Fat Grafting Technique Using Autologous Adipose Tissue Lipogems in Patients Suffering From Stress Urinary Incontinence

Urinary Incontinence,Stress Clinical Trial

Official title:

Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295253
• Other study ID #: 212516
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2017
• Last updated: September 22, 2017
• Start date: December 15, 2016
• Est. completion date: December 15, 2018

Study information

• Verified date: September 2017
• Source: The Miriam Hospital
• Contact: Janice Santos, MD
• Phone: 401-421-0710
• Email: janice.santos-cortes[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

Procedure:
• Autologous adipose tissue harvesting/grafting using Lipogems
Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems

Locations

Country	Name	City	State
United States	The Miriam Hospital/ Women Medicine Collaborative	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of treatment related adverse events	site-reported adverse events designated as related to the treatment	2 years
Primary	Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire	Comparison of pre and post procedure patient reported outcomes questionnaire	2 years
Primary	Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies	Comparison of pre and post procedure patient Urodynamic studies	2 years
Primary	Resolution of Stress urinary Incontinence Measured by patient reported pad count	Comparison of pre and post procedure patient pad count	2 years
Primary	Resolution of Stress urinary Incontinence Measured by patient cough stress test	Comparison of pre and post procedure patient cough stress test	2 years