Fecal Incontinence
Conditions
Brief 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.
Interventions
DEVICESolesta (Dextranomer in gel of stabilized non-animal hyaluronate)
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate in Number of Fecal Incontinence Episodes | 12 months after last treatment compared to baseline | Responder rate in number of fecal incontinence episodes change from baseline at 12 month. Defined as responders at 12 month after treatment. A responder was defined as 50% or more reduction in the number of fecal incontinence episodes (28-day diary data)of solid or loose stool, compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Incontinence-free Days | At 12 month- change from baseline | Number of incontinence-free days, change from baseline (change in patient diary data at 12 month). |
| Number of Fecal Incontinence Episodes. | at 12 month - change from baseline | Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month). |
| Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score | 12 month - change from baseline | Cleveland Clinic Florida Incontinence Score (CCFIS) is a composite score of incontinence severity that measures the frequencies of gas leakage, leakage of solid or loose stool, use of protective pads and lifestyle alterations. The score ranges from 0 (representing complete continence)to 20 (representing complete incontinence). Change from baseline. |
| Fecal Incontinence Quality of Life (FIQL) | At 12 month - change from baseline | Fecal Incontinence Quality of Life is a disease specific questionnaire composed of a total of 29 questions questions divided into four domains: Lifestyle, Coping/Behavior, Depression/Self perception, and Embarrassment. The FIQL mean score ranges from 1 to 4 for the Lifestyle, Coping/Behavior and Embarrassment domains, and from 1 to 4.429 for Depression/Self-Perception domain. Mean score were calculated for each of the four domains. The more the subject is affected by fecal incontinence the lower value. Change from baseline. |
Countries
Canada, Finland, France, Germany, Italy, Norway, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solesta Open label.
Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) : Submucosal injections. Re-treatment is allowed one month after initial treatment if the subject is still incontinent. | 115 |
| Total | 115 |
Baseline characteristics
| Characteristic | Solesta |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 11.9 |
| Region of Enrollment Canada | 12 participants |
| Region of Enrollment Finland | 10 participants |
| Region of Enrollment France | 23 participants |
| Region of Enrollment Germany | 21 participants |
| Region of Enrollment Italy | 30 participants |
| Region of Enrollment Norway | 3 participants |
| Region of Enrollment Spain | 16 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 115 |
| serious Total, serious adverse events | 19 / 115 |
Outcome results
Primary
Responder Rate in Number of Fecal Incontinence Episodes
Responder rate in number of fecal incontinence episodes change from baseline at 12 month. Defined as responders at 12 month after treatment. A responder was defined as 50% or more reduction in the number of fecal incontinence episodes (28-day diary data)of solid or loose stool, compared to baseline.
Time frame: 12 months after last treatment compared to baseline
Population: Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solesta | Responder Rate in Number of Fecal Incontinence Episodes | 64.4 percentage of responders |
Secondary
Fecal Incontinence Quality of Life (FIQL)
Fecal Incontinence Quality of Life is a disease specific questionnaire composed of a total of 29 questions questions divided into four domains: Lifestyle, Coping/Behavior, Depression/Self perception, and Embarrassment. The FIQL mean score ranges from 1 to 4 for the Lifestyle, Coping/Behavior and Embarrassment domains, and from 1 to 4.429 for Depression/Self-Perception domain. Mean score were calculated for each of the four domains. The more the subject is affected by fecal incontinence the lower value. Change from baseline.
Time frame: At 12 month - change from baseline
Population: Intention to treat. Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Solesta | Fecal Incontinence Quality of Life (FIQL) | Lifestyle | 0.49 score on a scale |
| Solesta | Fecal Incontinence Quality of Life (FIQL) | Coping/behaviour | 0.66 score on a scale |
| Solesta | Fecal Incontinence Quality of Life (FIQL) | Depression/Self perception | 0.52 score on a scale |
| Solesta | Fecal Incontinence Quality of Life (FIQL) | Embarrassment | 0.78 score on a scale |
Secondary
Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score
Cleveland Clinic Florida Incontinence Score (CCFIS) is a composite score of incontinence severity that measures the frequencies of gas leakage, leakage of solid or loose stool, use of protective pads and lifestyle alterations. The score ranges from 0 (representing complete continence)to 20 (representing complete incontinence). Change from baseline.
Time frame: 12 month - change from baseline
Population: Intention to treat. Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Solesta | Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score | -4.79 units on a scale |
Secondary
Number of Fecal Incontinence Episodes.
Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).
Time frame: at 12 month - change from baseline
Population: Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Solesta | Number of Fecal Incontinence Episodes. | -10.94 episodes |
Secondary
Number of Incontinence-free Days
Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).
Time frame: At 12 month- change from baseline
Population: Intention to treat (all subjects who were treated with study product). Primary analysis were based on observed data. A Last-Observation-Carried -Forward (LOCF) technique was also used where the last performed efficacy assessment was carried forward to impute any subsequent missing values.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Solesta | Number of Incontinence-free Days | 7.1 days |