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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02156934

Enrollment

Registered

2014-06-05

Start date

2014-01-31

Completion date

2015-12-31

Last updated

2015-12-04

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

Conditions

Stress Urine Incontinency

Keywords

autologous stress urinary incontinence muscle derived cells

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.

Interventions

BIOLOGICALparaurethral injection

Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 60 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
24hr voiding diary reduction	1 month	Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.

Secondary

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

Countries

Iran

Outcome results

None listed

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