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,
fibroblasts and collagen in medium.
Sponsors
Innovacell Biotechnologie GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Verified diagnosis of urinary incontinence by medical history and urodynamics * Stress urinary incontinence (without severe prolapse of pelvic organs or dominant urgency complaints) * Lack of improvement of continence after 12 treatments of pelvic floor exercises * Age from 18 up to and including 75 years * Life expectancy of 10 years or more
Exclusion criteria
Exclusion criteria: * Any neurological disorder * Bladder instability during urodynamics and pure urge incontinence * Men with a sealing defect in the anastomosis (bypass gap in the urethra) following radical prostatectomy as visualised during cystoscopy * Women with marked prolapse of the pelvic organs or marked hypermobility of the urethra (Q-tip test > 30%) * Previous treatment with TVT, TOT or bulking agents * Pregnancy: women in childbearing age can be treated with Urocell, if no pregnancy is diagnosed at admission and if effective contraceptive measures are undertaken pre- and post-operatively (during entire study period) * Lactating women * Patient is treated with immunosuppressive medication or any immunosuppressive therapy is intended * Diagnosis of a malignant disease which is treated or about to be treated with radiotherapy or chemotherapy * Patients who have had radiotherapy of pelvic organs * Severe autoimmune disease * Collagen allergy * Patient is HIV, Hepatitis B or Hepatitis C positive * Patients who cannot follow instructions regarding the protocol or cannot fill in the micturition diary, 24 hour pad test, or quality of life questionnaire (CONTILIFE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Serious) Adverse Events, abnormalities found in the physical examination, occurrence of infection parameters in the blood samples or urine sediment, abnormalities found in (video) urodynamic investigations, abnormalities found in endo-MRI, cystoscopy, TUUS, TRUS/TVUS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life (CONTILIFE) or in the Urine Incontinence Score from baseline to endpoint, change in urodynamic investigations and urethral pressure profile before and after injection with Urocell. | — |
Countries
Netherlands
Outcome results
None listed