Urinary Incontinence
Conditions
Keywords
urinary incontinence, Bulkamid
Brief summary
To assess effectiveness of Bulkamid® injection in females suffering from stress or mixed (stress and urge) urinary incontinence after 12 months follow up period
Interventions
DEVICEBulkamid
initial injection with option for second (if required)
Sponsors
Contura
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Symptomatic stress or mixed urinary incontinence for at least 12 months * Having at least 1 incontinence episode per day over three days
Exclusion criteria
* Regular or intermittent users of an urethral catheter * Pregnant women * Suffer from severe allergies or anaphylaxis * Suffer from autoimmune diseases or any unstable or sever cardio-vascular disease * History of any cancer within the last 5 years * Previous surgery for the treatment of urinary incontinence, including bulking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective responder rate after 12 months follow-up | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| ICIQ | Baseline, treatment, 1-, 6-, 12- and 24-months |
| 24 hour urine leakage | Baseline, treatment, 1-, 6-, 12- and 24-months |
| daily incidence of incontinence episodes | Baseline, treatment, 1-, 6-, 12- and 24-months |
| Qol | Baseline, treatment, 1-, 6-, 12- and 24-months |
Countries
Denmark, Finland, Germany, Sweden, United Kingdom
Outcome results
None listed