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:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01647906
First received: June 27, 2012
Last updated: January 31, 2013
Last verified: January 2013
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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 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 4 months after the last primary Solesta treatment.
- Occurrence of device related 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 [ Time Frame: Assessed at baseline, 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, 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 [ Time Frame: Assessed at baseline, 6, 12, and 36 months after last Solesta treatment ] [ Designated as safety issue: No ]The effectiveness endpoint of Cleveland Clinic Florida Fecal Incontinence Score 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 ultrasound. Relative anatomic stability of Solesta will be assessed by comparing anatomical positioning of the Solesta implant, as determined by ultrasound, at the time of injection to positioning at 6 and 36 months after the last Solesta treatment to 1) confirm the presence or absence of Solesta implants and 2) determine if any local shift has occurred.
- Occurence 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: | June 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 potential must be using a form of medically acceptable contraception and have a negative urine pregnancy test at Screening and immediately prior to receiving a second injection with Solesta. 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 pregnant or lactating.
- 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) in anorectal region.
- 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 PAS Protocol.
--Has had a sphincteroplasty within 12 months of enrollment.
- Has any bleeding disorder.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647906
Locations
| United States, California | |
| Salix Investigational Site | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Salix Investigational Site | |
| Ft. Lauderdale, Florida, United States, 33331 | |
| Salix Investigational Site | |
| Tampa, Florida, United States, 33606 | |
| Salix Investigational Site | |
| Weston, Florida, United States, 33331 | |
| United States, Iowa | |
| Salix Investigational Site | |
| Des Moines, Iowa, United States, 50266 | |
| United States, Minnesota | |
| Salix Investigational Site | |
| Minneapolis, Minnesota, United States, 55407 | |
| United States, New York | |
| Salix Investigational Site | |
| New York, New York, United States, 10029 | |
| Salix Investigational Site | |
| New York, New York, United States, 10016 | |
| United States, Oklahoma | |
| Salix Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Salix Investigational Site | |
| Allentown, Pennsylvania, United States, 18103 | |
| United States, Vermont | |
| Salix Investigational Site | |
| 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: | January 31, 2013 |
| 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 June 18, 2013