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

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ClinicalTrials.gov Identifier: NCT03295253
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Janice Santos Cortes, 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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence,Stress Procedure: Autologous adipose tissue harvesting/grafting using Lipogems Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Fat Grafting Technique Using Autologous Micro-fragmented Autologous Adipose Tissue Lipogems in Female Patients Suffering From Stress Urinary Incontinence
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire [ Time Frame: 2 years ]
    Comparison of pre and post procedure patient reported outcomes questionnaire

  2. Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies [ Time Frame: 2 years ]
    Comparison of pre and post procedure patient Urodynamic studies

  3. Resolution of Stress urinary Incontinence Measured by patient reported pad count [ Time Frame: 2 years ]
    Comparison of pre and post procedure patient pad count

  4. Resolution of Stress urinary Incontinence Measured by patient cough stress test [ Time Frame: 2 years ]
    Comparison of pre and post procedure patient cough stress test


Other Outcome Measures:
  1. Incidence of treatment related adverse events [ Time Frame: 2 years ]
    site-reported adverse events designated as related to the treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295253


Contacts
Contact: Janice Santos, MD 401-421-0710 ext 1321 janice.santos-cortes@lifespan.org
Contact: Patrizia Curran, MD 401-793-7824 pcurran1@lifespan.org

Locations
United States, Rhode Island
The Miriam Hospital/ Women Medicine Collaborative Recruiting
Providence, Rhode Island, United States, 02904
Contact: Janice Santos, MD    401-421-0710 ext 1321    janice.santos-cortes@lifespan.org   
Contact: Patrizia Curran, MD    401-793-7824    pcurran1@lifespan.org   
Sponsors and Collaborators
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

Responsible Party: Janice Santos Cortes, Assistant Professor of Surgery (Urology), The Miriam Hospital
ClinicalTrials.gov Identifier: NCT03295253     History of Changes
Other Study ID Numbers: 212516
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Janice Santos Cortes, The Miriam Hospital:
urinary incontinence
stress urinary incontinence
stress incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders