An interventional study of Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) in Fecal Incontinence, sponsored by Galderma R&D. Completed at 15 sites in 7 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment
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.
312 studies on the registry are indexed under Fecal Incontinence; 57 are open to participants now.
This study's enrollment of 115 is above the median of 50 across 216 interventional studies indexed under Fecal Incontinence.
Browse Fecal Incontinence studies →Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open label. Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) The study treatment consisted of 4 submucosal injections, 1 mL Solesta each, in the proximal part of the high pressure zone in the anal canal. Re-treatment is allowed one month after initial treatment if the subject is still incontinent.
Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)
Also known as: Solesta
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
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
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
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
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
| Milestone | Solesta |
|---|---|
| Started | 115 |
| Completed | 83 |
| Not completed | 32 |
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.
| percentage of responders | Solesta |
|---|---|
| Responder Rate in Number of Fecal Incontinence Episodes | 64.4 (54.3 to 74.4) |
Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).
| episodes | Solesta |
|---|---|
| Number of Fecal Incontinence Episodes. | -10.94 (-82.2 to 45.6) |
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.
| units on a scale | Solesta |
|---|---|
| Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score | -4.79 (-18.0 to 5.0) |
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.
| score on a scale | Solesta |
|---|---|
| Lifestyle | 0.49 (-1.3 to 2.9) |
| Coping/behaviour | 0.66 (-1.2 to 3.0) |
| Depression/Self perception | 0.52 (-2.5 to 3.0) |
| Embarrassment | 0.78 (-1.7 to 3.0) |
Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).
| days | Solesta |
|---|---|
| Number of Incontinence-free Days | 7.1 (-21.5 to 28) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Solesta | — | 19/115 (16.5%) | 20/115 (17.4%) |
| Event | Solesta |
|---|---|
| Rectal prolapseGastrointestinal disorders | 2/115 |
| ProctalgiaGastrointestinal disorders | 2/115 |
| Perineal abscessInfections and infestations | 1/115 |
| Rectovaginal septum abscessInfections and infestations | 1/115 |
| Rectal abscessInfections and infestations | 1/115 |
| Rectal hemorrhageGastrointestinal disorders | 1/115 |
| Abdominal painGastrointestinal disorders | 1/115 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/115 |
| Breast infectionInfections and infestations | 1/115 |
| Cardiac failure acuteCardiac disorders | 1/115 |
| Event | Solesta |
|---|---|
| ProctalgiaGastrointestinal disorders | 15/115 |
| PyrexiaGeneral disorders | 8/115 |
| Age, Continuous(years) | Solesta |
|---|---|
| Mean | 62.5 ± 11.9 |
| Sex: Female, Male(Participants) | Solesta |
|---|---|
| Female | 100 |
| Male | 15 |
| Region of Enrollment(participants) | Solesta |
|---|---|
| France | 23 |
| Canada | 12 |
| Finland | 10 |
| Spain | 16 |
| Norway | 3 |
| Germany | 21 |
| Italy | 30 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Galderma R&D