Safety of transurethral ultrasound directed injection of autologous myoblasts, fibroblasts and collagen in patients with urinary stress incontinence - Safety of Urocell in stress incontinence

Innovacell Biotechnologie GmbH0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年5月13日

试验速览

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•* 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

•* 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)

发起方

Innovacell Biotechnologie GmbH