Trial Outcomes & Findings for Study to Evaluate Solesta for Treatment of Fecal Incontinence (NCT NCT01110681)
NCT ID: NCT01110681
Last Updated: 2022-08-26
Results Overview
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.
COMPLETED
NA
115 participants
12 months after last treatment compared to baseline
2022-08-26
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Solesta for Treatment of Fecal Incontinence
Baseline characteristics by cohort
| Measure |
Solesta
n=115 Participants
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.
|
|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 11.9 • n=39 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
|
Region of Enrollment
France
|
23 participants
n=39 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=39 Participants
|
|
Region of Enrollment
Finland
|
10 participants
n=39 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=39 Participants
|
|
Region of Enrollment
Norway
|
3 participants
n=39 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=39 Participants
|
|
Region of Enrollment
Italy
|
30 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 12 months after last treatment compared to baselinePopulation: 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.
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.
Outcome measures
| Measure |
Solesta
n=87 Participants
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.
|
|---|---|
|
Responder Rate in Number of Fecal Incontinence Episodes
|
64.4 percentage of responders
Interval 54.3 to 74.4
|
SECONDARY outcome
Timeframe: at 12 month - change from baselinePopulation: 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.
Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).
Outcome measures
| Measure |
Solesta
n=88 Participants
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.
|
|---|---|
|
Number of Fecal Incontinence Episodes.
|
-10.94 episodes
Interval -82.2 to 45.6
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SECONDARY outcome
Timeframe: 12 month - change from baselinePopulation: 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.
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.
Outcome measures
| Measure |
Solesta
n=90 Participants
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.
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|---|---|
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Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score
|
-4.79 units on a scale
Interval -18.0 to 5.0
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SECONDARY outcome
Timeframe: At 12 month - change from baselinePopulation: 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.
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.
Outcome measures
| Measure |
Solesta
n=77 Participants
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.
|
|---|---|
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Fecal Incontinence Quality of Life (FIQL)
Lifestyle
|
0.49 score on a scale
Interval -1.3 to 2.9
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Fecal Incontinence Quality of Life (FIQL)
Coping/behaviour
|
0.66 score on a scale
Interval -1.2 to 3.0
|
|
Fecal Incontinence Quality of Life (FIQL)
Depression/Self perception
|
0.52 score on a scale
Interval -2.5 to 3.0
|
|
Fecal Incontinence Quality of Life (FIQL)
Embarrassment
|
0.78 score on a scale
Interval -1.7 to 3.0
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SECONDARY outcome
Timeframe: At 12 month- change from baselinePopulation: 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.
Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).
Outcome measures
| Measure |
Solesta
n=88 Participants
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.
|
|---|---|
|
Number of Incontinence-free Days
|
7.1 days
Interval -21.5 to 28.0
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Adverse Events
Solesta
Serious adverse events
| Measure |
Solesta
n=115 participants at risk
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.
|
|---|---|
|
Infections and infestations
Perineal abscess
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0.87%
1/115 • Number of events 1
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Infections and infestations
Rectovaginal septum abscess
|
0.87%
1/115 • Number of events 1
|
|
Infections and infestations
Rectal abscess
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Rectal prolapse
|
1.7%
2/115 • Number of events 2
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.87%
1/115 • Number of events 3
|
|
Gastrointestinal disorders
Proctalgia
|
1.7%
2/115 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.87%
1/115 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.87%
1/115 • Number of events 1
|
|
Infections and infestations
Breast infection
|
0.87%
1/115 • Number of events 1
|
|
Cardiac disorders
Cardiac failure acute
|
0.87%
1/115 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis
|
0.87%
1/115 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.87%
1/115 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoidal haemorrhage
|
0.87%
1/115 • Number of events 1
|
|
Endocrine disorders
Hypothyriodism
|
0.87%
1/115 • Number of events 1
|
|
Hepatobiliary disorders
Polycystic liver disease
|
0.87%
1/115 • Number of events 1
|
|
Reproductive system and breast disorders
Postmenopausal hemorrhage
|
0.87%
1/115 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.87%
1/115 • Number of events 1
|
|
Immune system disorders
Sjögrens syndrome
|
0.87%
1/115 • Number of events 1
|
Other adverse events
| Measure |
Solesta
n=115 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Proctalgia
|
13.0%
15/115 • Number of events 15
|
|
General disorders
Pyrexia
|
7.0%
8/115 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60