Study to Evaluate Solesta for Treatment of Fecal Incontinence

Not Applicable

Completed

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

• Registration Number: NCT01110681
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-11
• Study First Submitted: 2010-04-09
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-27
• Study Completion: 2010-12
• Status Verified: 2013-12
• Results First Submitted: 2013-12-19
• Results First Submitted QC: 2018-10-17
• Results First Posted: 2019-02-28
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solesta	Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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.
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.
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).

Trial Locations

Locations (15)

St. Paul's Hospital; 🇨🇦 Vancouver, Canada

Koloproktologische Praxis; 🇩🇪 Kiel, Germany

CHU-Hotel-Dieu; 🇫🇷 Nantes, France

Helsingin yliopistollinen keskussairaala; 🇫🇮 HUS, Finland

Hôpital Saint Joseph; 🇫🇷 Paris, France

CHU de Rouen 1 rue Germont service de chirurgie et digestive; 🇫🇷 Rouen, France

Enddarmzentrum Mannheim; 🇩🇪 Mannheim, Germany

Klinik für Allgemein- und Vizeralchirurgie; 🇩🇪 Ludwigsburg, Germany

Akershus universitetssykehus; 🇳🇴 Nordbyhagen, Norway

Univ. degli Studi di Padova Hospital Clinica Chirurgica; 🇮🇹 Padova, Italy

University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza; 🇮🇹 Bari, Italy

Policlinico Umberto I; 🇮🇹 Rome, Italy

Hospital Clinic Provincial; 🇪🇸 Barcelona, Spain

Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Spain

Hospital General Univ. de Valéncia; 🇪🇸 Valéncia, Spain