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OpenTrials
Completed

NCT Number: NCT01110681

Study to Evaluate Solesta for 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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul's Hospital, Vancouver, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Other names: Solesta

Primary outcomes

  1. Responder Rate in Number of Fecal Incontinence Episodes

    Time frame: 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 outcomes

  1. Number of Fecal Incontinence Episodes.

    Time frame: at 12 month - change from baseline

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

  2. Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score

    Time frame: 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.

  3. Fecal Incontinence Quality of Life (FIQL)

    Time frame: 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.

  4. Number of Incontinence-free Days

    Time frame: At 12 month- change from baseline

    Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Apr 27, 2010
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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