Study to Evaluate Solesta for Treatment of Fecal Incontinence

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01110681
• Collaborator: (none)
• Enrollment: 115
• Locations: 15
• Arm: 1
• Duration (Months): 37
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence	Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 115 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Nov 1, 2009
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Solesta 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); Other Names: Solesta

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

2. 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.

3. 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.

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Paul's Hospital	Vancouver		Canada	V6Z1Y6
2	Helsingin yliopistollinen keskussairaala	HUS		Finland	00029
3	CHU-Hotel-Dieu	Nantes		France	44093
4	Hôpital Saint Joseph	Paris		France	75674
5	CHU de Rouen 1 rue Germont service de chirurgie et digestive	Rouen		France	76031
6	Koloproktologische Praxis	Kiel		Germany	24105
7	Klinik für Allgemein- und Vizeralchirurgie	Ludwigsburg		Germany	71640
8	Enddarmzentrum Mannheim	Mannheim		Germany	68165
9	University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza	Bari		Italy	70124
10	Univ. degli Studi di Padova Hospital Clinica Chirurgica	Padova		Italy	35128
11	Policlinico Umberto I	Rome		Italy	00161
12	Akershus universitetssykehus	Nordbyhagen		Norway	1474
13	Hospital Clinic Provincial	Barcelona		Spain	08036
14	Hospital Juan Ramón Jiménez	Huelva		Spain	21005
15	Hospital General Univ. de Valéncia	Valéncia		Spain	46014

Sponsors and Collaborators

• Galderma R&D

Investigators

• Study Director: Head of Medical Affairs Q-Med AB, Galderma R&D
• Principal Investigator: Tom Oresland, MD, Akershus University Hospital, Lorenskog, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01110681
• Other Study ID Numbers: 33DA0605, Q-Med AB
• First Posted: Apr 27, 2010
• Last Update Posted: Feb 28, 2019
• Last Verified: Dec 1, 2013

• Additional relevant MeSH terms: Fecal Incontinence

Study Results

Participant Flow

Arm/Group Title	Solesta
Arm/Group Description	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.
Period Title: Overall Study
STARTED	115
COMPLETED	83
NOT COMPLETED	32

Baseline Characteristics

Arm/Group Title	Solesta
Arm/Group Description	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 Participants	115
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (11.9)
Sex: Female, Male (Count of Participants)
Female	100 87%
Male	15 13%
Region of Enrollment (participants) [Number]
France	23 20%
Canada	12 10.4%
Finland	10 8.7%
Spain	16 13.9%
Norway	3 2.6%
Germany	21 18.3%
Italy	30 26.1%

Outcome Measures

1. Primary Outcome

Title	Responder Rate in Number of Fecal Incontinence Episodes
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Solesta
Arm/Group Description	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.
Measure Participants	87
Number (95% Confidence Interval) [percentage of responders]	64.4

2. Secondary Outcome

Title	Number of Fecal Incontinence Episodes.
Description	Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).
Time Frame	at 12 month - change from baseline

Outcome Measure Data

Analysis Population Description

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/Group Title	Solesta
Arm/Group Description	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.
Measure Participants	88
Mean (Full Range) [episodes]	-10.94

3. Secondary Outcome

Title	Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Solesta
Arm/Group Description	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.
Measure Participants	90
Mean (Full Range) [units on a scale]	-4.79

4. Secondary Outcome

Title	Fecal Incontinence Quality of Life (FIQL)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Solesta
Arm/Group Description	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.
Measure Participants	77
Lifestyle	0.49
Coping/behaviour	0.66
Depression/Self perception	0.52
Embarrassment	0.78

5. Secondary Outcome

Title	Number of Incontinence-free Days
Description	Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).
Time Frame	At 12 month- change from baseline

Outcome Measure Data

Analysis Population Description

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/Group Title	Solesta
Arm/Group Description	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.
Measure Participants	88
Mean (Full Range) [days]	7.1

Adverse Events

Arm/Group Title	Solesta
Arm/Group Description	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.
All Cause Mortality
	Solesta
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Solesta
	Affected / at Risk (%)	# Events
Total	19/115 (16.5%)
Cardiac disorders
Cardiac failure acute	1/115 (0.9%)	2
Endocrine disorders
Hypothyriodism	1/115 (0.9%)	1
Gastrointestinal disorders
Rectal prolapse	2/115 (1.7%)	2
Rectal hemorrhage	1/115 (0.9%)	3
Proctalgia	2/115 (1.7%)	2
Abdominal pain	1/115 (0.9%)	1
Constipation	1/115 (0.9%)	1
Diarrhoea	1/115 (0.9%)	1
Fecal incontinence	1/115 (0.9%)	1
Gastroenteritis	1/115 (0.9%)	1
Hemorrhoidal haemorrhage	1/115 (0.9%)	1
Hepatobiliary disorders
Cholecystitis	1/115 (0.9%)	1
Cholecystitis acute	1/115 (0.9%)	1
Polycystic liver disease	1/115 (0.9%)	1
Immune system disorders
Sjögrens syndrome	1/115 (0.9%)	1
Infections and infestations
Perineal abscess	1/115 (0.9%)	1
Rectovaginal septum abscess	1/115 (0.9%)	1
Rectal abscess	1/115 (0.9%)	1
Breast infection	1/115 (0.9%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	1/115 (0.9%)	1
Rotator cuff syndrome	1/115 (0.9%)	1
Reproductive system and breast disorders
Postmenopausal hemorrhage	1/115 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Solesta
	Affected / at Risk (%)	# Events
Total	20/115 (17.4%)
Gastrointestinal disorders
Proctalgia	15/115 (13%)	15
General disorders
Pyrexia	8/115 (7%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.