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. Identifier: NCT01110681
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):
Q-Med AB

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) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
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 : November 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Open label.
Device: 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.
Other Name: Solesta

Primary Outcome Measures :
  1. Number of fecal incontinence episodes [ Time Frame: 12 months after last treatment ]

Secondary Outcome Measures :
  1. Number of fecal incontinence episodes and incontinence-free days [ Time Frame: up to 24 months after last treatment ]
  2. Fecal incontinence severity using the Cleveland Clinic Florida Incontinence Score [ Time Frame: up to 24 months after last treatment ]
    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.

  3. Fecal Incontinence Quality of Life [ Time Frame: up to 24 months after last treatment ]
    Fecal Incontinence Quality of Life is a disease specific questionnaire with questions divided into four domains: Lifestyle, Coping/Behavior, Depression/Self perception, and Embarrassment.

  4. Number of subjects with Adverse Events as a measure of safety and tolerability [ Time Frame: Up to 24 months after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 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
Koloproktologische Praxis
Kiel, Germany, 24105
Klinik für Allgemein- und Vizeralchirurgie
Ludwigsburg, Germany, 71640
Enddarmzentrum Mannheim
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
Akershus universitetssykehus
Nordbyhagen, Norway, 1474
Hospital Clinic Provincial
Barcelona, Spain, 08036
Hospital Juan Ramón Jiménez
Huelva, Spain, 21005
Hospital General Univ. de Valéncia
Valéncia, Spain, 46014
Sponsors and Collaborators
Q-Med AB
Study Director: Head of Medical Affairs Q-Med AB Q-Med AB
Principal Investigator: Tom Oresland, MD Akershus University Hospital, Lorenskog, Norway

Responsible Party: Q-Med AB Identifier: NCT01110681     History of Changes
Other Study ID Numbers: 33DA0605, Q-Med AB
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases