Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01963455

Enrollment

Registered

2013-10-16

Start date

2013-01-31

Completion date

2014-09-30

Last updated

2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Incontinency

Keywords

transplantation autologous stress urinary incontinence, muscle derived cells

Brief summary

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

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.

Interventions

BIOLOGICALparaurethral injection of MDCs

MDCs transplantation by paraurethral injection .

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
24hours voiding diary reduction	1month	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.

Secondary

Measure	Time frame	Description
Enhance incontinence quality of life (I-Qol)	1 month	Evaluation the enhance incontinence quality of life (I-Qol) by questionnaire form, before injection of MDCs, 1, 3,6 and 12 months after injection.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026