Study to Evaluate Solesta for Treatment of Fecal Incontinence

Galderma

Status: Completed

Conditions: Fecal Incontinence

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110681

33DA0605, Q-Med AB

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Solesta

Experimental group

Description:

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.

Treatment:

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