N/A
N=115
Study to Evaluate Solesta for Treatment of Fecal Incontinence
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01110681 ↗Enrolled (actual)
115
Serious AEs
16.5%
Results posted
Feb 2019
Primary outcome: Primary: Responder Rate in Number of Fecal Incontinence Episodes — 64.4 percentage of responders
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate in Number of Fecal Incontinence Episodes |
64.4 | — |
| SECONDARY Number of Fecal Incontinence Episodes. |
-10.94 | — |
| SECONDARY Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score |
-4.79 | — |
| SECONDARY Fecal Incontinence Quality of Life (FIQL) |
0.49; 0.66; 0.52; 0.78 | — |
| SECONDARY Number of Incontinence-free Days |
7.1 | — |
Summary
The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed treatment.
Eligibility Criteria
Inclusion Criteria
- 18-80 years of age, male or female
- Screening fecal incontinence severity score (CCFIS)
- Fecal incontinence episodes over a 28-day period
- Failed conservative treatment for fecal incontinence
Exclusion Criteria
- Complete external sphincter disruption
- Significant anorectal disease
- Anorectal surgery within the last 12 months prior to the study
- Active Inflammatory Bowel Disease
- Immunodeficiency or receiving immunosuppressive therapy
- Malignancies in remission for less than 1 years prior to the study
- Bleeding disorders or receiving anticoagulant therapy
- Chemotherapy within the last 6 months prior to the study
- Prior Pelvic radiotherapy
- Pregnant or breast-feeding women, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study
- Women within 6 months post partum
- Participation in any other clinical study within 3 month prior to the study
- Other severe conditions or in other ways unsuitable to participate according to investigator judgement
Data sourced from ClinicalTrials.gov (NCT01110681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.