Study to Evaluate Solesta for Treatment of Fecal Incontinence

Galderma R&D115 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Fecal Incontinence

Interventions

Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (15)

St. Paul's Hospital

Vancouver, Canada

Helsingin yliopistollinen keskussairaala

HUS, Finland

CHU-Hotel-Dieu

Nantes, France

Outcomes

Primary Outcomes

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.

Time frame: 12 months after last treatment compared to baseline

Secondary Outcomes

Number of Fecal Incontinence Episodes.

Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).

Time frame: 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.

Time frame: 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.

Time frame: 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).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.