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

September 22, 2017 updated by: Janice Santos Cortes, The Miriam Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 years
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
2 years
Resolution of Stress urinary Incontinence Measured by patient reported pad count
Time Frame: 2 years
Comparison of pre and post procedure patient pad count
2 years
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
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment related adverse events
Time Frame: 2 years
site-reported adverse events designated as related to the treatment
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Miriam Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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