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

Not Applicable

• Conditions: Urinary Incontinence,Stress
• Interventions: Procedure: Autologous adipose tissue harvesting/grafting using Lipogems

• Registration Number: NCT03295253
• Lead Sponsor: The Miriam Hospital

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.

Study Timeline

• Study Start: 2016-12-15
• Study First Submitted: 2017-08-02
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-22
• Last Update Submitted: 2017-09-22
• Study First Posted: 2017-09-27
• Last Update Posted: 2017-09-27
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Female patients with Stress Incontinence	Autologous adipose tissue harvesting/grafting using Lipogems	Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck

Primary Outcome Measures

Name	Time	Method
Resolution of Stress urinary Incontinence Measured by patient reported pad count	2 years	Comparison of pre and post procedure patient pad count
Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies	2 years	Comparison of pre and post procedure patient Urodynamic studies
Resolution of Stress urinary Incontinence Measured by patient cough stress test	2 years	Comparison of pre and post procedure patient cough stress test
Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire	2 years	Comparison of pre and post procedure patient reported outcomes questionnaire

Trial Locations

Locations (1)

The Miriam Hospital/ Women Medicine Collaborative; 🇺🇸 Providence, Rhode Island, United States