This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for the treatment of stress urine incontinency (SUI) in women.
The investigators will be assessed the 12-month safety and potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 10 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 30×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
MDCs transplantation by paraurethral injection .
Royan Institute
Tehran, Iran
24hours voiding diary reduction
Evaluation the 24hours voiding diary reduction by patient questionaire 2h pad test and By clinical measures by cystourethroscopy and urodynamic before , 1, 3,6 and 12 months after MDCs injection.
Time frame: 1month
Enhance incontinence quality of life (I-Qol)
Evaluation the enhance incontinence quality of life (I-Qol) by questionnaire form, before injection of MDCs, 1, 3,6 and 12 months after injection.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.