Study to Evaluate Solesta for Treatment of Fecal Incontinence
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01110681|
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||November 2007|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2010|
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 Name: Solesta
- Responder Rate in Number of Fecal Incontinence Episodes [ Time Frame: 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.
- Number of Fecal Incontinence Episodes. [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.
- Number of Incontinence-free Days [ Time Frame: At 12 month- change from baseline ]Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110681
|St. Paul's Hospital|
|Vancouver, Canada, V6Z1Y6|
|Helsingin yliopistollinen keskussairaala|
|HUS, Finland, 00029|
|Nantes, France, 44093|
|Hôpital Saint Joseph|
|Paris, France, 75674|
|CHU de Rouen 1 rue Germont service de chirurgie et digestive|
|Rouen, France, 76031|
|Kiel, Germany, 24105|
|Klinik für Allgemein- und Vizeralchirurgie|
|Ludwigsburg, Germany, 71640|
|Mannheim, Germany, 68165|
|University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza|
|Bari, Italy, 70124|
|Univ. degli Studi di Padova Hospital Clinica Chirurgica|
|Padova, Italy, 35128|
|Policlinico Umberto I|
|Rome, Italy, 00161|
|Nordbyhagen, Norway, 1474|
|Hospital Clinic Provincial|
|Barcelona, Spain, 08036|
|Hospital Juan Ramón Jiménez|
|Huelva, Spain, 21005|
|Hospital General Univ. de Valéncia|
|Valéncia, Spain, 46014|
|Study Director:||Head of Medical Affairs Q-Med AB||Q-Med AB|
|Principal Investigator:||Tom Oresland, MD||Akershus University Hospital, Lorenskog, Norway|