Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency

Study Overview
=================
Brief Summary
-----------------
This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.

Detailed Description
-----------------
The investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 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
-----------------
Evaluation the Effect of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Stress Urinary Incontinency,The Randomized Clinical Trial Phase II

Conditions
-----------------
Stress Urine Incontinency

Intervention / Treatment
-----------------
* Biological: paraurethral injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle derived stem cell<br>Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency. | Biological: paraurethral injection<br>* Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24hr voiding diary reduction | Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incontinence quality of life (I-Qol) | Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form. | 1month | 

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