genital Diseases Other specified urinary incontinence
Conditions
Interventions
Only incontinent men with sphincteric incompetence, including those who have undergone radical prostatectomy, will be screened. All subjects who meet entry criteria will receive Comfort Plug™ instruct
Sponsors
Life360 Innovations Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 18 years of age or older 2. Evidence of sphincteric incompetence as assessed by the Investigator 3. Cystoscopic evaluation of the lower urinary tract within 24 months of screening 4. 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 PSA < 5 ng/ml
Exclusion criteria
Exclusion criteria: 1. Inability to insert the Comfort Plug™ into his own urethra and remove it 2. Less than 6 months post radical prostatectomy for localized prostate cancer 3. History of significant incontinence prior to radical prostatectomy 4. Evidence of neurogenic bladder dysfunction resulting in uncontrolled contractions 5. Untreated urethral stricture disease 6. History of meatal stenosis or phimosis 7. Use of anticoagulant or antiplatelet medications excluding low-dose ASA 8. Any cardiac condition that requires the use of pre-procedure antibiotic prophylaxis such as a mechanic valve 9. Body Mass Index (BMI) greater than 32 kg/m2 10. Known immune deficiency either due to disease or medications 11. Uncontrolled diabetes (in the opinion of the Investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effectiveness as measured with the ICIQ-SF score at baseline (Visit Day 0) and Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts) 2. Effectiveness as measured by incontinence pad weight at baseline (Visit Day 0) and at Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts) 3. Adverse events collected at each telephone contact and visit to the clinical facility 4. Clinical and laboratory data including physical examinations and vital signs at at Visit Day 0 and Visit Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life assessed by the Incontinence Quality of Life (I-QOL) Instrument at baseline and Visit Days 7 and 30 (cohort 1) or Visit Days 14 and 30 (subsequent cohorts) for: 1.1. Avoidance and Limiting Behaviour 1.2. Psychosocial Impacts 1.3. Social Embarrassment 2. Number of subjects who discontinue use of the Comfort Plug™ due to lack of comfort 3. Number of subjects that would continue using the Comfort Plug™ if given the opportunity, assessed using the Follow-up Questionnaire 4. Level of ease of use inserting the Comfort Plug™, assessed using the Follow-up Questionnaire 5. Level of ease of use removing the Comfort Plug™, assessed using the Follow-up Questionnaire 6. Level of satisfaction with the Comfort Plug™, assessed using the Follow-up Questionnaire 7. Number of subjects with newly observed urinary function improvements, including (but not limited to): being able to urinate independently for the first time since prostate surgery, return of urge to void and sensation of full bladder, better urinary stream, reduced time urinating, assessed using the Follow-up Questionnaire The subjects complete the activity of the trial at day 30 and there is a close out period of the study that takes place over the next 30 days (Follow-up Questionnaire, blood work, health examination by the doc., return of materials, etc.). At day 56 +/- 3 days a study nurse contacts the subject to confirm that everything is completed and the subject is still in good health. | — |
Countries
Canada
Contacts
Public ContactRobert Orr
Outcome results
None listed