Study to Evaluate Solesta for Treatment of Fecal Incontinence

An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada, V6Z1Y6
    • St. Paul's Hospital
• Finland
  • HUS, Finland, 00029
    • Helsingin Yliopistollinen Keskussairaala
• France
  • Nantes, France, 44093
    • CHU-Hotel-Dieu
  • Paris, France, 75674
    • Hopital Saint Joseph
  • Rouen, France, 76031
    • CHU de Rouen 1 rue Germont service de chirurgie et digestive
• Germany
  • Kiel, Germany, 24105
    • Koloproktologische Praxis
  • Ludwigsburg, Germany, 71640
    • Klinik für Allgemein- und Vizeralchirurgie
  • Mannheim, Germany, 68165
    • Enddarmzentrum Mannheim
• Italy
  • Bari, Italy, 70124
    • University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza
  • Padova, Italy, 35128
    • Univ. degli Studi di Padova Hospital Clinica Chirurgica
  • Rome, Italy, 00161
    • Policlinico Umberto I
• Norway
  • Nordbyhagen, Norway, 1474
    • Akershus Universitetssykehus
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Provincial
  • Huelva, Spain, 21005
    • Hospital Juan Ramon Jimenez
  • Valéncia, Spain, 46014
    • Hospital General Univ. de Valéncia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate in Number of Fecal Incontinence Episodes	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.	12 months after last treatment compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Fecal Incontinence Episodes.	Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).	at 12 month - change from baseline
Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score	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.	12 month - change from baseline
Fecal Incontinence Quality of Life (FIQL)	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.	At 12 month - change from baseline
Number of Incontinence-free Days	Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).	At 12 month- change from baseline

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 9, 2010
• First Submitted That Met QC Criteria: April 22, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 33DA0605, Q-Med AB