Fat Grafting Technique Using Autologous Adipose Tissue Lipogems in Patients Suffering From Stress Urinary Incontinence
Status unconfirmed · Not applicable
Conditions studied: Urinary Incontinence,Stress
In brief
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.
Key facts
- Study ID
- NCT03295253
- Run by
- The Miriam Hospital
- People needed
- 25
- Starts
- 2016-12-15
- Expected to finish
- 2018-12-15
- Last updated by the study team
- 2017-09-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female patients with:
- stress incontinence (SUI)
- mixed urinary incontinence (SUI main component)
- Intrinsic Sphincter Deficiency (ISD)
You may not qualify if…
- 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
Where it is running
- The Miriam Hospital/ Women Medicine Collaborative — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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