Clinical trial NCT01647906: Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Fecal Incontinence.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria: A patient will be eligible for study participation if he/she meets the following criteria:

* 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.

Exclusion Criteria: A patient will be excluded from the study if he/she meets any of the following criteria:

* 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.
* Has any bleeding disorder.

Primary outcomes:
measure: Freedom from fecal incontinence reintervention
timeFrame: Through 36 months after the last Solesta treatment
Secondary outcomes:
measure: Fecal Incontinence Quality of Life (FIQL)
timeFrame: Assessed at baseline, 3, 6, 12, and 36 months after last Solesta treatment.
measure: Cleveland Clinic Florida Fecal Incontinence Score (CCFIS)
timeFrame: Assessed at baseline,3, 6, 12, and 36 months after last Solesta treatment
measure: Global Perceived Effect Score
timeFrame: Assessed at 6, 12 and 36 months after last Solesta treatment
measure: Time to Fecal Incontinence Reintervention
timeFrame: Assessed from 6 to 36 months after last Solesta treatment
measure: Anatomic stability of the Solesta
timeFrame: Assessed at time of Solesta treatment and again at 6 and 36 months after the last Solesta treatment.
measure: Occurrence of any peri-injection device related infectious adverse events.
timeFrame: Assessed from time of injection up to 2 weeks after Solesta treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Los Angeles
country: United States
facility: Colon and Rectal Medical Services
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Port Charlotte
country: United States
facility: Galliano Private Practice
state: Florida
city: Tampa
country: United States
facility: USF Health
state: Florida
city: Tarpon Springs
country: United States
facility: North Pinellas Surgical Institute
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida Health
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Georgia Regents Research Institute
state: Georgia
city: Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Minneapolis
country: United States
facility: Colon and Rectal Surgery Associates, Ltd.
state: Minnesota
city: Omaha
country: United States
facility: Colon and Rectal Surgery, LLC
state: Nebraska
city: Huntington
country: United States
facility: North Shore Long Island Jewish Health Systems
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Digestive Disease Institute
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Allentown
country: United States
facility: Colon and Rectal Research Foundation
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
References:
citation: 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.