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

NCT03295253 | Unknown DMC

• 1 other identifier: 212516
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence,Stress

Keywords

urinary incontinence; stress urinary incontinence; stress incontinence

Outcome Measures

Primary Outcomes (4)

• Resolution of Stress urinary Incontinence Measured by patient reported outcomes on questionnaire

  Comparison of pre and post procedure patient reported outcomes questionnaire

  2 years

• Resolution of Stress urinary Incontinence Measured by patient outcomes on Urodynamic Studies

  Comparison of pre and post procedure patient Urodynamic studies

  2 years

• Resolution of Stress urinary Incontinence Measured by patient reported pad count

  Comparison of pre and post procedure patient pad count

  2 years

• Resolution of Stress urinary Incontinence Measured by patient cough stress test

  Comparison of pre and post procedure patient cough stress test

  2 years

Other Outcomes (1)

• Incidence of treatment related adverse events

  2 years

Study Arms (1)

Female patients with Stress Incontinence

EXPERIMENTAL

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

Interventions

Autologous adipose tissue harvesting/grafting using Lipogems PROCEDURE

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

Female patients with Stress Incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with:
• stress incontinence (SUI)
• mixed urinary incontinence (SUI main component)
• Intrinsic Sphincter Deficiency (ISD)

You may not qualify if:

• Present diagnosis of cancer (not in remission)
• Patients with uncorrected vaginal prolapse (cystocele or utero/bladder prolapse)
• Incontinence of unknown etiology (other medical reasons) overflow incontinence
• Patients with neurogenic bladder
• Any patients unable to give informed consent, including members of vulnerable populations
• Patients with concomitant pelvic floor disorders, like interstitial cystitis or pelvic floor dysfunction
• Vulvar dermatosis, herpes simplex or active or recurrent urinary tract infection
• Patients with chronic steroid use
• Patients 17 and under

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital/ Women Medicine Collaborative

Providence, Rhode Island, 02904, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janice Santos, MD

  Women Medicine Collaborative/The Miriam Hospital

  PRINCIPAL INVESTIGATOR

• Patrizia Curran, MD

  The Miriam Hospital/ Women Medicine Collaborative

  STUDY DIRECTOR

Central Study Contacts

Janice Santos, MD

CONTACT

401-421-0710; janice.santos-cortes@lifespan.org

Patrizia Curran, MD

CONTACT

401-793-7824; pcurran1@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery (Urology)

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: September 27, 2017
• Study Start: December 15, 2016
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: September 27, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)