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Autologous Adipose Tissue Grafting

Female patients with Stress Incontinence for Stress Incontinence

N/A
Waitlist Available
Led By Janice Santos, MD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

Eligible Conditions
  • Stress Incontinence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Resolution of Stress urinary Incontinence Measured by patient cough stress test
Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies
Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire
+1 more
Other outcome measures
Incidence of treatment related adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Female patients with Stress IncontinenceExperimental Treatment1 Intervention
Female patients who will undergo autologous adipose tissue harvesting/grafting using Lipogems and grafting in urethra/bladder neck

Find a Location

Who is running the clinical trial?

The Miriam HospitalLead Sponsor
238 Previous Clinical Trials
37,450 Total Patients Enrolled
Janice Santos, MDPrincipal InvestigatorWomen Medicine Collaborative/The Miriam Hospital
Patrizia Curran, MDStudy DirectorThe Miriam Hospital/ Women Medicine Collaborative

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Apr 2025