Fecal Incontinence
Conditions
Brief 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.
Detailed description
Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx. Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study.
Interventions
DEVICENASHA/Dx (Solesta) Gel
Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
DEVICESham Injection
Sham injection at the start of the blinded phase.
Sponsors
Oceana Therapeutics, Inc.
Galderma R&D
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Are Responder50. | 6 months after last blinded treatment | Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50). |
| Percentage of Participants Who Are Responder25. | 12 months after last treatment | Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Fecal Incontinence Episodes | up to 6 months after last treatment | The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits. |
| Number of Incontinence Free Days | up to 6 months after last treatment | The number of days with no fecal incontinence episodes (incontinence free days). |
| Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). | up to 6 months after last treatment | The disease-specific Fecal Incontinence Quality of Life (FIQL) questionnaire is designed to capture the impact of treatment on quality of life for participants suffering from fecal incontinence as it pertains to 4 domains: Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The more the subject is affected by fecal incontinence the lower the value. Hence, a positive change from baseline indicates improvement. Scores range from 1 to 4. |
| Cleveland Clinic Florida Incontinence Score (CCFIS). | up to 6 months after last treatment | Cleveland Clinic Florida Incontinence Score (CCFIS) score was based on a participant interview using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage and lifestyle alterations during the past month. The score ranged from 0 (perfect) to 20 (complete incontinence) |
Countries
Germany, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NashaDx/Fecal NashaDx/Fecal - 4 syringes each containing 1 mL of product | 136 |
| Sham Sham - 4 empty syringes | 70 |
| Total | 206 |
Baseline characteristics
| Characteristic | NashaDx/Fecal | Sham | Total |
|---|---|---|---|
| Age, Continuous | 60.6 years | 59.2 years | 60.1 years |
| Sex: Female, Male Female | 122 Participants | 61 Participants | 183 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 78 / 206 |
| serious Total, serious adverse events | 31 / 206 |
Outcome results
Primary
Percentage of Participants Who Are Responder25.
Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25).
Time frame: 12 months after last treatment
Population: This outcome measure was only analyzed for the NASHA/Dx group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NashaDx/Fecal | Percentage of Participants Who Are Responder25. | 69.1 percentage of participants |
Primary
Percentage of Participants Who Are Responder50.
Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).
Time frame: 6 months after last blinded treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NashaDx/Fecal | Percentage of Participants Who Are Responder50. | 71 Participants |
| Sham | Percentage of Participants Who Are Responder50. | 21 Participants |
Secondary
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).
The disease-specific Fecal Incontinence Quality of Life (FIQL) questionnaire is designed to capture the impact of treatment on quality of life for participants suffering from fecal incontinence as it pertains to 4 domains: Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The more the subject is affected by fecal incontinence the lower the value. Hence, a positive change from baseline indicates improvement. Scores range from 1 to 4.
Time frame: up to 6 months after last treatment
Population: This outcome measure was only analyzed for the NASHA/Dx group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NashaDx/Fecal | Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). | Lifestyle domain | 0.29 units on a scale | Standard Error 0.05 |
| NashaDx/Fecal | Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). | Coping/Behavior domain | 0.42 units on a scale | Standard Error 0.05 |
| NashaDx/Fecal | Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). | Depression/Self perception domain | 0.30 units on a scale | Standard Error 0.05 |
| NashaDx/Fecal | Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL). | Embarrassment domain | 0.45 units on a scale | Standard Error 0.06 |
Secondary
Cleveland Clinic Florida Incontinence Score (CCFIS).
Cleveland Clinic Florida Incontinence Score (CCFIS) score was based on a participant interview using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage and lifestyle alterations during the past month. The score ranged from 0 (perfect) to 20 (complete incontinence)
Time frame: up to 6 months after last treatment
Population: This outcome measure was only analyzed for the NASHA/Dx group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NashaDx/Fecal | Cleveland Clinic Florida Incontinence Score (CCFIS). | -2.45 units on a scale | Standard Error 0.31 |
Secondary
Number of Fecal Incontinence Episodes
The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits.
Time frame: up to 6 months after last treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NashaDx/Fecal | Number of Fecal Incontinence Episodes | 16.28 number of episodes | Standard Error 2.15 |
| Sham | Number of Fecal Incontinence Episodes | 18.53 number of episodes | Standard Error 5.56 |
Secondary
Number of Incontinence Free Days
The number of days with no fecal incontinence episodes (incontinence free days).
Time frame: up to 6 months after last treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NashaDx/Fecal | Number of Incontinence Free Days | 7.6 incontinence free days |
| Sham | Number of Incontinence Free Days | 6.48 incontinence free days |