Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03295253
Status:
UNKNOWN
Last Update Posted:
2017-09-27
First Post:
2017-08-02
Brief Title:
Fat Grafting Technique Using Autologous Adipose Tissue Lipogems in Patients Suffering From Stress Urinary Incontinence
Sponsor:
The Miriam Hospital
Organization:
The Miriam Hospital
Study Overview
Official Title:
Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 theyve 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
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 theyve 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None