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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01647906
First received: June 27, 2012
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

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.


Condition
Fecal Incontinence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Freedom from fecal incontinence reintervention [ Time Frame: Through 36 months after the last Solesta treatment ] [ Designated as safety issue: No ]
    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.

  • Occurrence of device related adverse events (AEs) [ Time Frame: Through 36 months after the last Solesta treatment ] [ Designated as safety issue: Yes ]
    The primary safety endpoint will be the occurrence of device related AEs. Patients will be evaluated at 3, 6, 12, 24, and 36 months after the last Solesta treatment. All AEs will be collected and causal relationship to the device will be assessed by the investigator.


Secondary Outcome Measures:
  • Fecal Incontinence Quality of Life (FIQL) [ Time Frame: Assessed at baseline, 3, 6, 12, and 36 months after last Solesta treatment. ] [ Designated as safety issue: No ]
    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.

  • Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) [ Time Frame: Assessed at baseline,3, 6, 12, and 36 months after last Solesta treatment ] [ Designated as safety issue: No ]
    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).

  • Global Perceived Effect Score [ Time Frame: Assessed at 6, 12 and 36 months after last Solesta treatment ] [ Designated as safety issue: No ]
    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.

  • Time to Fecal Incontinence Reintervention [ Time Frame: Assessed from 6 to 36 months after last Solesta treatment ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • Occurrence of any peri-injection device related infectious adverse events. [ Time Frame: Assessed from time of injection up to 2 weeks after Solesta treatment ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 244
Study Start Date: May 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Fecal Incontinence.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647906

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

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01647906     History of Changes
Other Study ID Numbers: CL SLP001
Study First Received: June 27, 2012
Last Updated: September 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014