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Fecal IncontinenceSoFINCT01647906

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

An observational study of Fecal Incontinence, run by Bausch Health Americas, Inc. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fecal Incontinence
How many people
277 participants
Where
20 sitesUnited States
Study dates
31 May 2012to 15 Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Fecal Incontinence.

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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Colon and Rectal Research Foundation

    Allentown, Pennsylvania, 18103

  • Emory University

    Atlanta, Georgia, 30322

  • Georgia Regents Research Institute

    Augusta, Georgia, 30912

  • University of Vermont Medical Center

    Burlington, Vermont, 05446

  • Cleveland Clinic Foundation Digestive Disease Institute

    Cleveland, Ohio, 44195

  • The Iowa Clinic

    Des Moines, Iowa, 50266

  • North Shore Long Island Jewish Health Systems

    Huntington, New York, 11743

  • Colon and Rectal Medical Services

    Los Angeles, California, 90048

  • Colon and Rectal Surgery Associates, Ltd.

    Minneapolis, Minnesota, 55407

  • NYU Langone Medical Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Colon and Rectal Surgery, LLC

    Omaha, Nebraska, 68114

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Galliano Private Practice

    Port Charlotte, Florida, 33948

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • USF Health

    Tampa, Florida, 33606

  • North Pinellas Surgical Institute

    Tarpon Springs, Florida, 34689

  • Cleveland Clinic Florida Health

    Weston, Florida, 33331

Other trials in United States

About this study

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)

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.

Read the 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.

Medical subject headings
Fecal Incontinence

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Through 36 months after the last Solesta treatment

Secondary outcomes (6)

  1. Fecal Incontinence Quality of Life (FIQL)

    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.

    Measured: Assessed at baseline, 3, 6, 12, and 36 months after last Solesta treatment.

  2. Cleveland Clinic Florida Fecal Incontinence Score (CCFIS)

    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).

    Measured: Assessed at baseline,3, 6, 12, and 36 months after last Solesta treatment

  3. Global Perceived Effect Score

    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.

    Measured: Assessed at 6, 12 and 36 months after last Solesta treatment

  4. Time to Fecal Incontinence Reintervention

    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.

    Measured: Assessed from 6 to 36 months after last Solesta treatment

  5. Anatomic stability of the Solesta

    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.

    Measured: Assessed at time of Solesta treatment and again at 6 and 36 months after the last Solesta treatment.

  6. Occurrence of any peri-injection device related infectious adverse events.

    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.

    Measured: Assessed from time of injection up to 2 weeks after Solesta treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2012 (estimated)
  2. Study start31 May 2012
  3. Primary completion15 Sep 2018
  4. Study completion15 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
277 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01647906
Sponsor's protocol ID
CL SLP001
Acronym
SoFI
Status last verified
Nov 2019
First submitted
27 Jun 2012
Last updated
25 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 35001051

Questions about this trial

What is this clinical trial studying?

An observational study of Fecal Incontinence, run by Bausch Health Americas, Inc. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from fecal incontinence reintervention (time frame: Through 36 months after the last Solesta treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01647906, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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