Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
SoFI
A Prospective, Single Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
1 other identifier
observational
277
1 country
20
Brief Summary
The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2012
CompletedFirst Submitted
Initial submission to the registry
June 27, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2018
CompletedNovember 25, 2019
November 1, 2019
6.3 years
June 27, 2012
November 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom from fecal incontinence reintervention
The primary effectiveness endpoint is freedom from Fecal Incontinence Reintervention. Patients will be evaluated at 3, 6, 12, 24, and 36 months after the last Solesta treatment for the occurrence (or lack of occurrence) of Fecal Incontinence Reintervention. Fecal Incontinence Reintervention includes Fecal Incontinence treatment of sphincteroplasty, implantation of artificial bowel sphincter, retreatment with Solesta, graciloplasty, sacral nerve stimulation (SNS) or other surgical interventions that occur more than 3 months after the last primary Solesta treatment.
Through 36 months after the last Solesta treatment
Secondary Outcomes (6)
Fecal Incontinence Quality of Life (FIQL)
Assessed at baseline, 3, 6, 12, and 36 months after last Solesta treatment.
Cleveland Clinic Florida Fecal Incontinence Score (CCFIS)
Assessed at baseline,3, 6, 12, and 36 months after last Solesta treatment
Global Perceived Effect Score
Assessed at 6, 12 and 36 months after last Solesta treatment
Time to Fecal Incontinence Reintervention
Assessed from 6 to 36 months after last Solesta treatment
Anatomic stability of the Solesta
Assessed at time of Solesta treatment and again at 6 and 36 months after the last Solesta treatment.
- +1 more secondary outcomes
Eligibility Criteria
Patients with Fecal Incontinence.
You may qualify if:
- Able to fluently speak and understand the language in which the study is being conducted and able to provide meaningful written informed consent for the study.
- Have FI, have failed conservative therapy (e.g., diet, fiber therapy, medications that treat diarrhea), and are scheduled to receive Solesta treatment.
- Females must be of non-childbearing potential; or females of childbearing (reproductive) potential must agree to use an acceptable method of contraception for at least the first 6 months of study participation and have a negative urine pregnancy test at Visit 1 (Screening/Baseline) and immediately prior to receiving initial Solesta treatment. Women who are surgically sterile or those who are post menopausal for at least 2 years prior to entering the study are not considered to be of childbearing potential.
- Willing to return to the study facility for the post treatment evaluation.
You may not qualify if:
- Is currently pregnant, breastfeeding, or is planning to become pregnant over the course of the study.
- Has an active inflammatory bowel disease.
- Has an immunodeficiency disorder or ongoing immunosuppressive therapy.
- Has received previous radiation treatment to the pelvic area.
- Has significant mucosal or full thickness rectal prolapse.
- Has active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or other infections.
- Has anorectal atresia, tumors, stenosis or malformation.
- Has a rectocele.
- Has rectal varices.
- Has presence of existing implant including Solesta, artificial bowel sphincter, or sacral nerve stimulator (activated or inactivated).
- Has an allergy to hyaluronic acid (HA) based products.
- Has an anastomosis to the rectum or anus within 10 cm of the dentate line.
- Has an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the requirements of the post-approval study protocol.
- Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
- Has undergone sphincteroplasty, graciloplasty, or other surgical interventions (without the use of an implanted device) for treatment of fecal incontinence within 12 months of enrollment.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Colon and Rectal Medical Services
Los Angeles, California, 90048, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
Galliano Private Practice
Port Charlotte, Florida, 33948, United States
USF Health
Tampa, Florida, 33606, United States
North Pinellas Surgical Institute
Tarpon Springs, Florida, 34689, United States
Cleveland Clinic Florida Health
Weston, Florida, 33331, United States
Emory University
Atlanta, Georgia, 30322, United States
Georgia Regents Research Institute
Augusta, Georgia, 30912, United States
The Iowa Clinic
Des Moines, Iowa, 50266, United States
Colon and Rectal Surgery Associates, Ltd.
Minneapolis, Minnesota, 55407, United States
Colon and Rectal Surgery, LLC
Omaha, Nebraska, 68114, United States
North Shore Long Island Jewish Health Systems
Huntington, New York, 11743, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Cleveland Clinic Foundation Digestive Disease Institute
Cleveland, Ohio, 44195, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Colon and Rectal Research Foundation
Allentown, Pennsylvania, 18103, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
University of Vermont Medical Center
Burlington, Vermont, 05446, United States
Related Publications (1)
Quiroz LH, Galliano DE Jr, da Silva G, Carmichael JC, Pan LC, Bromley ER, Hinahara JG, Goss TF. Efficacy and Safety of a Nonanimal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence: A Prospective, Single-Arm, Multicenter, Clinical Study With 36-Month Follow-up. Dis Colon Rectum. 2023 Feb 1;66(2):278-287. doi: 10.1097/DCR.0000000000002348. Epub 2023 Jan 4.
PMID: 35001051DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2012
First Posted
July 24, 2012
Study Start
May 31, 2012
Primary Completion
September 15, 2018
Study Completion
September 15, 2018
Last Updated
November 25, 2019
Record last verified: 2019-11