Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE June 2, 2014
First Posted Date  ICMJE June 5, 2014
Last Update Posted Date December 4, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
24hr voiding diary reduction [ Time Frame: 1 month ]
Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02156934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2014)
incontinence quality of life (I-Qol) [ Time Frame: 1month ]
Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress Urine Incontinency
Intervention  ICMJE Biological: paraurethral injection
Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
Study Arms  ICMJE Experimental: Muscle derived stem cell
Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
Intervention: Biological: paraurethral injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02156934
Other Study ID Numbers  ICMJE Royan-Kidney-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Royan Institute
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP