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

NCT03295253 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-09-27

No results posted yet for this study

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.

Conditions

  • Urinary Incontinence,Stress

Interventions

PROCEDURE

Autologous adipose tissue harvesting/grafting using Lipogems

Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems

Sponsors & Collaborators

  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Janice Santos, MD · Women Medicine Collaborative/The Miriam Hospital

  • Patrizia Curran, MD · The Miriam Hospital/ Women Medicine Collaborative

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2018-12-15
Completion
2018-12-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03295253 on ClinicalTrials.gov