Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Resolution of Stress urinary Incontinence Measured by patient reported pad count
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients with:
- •stress incontinence (SUI)
- •mixed urinary incontinence (SUI main component)
- •Intrinsic Sphincter Deficiency (ISD)
排除标准
- •Present diagnosis of cancer (not in remission)
- •Patients with uncorrected vaginal prolapse (cystocele or utero/bladder prolapse)
- •Incontinence of unknown etiology (other medical reasons) overflow incontinence
- •Patients with neurogenic bladder
- •Any patients unable to give informed consent, including members of vulnerable populations
- •Patients with concomitant pelvic floor disorders, like interstitial cystitis or pelvic floor dysfunction
- •Vulvar dermatosis, herpes simplex or active or recurrent urinary tract infection
- •Patients with chronic steroid use
- •Patients 17 and under
研究组 & 干预措施
Female patients with Stress Incontinence
Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck
干预措施: Autologous adipose tissue harvesting/grafting using Lipogems (Procedure)
结局指标
主要结局
Resolution of Stress urinary Incontinence Measured by patient reported pad count
时间窗: 2 years
Comparison of pre and post procedure patient pad count
Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies
时间窗: 2 years
Comparison of pre and post procedure patient Urodynamic studies
Resolution of Stress urinary Incontinence Measured by patient cough stress test
时间窗: 2 years
Comparison of pre and post procedure patient cough stress test
Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire
时间窗: 2 years
Comparison of pre and post procedure patient reported outcomes questionnaire
次要结局
未报告次要终点
研究者
Janice Santos Cortes
Assistant Professor of Surgery (Urology)
The Miriam Hospital