Clinical trial NCT03295253: Fat Grafting Technique Using Autologous Adipose Tissue Lipogems in Patients Suffering From Stress Urinary Incontinence
Official title: Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence,Stress
Keywords: urinary incontinence
stress urinary incontinence
stress incontinence
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: Inclusion Criteria:

Female patients with:

1. stress incontinence (SUI)
2. mixed urinary incontinence (SUI main component)
3. Intrinsic Sphincter Deficiency (ISD)

Exclusion Criteria:

1. Present diagnosis of cancer (not in remission)
2. Patients with uncorrected vaginal prolapse (cystocele or utero/bladder prolapse)
3. Incontinence of unknown etiology (other medical reasons) overflow incontinence
4. Patients with neurogenic bladder
5. Any patients unable to give informed consent, including members of vulnerable populations
6. Patients with concomitant pelvic floor disorders, like interstitial cystitis or pelvic floor dysfunction
7. Vulvar dermatosis, herpes simplex or active or recurrent urinary tract infection
8. Patients with chronic steroid use
9. Patients 17 and under

Primary outcomes:
measure: Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire
timeFrame: 2 years
measure: Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies
timeFrame: 2 years
measure: Resolution of Stress urinary Incontinence Measured by patient reported pad count
timeFrame: 2 years
measure: Resolution of Stress urinary Incontinence Measured by patient cough stress test
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: Incidence of treatment related adverse events
timeFrame: 2 years
Locations:
city: Providence
country: United States
facility: The Miriam Hospital/ Women Medicine Collaborative
state: Rhode Island
Study officials:
affiliation: Women Medicine Collaborative/The Miriam Hospital
name: Janice Santos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital/ Women Medicine Collaborative
name: Patrizia Curran, MD
role: STUDY_DIRECTOR
References: