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

Phase 2

Withdrawn

• Conditions: involuntary urine loss; stress incontinence; 10046447; 10024450; 10038365

• Registration Number: NL-OMON30498
• Lead Sponsor: Innovacell Biotechnologie GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 25

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

* 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified