NCT03882632

Brief Summary

Fecal Incontinence affects an estimated 2-20% of the general population, and up to 50% of the elderly and institutionalized population. Patients with incontinence tend to suffer in silence; they often do not seek help because of embarrassment and stigma. They often become confined to their homes because they are afraid of having an "accident". Although this is not a life-threatening condition, the psychological, emotional, and social impact can be devastating.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

April 11, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

March 18, 2019

Last Update Submit

July 7, 2020

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (2)

  • Resolution of Fecal Incontinence Measured by patient reported outcomes on questionnaires

    Comparison of pre and post procedure outcomes via outcomes questionaires

    2 years

  • Resolution of Fecal Incontinence Measured by Physical Exam

    Comparison of pre and post procedure outcomes via Endoanal Ultrasound and Physiology Testing

    2 years

Secondary Outcomes (1)

  • Incident of treatment related adverse events

    2 years

Study Arms (1)

Patients with Fecal Incontinence

EXPERIMENTAL

Patients will have the opportunity to undergo adipose tissue harvesting and targeted local Injection under ultrasound guidance in muscle defects in the intersphincteric space, all around the remaining portions of the external anal sphincter, and along the course of the pudendal nerves bilaterally

Device: Fat Grafting for Fecal Incontinence

Interventions

Fat Grafting for Fecal IncontinenceDEVICE

Autologous adiopse tissue harvesting/grafting using Lipogems

Also known as: Fat Grafting
Patients with Fecal Incontinence

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale Patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: \>18 \< 65 years
  • Sex: females
  • Affected by fecal incontinence (moderate to severe) independently from the etiology and previous treatments
  • No restrictions to follow-up for 24 months after treatment
  • Willing and able to provide informed consent

You may not qualify if:

  • Present diagnosis of cancer (not in remission)
  • Patients with uncorrected rectal prolapse
  • Overflow incontinence
  • Patients with neurogenic bowel or spinal cord injuries
  • Any patients unable to give informed consent, including members of vulnerable populations
  • Patients with concomitant pelvic floor disorders, like paradoxical puborectalis contraction or pelvic floor dysfunction
  • Chronic diarrhea
  • Patients with chronic steroid use
  • Patients 17 and under
  • Anal Sepsis (abscess and/or fistula)
  • Inability to undergo the intended diagnostic tests and follow-up
  • Pregnancy
  • Diagnosis of Diabetes Mellitus 1 and 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lifespan

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Melanie Salerno

CONTACT

4014447148melanie.salerno@brownphysicians.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Leslie Roth

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 20, 2019

Study Start

April 11, 2019

Primary Completion

April 1, 2021

Study Completion

December 1, 2021

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

US(1)