involuntary urine loss stress-incontinence
Conditions
Interventions
A onetime ultrasound-directed intramuscular and intraurethral injection of
Urocell. Urocell is a body*s own product existing of autologous myoblasts and
fibroblasts and collagen. The purpose of the
Sponsors
Innovacell Biotechnologie GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age 18-70 years * Verified diagnosis of urinary incontinence * Stress- or mixed urinary incontinence (without severe descensus of pelvic organs or dominant urgency complaints)
Exclusion criteria
Exclusion criteria: * A neurological disorder as the sole reason for the incontinence * Women with marked descensus of the pelvic organs or marked hypermobility of the urethra *Pregnancy * Allergy against collagen * (Planned) treatment with immunosuppressive medication or any immunosupression therapy * Previous X-ray treatment of pelvic organs * Severe autoimmune disease * Bladder instability and/or pure urge incontinence * Lactating patients * Previous treatment with TVT, TOT or bulking agents * Malignancy treated or apt to be treated by x-ray therapy or chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of the urinary incontinence score. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Urodynamics: function of the urinary vesicle and the urethral closure pressure pre- and post-therapy. - Sonography and elastography of the urethra: the urethra, contractility of the rhabdosphincter, thickness and morphology of the rhabdosphincter before and after therapy. - Contilife questionnaire | — |
Countries
Netherlands
Outcome results
None listed