Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency

Study Overview
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Brief Summary
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This study was designed to provide confirmation of safety of muscle derived cell (MDCs) for the treatment of stress urine incontinency (SUI) in women.

Detailed Description
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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.

Official Title
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The Effect Evaluation of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Urinary Incontinency

Conditions
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Stress Incontinency

Intervention / Treatment
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* Biological: paraurethral injection of MDCs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Stress Urinary Incontinence symptoms Urodynamic stress incontinence confirmed with multichannel urodynamic testing positive cough stress test urgency score < stress score Patient's age between 40 - 65 years Desire to surgical correction of stress urinary incontinence or inadequate response to conservative treatment of SUI Exclusion Criteria: Post-void residual volume >100cc Detrusor overactivity on preoperative multichannel urodynamic testing History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra Desires future childbearing Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurative History of bleeding diathesis or current anti-coagulation therapy Inguinal lymphadenopathy or inguinal/vulvar mass Current genitourinary fistula or urethral diverticulum Current sever cystocele or rectocele Active urinary infection Non-treated urge incontinency or any significant voiding dysfunction Neuromuscular disorders Uncontrolled Diabetes Reversible cause of incontinence (i.e. drug effect) Contraindications for surgery

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MDCs transplant<br>The women who have stress urinary incontinency. | Biological: paraurethral injection of MDCs<br>* MDCs transplantation by paraurethral injection .<br>* Other names: MDCs transplantion by paraurethral injection.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplantation autologous stress urinary incontinence, muscle derived cells