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

Phase 2

Completed

• Conditions: Stress Urine Incontinency
• Interventions: Biological: paraurethral injection

• Registration Number: NCT02156934
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Status Verified: 2013-10
• Study Start: 2014-01
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscle derived stem cell	paraurethral injection	Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.

Primary Outcome Measures

Name	Time	Method
24hr voiding diary reduction	1 month	Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.

Secondary Outcome Measures

Name	Time	Method
incontinence quality of life (I-Qol)	1month	Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of