Fat Grafting Technique Using Autologous Adipose Tissue Lipogems in Patients Suffering From Stress Urinary Incontinence
NCT ID: NCT03295253
Last Updated: 2017-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
25 participants
INTERVENTIONAL
2016-12-15
2018-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Female patients with Stress Incontinence
Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck
Autologous adipose tissue harvesting/grafting using Lipogems
Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autologous adipose tissue harvesting/grafting using Lipogems
Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. stress incontinence (SUI)
2. mixed urinary incontinence (SUI main component)
3. Intrinsic Sphincter Deficiency (ISD)
Exclusion Criteria
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
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Miriam Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Janice Santos Cortes
Assistant Professor of Surgery (Urology)
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janice Santos, MD
Role: PRINCIPAL_INVESTIGATOR
Women Medicine Collaborative/The Miriam Hospital
Patrizia Curran, MD
Role: STUDY_DIRECTOR
The Miriam Hospital/ Women Medicine Collaborative
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Miriam Hospital/ Women Medicine Collaborative
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
212516
Identifier Type: -
Identifier Source: org_study_id