N/A
N=206
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00605826 ↗Enrolled (actual)
206
Serious AEs
15.0%
Results posted
Aug 2020
Primary outcome: Primary: Percentage of Participants Who Are Responder50. — 71; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NASHA/Dx (Solesta) Gel (Device); Sham Injection (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Are Responder50. |
71; 21 | — |
| PRIMARY Percentage of Participants Who Are Responder25. |
69.1 | — |
| SECONDARY Number of Fecal Incontinence Episodes |
16.28; 18.53 | — |
| SECONDARY Number of Incontinence Free Days |
7.6; 6.48 | — |
| SECONDARY Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). |
0.29; 0.42; 0.30; 0.45 | — |
| SECONDARY Cleveland Clinic Florida Incontinence Score (CCFIS). |
-2.45 | — |
Summary
The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.
Eligibility Criteria
Inclusion Criteria
- 18-75 years of age, male or female.
- Screening fecal incontinence severity score (CCFIS).
- Fecal incontinence episodes over a 14-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 (IBD).
- Immunodeficiency or receiving immunosuppressive therapy.
- Malignancies in remission for less than 2 years prior to the study.
- Bleeding disorders or receiving anticoagulant therapy.
- Chemotherapy within the last 12 months prior to the study.
- Prior Pelvic radiotherapy.
- Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
- Women within one year post partum.
- Participation in any other clinical study within 3 month prior to the study.
- Hypersensitivity to hyaluronic acid containing products.
- Other severe conditions or in other ways unsuitable to participate according to investigator judgement.
Data sourced from ClinicalTrials.gov (NCT00605826). 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.