Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI) (SoFI)

November 21, 2019 updated by: Bausch Health Americas, Inc.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
277

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Los Angeles, California, United States, 90048
        • Colon and Rectal Medical Services
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center
    • Florida
      • Port Charlotte, Florida, United States, 33948
        • Galliano Private Practice
      • Tampa, Florida, United States, 33606
        • USF Health
      • Tarpon Springs, Florida, United States, 34689
        • North Pinellas Surgical Institute
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida Health
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Augusta, Georgia, United States, 30912
        • Georgia Regents Research Institute
    • Iowa
      • Des Moines, Iowa, United States, 50266
        • The Iowa Clinic
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Colon and Rectal Surgery Associates, Ltd.
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Colon and Rectal Surgery, LLC
    • New York
      • Huntington, New York, United States, 11743
        • North Shore Long Island Jewish Health Systems
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation Digestive Disease Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Colon and Rectal Research Foundation
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
    • Vermont
      • Burlington, Vermont, United States, 05446
        • University of Vermont Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Fecal Incontinence.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from fecal incontinence reintervention
Time Frame: Through 36 months after the last Solesta treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fecal Incontinence Quality of Life (FIQL)
Time Frame: Assessed at baseline, 3, 6, 12, and 36 months after last Solesta treatment.
The effectiveness endpoint of Fecal Incontinence Quality of Life using the Rockwood instrument will be assessed at baseline, 3, 6, 12, and 36 months after last Solesta treatment. Patients will fill out a questionnaire at screening visit and at follow up visits. The Fecal Incontinence Quality of Life instrument is a questionnaire completed by patients that assesses the impact of quality of life as it relates to Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The FIQL instrument consists of a total of 29 questions.
Assessed at baseline, 3, 6, 12, and 36 months after last Solesta treatment.
Cleveland Clinic Florida Fecal Incontinence Score (CCFIS)
Time Frame: Assessed at baseline,3, 6, 12, and 36 months after last Solesta treatment
The effectiveness endpoint of CCFIS will be assessed at baseline, 6, 12, and 36 months after last Solesta treatment. The investigator will calculate the CCFIS based on a patient interview. The CCFIS is a summed score of 5 individual parameters (i.e., frequency of incontinence to gas, liquid, solid, of need to wear pad, and of lifestyle changes).
Assessed at baseline,3, 6, 12, and 36 months after last Solesta treatment
Global Perceived Effect Score
Time Frame: Assessed at 6, 12 and 36 months after last Solesta treatment
The effectiveness endpoint of Global Perceived Effect Score will be assessed at 6, 12 and 36 months after last Solesta treatment. Global perceived effect is a subjective score and reflects the patient perception of their degree of FI after treatment compared to the period before treatment and ranges from 1-7 points.
Assessed at 6, 12 and 36 months after last Solesta treatment
Time to Fecal Incontinence Reintervention
Time Frame: Assessed from 6 to 36 months after last Solesta treatment
For patients who undergo Fecal Incontinence Reintervention the effectiveness endpoint of Time to Fecal Incontinence Reintervention will be measured from the date of last treatment with Solesta to the date of first Fecal Incontinence Reintervention. Fecal incontinence reinterventions will include any of the following FI treatments: sphincteroplasty, implantation of artificial bowel sphincter, retreatment with Solesta, graciloplasty, SNS or other surgical interventions.
Assessed from 6 to 36 months after last Solesta treatment
Anatomic stability of the Solesta
Time Frame: Assessed at time of Solesta treatment and again at 6 and 36 months after the last Solesta treatment.
Assess the relative anatomic stability of the Solesta Injectable Bulking Agent in a subpopulation of patients enrolled at 3-4 sites as assessed by transrectal ultrasound. Solesta will be assessed by comparing anatomical positioning of the Solesta implant, as determined by transrectal ultrasound at Visit 3a (for patients who did not receive a second Solesta treatment) or Visit 3b (for patients who received a second Solesta treatment at Visit 3a) to positioning at 6 and 36 months after the last Solesta treatment.
Assessed at time of Solesta treatment and again at 6 and 36 months after the last Solesta treatment.
Occurrence of any peri-injection device related infectious adverse events.
Time Frame: Assessed from time of injection up to 2 weeks after Solesta treatment
A secondary safety endpoint will be the occurrence of peri-injection device related infectious Adverse Events for patients treated with or without prophylactic antibiotics (as decided by treating physician) prior to injection.
Assessed from time of injection up to 2 weeks after Solesta treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL SLP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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