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Completed

NCT Number: NCT01963455

Autologous Muscle Derived Stem Cells Transplantation in Urine Incontinency

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

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Key information

Conditions

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paraurethral injection of MDCs

Biological

MDCs transplantation by paraurethral injection .

Other names: MDCs transplantion by paraurethral injection.

Primary outcomes

  1. 24hours voiding diary reduction

    Time frame: 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 outcomes

  1. Enhance incontinence quality of life (I-Qol)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 16, 2013
Registry last updated
May 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.