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

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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Incontinence,Stress
• Intervention / Treatment: Procedure: Autologous adipose tissue harvesting/grafting using Lipogems

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02904
      • Recruiting
      • The Miriam Hospital/ Women Medicine Collaborative
      • Contact: Patrizia Curran, MD; Phone Number: 401-793-7824; Email: pcurran1@lifespan.org
      • Contact: Janice Santos, MD; Phone Number: 1321 401-421-0710; Email: janice.santos-cortes@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Female patients with Stress Incontinence; Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck	Procedure: Autologous adipose tissue harvesting/grafting using Lipogems; Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment related adverse events	site-reported adverse events designated as related to the treatment	2 years

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Investigators: Principal Investigator: Janice Santos, MD, Women Medicine Collaborative/The Miriam Hospital; Study Director: Patrizia Curran, MD, The Miriam Hospital/ Women Medicine Collaborative

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): December 15, 2018

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 27, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: stress urinary incontinence; urinary incontinence; stress incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 212516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No