Study to Evaluate Solesta for Treatment of Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110681
• Other study ID #: 33DA0605, Q-Med AB
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2013
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver
Finland	Helsingin yliopistollinen keskussairaala	HUS
France	CHU-Hotel-Dieu	Nantes
France	Hôpital Saint Joseph	Paris
France	CHU de Rouen 1 rue Germont service de chirurgie et digestive	Rouen
Germany	Koloproktologische Praxis	Kiel
Germany	Klinik für Allgemein- und Vizeralchirurgie	Ludwigsburg
Germany	Enddarmzentrum Mannheim	Mannheim
Italy	University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza	Bari
Italy	Univ. degli Studi di Padova Hospital Clinica Chirurgica	Padova
Italy	Policlinico Umberto I	Rome
Norway	Akershus universitetssykehus	Nordbyhagen
Spain	Hospital Clinic Provincial	Barcelona
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital General Univ. de Valéncia	Valéncia

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

Canada,  Finland,  France,  Germany,  Italy,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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