Urinary Incontinence,Stress Clinical Trial
Official title:
Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or
menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the
vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral
sphincter all result in stress incontinence, urge incontinence and sometimes mixed
incontinence respectively.
The purpose of this study is to evaluate reconstructive lipoplasty with micro-fragmented
autologous adipose tissue (Lipogems®) in female patients with stress urinary incontinence.
This is a prospective study of 25 subjects that will be evaluated over a period of one year.
The treatment consist of the injection of micro fragmented adipose tissue, previously
extracted from the patient in the area of the urethral sphyncter.
Patients will have follow ups at 6 months with Urodynamic studies to measure the pre-post
injection differences to-date. Visual analog score questionnaire and report in subjective
improvement, pad use and stress cough test will be documented at 1, 3, 6, and 12 months
follow-up.
Urinary incontinence affects more than 200 million people worldwide. In women, childbirth or
menopausal aging atrophic vagina, lack of estrogen stimulation of muscular turgor of the
vagina, decrease tone of the urogenital diaphragm, attenuation and weakening of the urethral
sphincter all result in stress incontinence, urge incontinence and sometimes mixed
incontinence respectively. The purpose of this study is to evaluate reconstructive lipoplasty
with micro-fragmented autologous adipose tissue (Lipogems®) in female patients with stress
urinary incontinence. This is a prospective study of 25 subjects that will be evaluated over
a period of one year.
Different available treatments for stress urinary incontinence (SUI) are surgical: MMK, R A
Z, Burch, (TOT, T VT-mesh sling) and urethral bulking agents. New treatments using
mesenchymal stem cells have been tested for the last eight years and now moved from animal
models to humans with positive results.
Subjects will receive a full history and examination by a single urologist. A clear history
of their incontinence pattern, the amount of incontinence based on PAD counts, under what
conditions incontinence occurs to categorize type of incontinence for the female patient pre-
or post-menopause. Childbirth history, age of onset, time of occurrence, predisposing
factors, medications, hormones, etc. all patients will be registered and categorized
according to incontinence.
The patients will receive reconstructive lipoplasty with micro-fragmented autologous adipose
tissue (Lipogems®).
Subjects will log their results immediately post injection and then daily for up to two years
noting any changes they've noticed in their presenting problems. At 6 months Urodynamic
studies will be performed to measure the pre-post injection differences to-date. Visual
analog score questionnaire and report in subjective improvement, pad use and stress cough
test will be documented at 1, 3, 6, and 12 months follow-up.
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