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

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ClinicalTrials.gov Identifier: NCT02156934
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stress Urine Incontinency Biological: paraurethral injection Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Muscle derived stem cell
Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
Biological: paraurethral injection
Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.




Primary Outcome Measures :
  1. 24hr voiding diary reduction [ Time Frame: 1 month ]
    Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.


Secondary Outcome Measures :
  1. incontinence quality of life (I-Qol) [ Time Frame: 1month ]
    Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02156934


Locations
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Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
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Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute
Study Director: Farzaneh Sharifiaghdas, MD Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Principal Investigator: Farshad Zohrabi, MD Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences
Principal Investigator: Reza Moghadasali, PhD Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology

Additional Information:
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Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT02156934     History of Changes
Other Study ID Numbers: Royan-Kidney-002
First Posted: June 5, 2014    Key Record Dates
Last Update Posted: December 4, 2015
Last Verified: October 2013
Keywords provided by Royan Institute:
autologous stress urinary incontinence muscle derived cells