An interventional study of Autologous adipose tissue harvesting/grafting using Lipogems in Urinary Incontinence,Stress, sponsored by The Miriam Hospital. Status unknown at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-27.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment
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.
Female patients with:
Exclusion Criteria:
Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck
Procedure: Autologous adipose tissue harvesting/grafting using Lipogems
Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems
Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire
Comparison of pre and post procedure patient reported outcomes questionnaire
Time frame: 2 years
Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies
Comparison of pre and post procedure patient Urodynamic studies
Time frame: 2 years
Resolution of Stress urinary Incontinence Measured by patient reported pad count
Comparison of pre and post procedure patient pad count
Time frame: 2 years
Resolution of Stress urinary Incontinence Measured by patient cough stress test
Comparison of pre and post procedure patient cough stress test
Time frame: 2 years
Incidence of treatment related adverse events
site-reported adverse events designated as related to the treatment
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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The Miriam Hospital