Study to Evaluate Solesta for Treatment of Fecal Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01110681
First received: April 9, 2010
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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 Intervention
Fecal Incontinence
Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Q-Med AB:

Primary Outcome Measures:
  • Number of fecal incontinence episodes [ Time Frame: 12 months after last treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of fecal incontinence episodes and incontinence-free days [ Time Frame: up to 24 months after last treatment ] [ Designated as safety issue: No ]
  • Fecal incontinence severity using the Cleveland Clinic Florida Incontinence Score [ Time Frame: up to 24 months after last treatment ] [ Designated as safety issue: No ]
    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.

  • Fecal Incontinence Quality of Life [ Time Frame: up to 24 months after last treatment ] [ Designated as safety issue: No ]
    Fecal Incontinence Quality of Life is a disease specific questionnaire with questions divided into four domains: Lifestyle, Coping/Behavior, Depression/Self perception, and Embarrassment.

  • Number of subjects with Adverse Events as a measure of safety and tolerability [ Time Frame: Up to 24 months after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: November 2007
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Solesta
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110681

Locations
Canada
St. Paul's Hospital
Vancouver, Canada, V6Z1Y6
Finland
Helsingin yliopistollinen keskussairaala
HUS, Finland, 00029
France
CHU-Hotel-Dieu
Nantes, France, 44093
Hôpital Saint Joseph
Paris, France, 75674
CHU de Rouen 1 rue Germont service de chirurgie et digestive
Rouen, France, 76031
Germany
Koloproktologische Praxis
Kiel, Germany, 24105
Klinik für Allgemein- und Vizeralchirurgie
Ludwigsburg, Germany, 71640
Enddarmzentrum Mannheim
Mannheim, Germany, 68165
Italy
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
Norway
Akershus universitetssykehus
Nordbyhagen, Norway, 1474
Spain
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
Investigators
Study Director: Head of Medical Affairs Q-Med AB Q-Med AB
Principal Investigator: Tom Oresland, MD Akershus University Hospital, Lorenskog, Norway
  More Information

No publications provided

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01110681     History of Changes
Other Study ID Numbers: 33DA0605, Q-Med AB
Study First Received: April 9, 2010
Last Updated: November 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 28, 2014