- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156934
Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency
December 3, 2015 updated by: Royan Institute
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
This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tehran, Iran, Islamic Republic of
- Royan Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Muscle derived stem cell
Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
|
Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24hr voiding diary reduction
Time Frame: 1 month
|
Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incontinence quality of life (I-Qol)
Time Frame: 1month
|
Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form.
|
1month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
June 2, 2014
First Submitted That Met QC Criteria
June 3, 2014
First Posted (Estimate)
June 5, 2014
Study Record Updates
Last Update Posted (Estimate)
December 4, 2015
Last Update Submitted That Met QC Criteria
December 3, 2015
Last Verified
October 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Royan-Kidney-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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