Royan Institute
Tehran, Iran
NCT Number: NCT02156934
This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.
Looking for future studies?
Notify Me40 year–60 year
Female
Interventional
Phase 2
Tehran, Iran
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
Time frame: 1 month
Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.
Time frame: 1month
Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form.
Royan Institute
Other Gov
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
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.