Study to Evaluate Solesta for Treatment of Fecal Incontinence

NCT01110681 | Completed Results

• 1 other identifier: 33DA0605, Q-Med AB
• Study Type: interventional
• Target: 115
• Locations: 7 countries
• Sites: 15

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.

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Fecal Incontinence Episodes.

  at 12 month - change from baseline

• Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score

  12 month - change from baseline

• Fecal Incontinence Quality of Life (FIQL)

  At 12 month - change from baseline

• Number of Incontinence-free Days

  At 12 month- change from baseline

Study Arms (1)

Solesta

EXPERIMENTAL

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.

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

Interventions

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

Also known as: Solesta

Solesta

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (15)

St. Paul's Hospital

Vancouver, V6Z1Y6, Canada

Location

Helsingin yliopistollinen keskussairaala

HUS, 00029, Finland

Location

CHU-Hotel-Dieu

Nantes, 44093, France

Location

Hôpital Saint Joseph

Paris, 75674, France

Location

CHU de Rouen 1 rue Germont service de chirurgie et digestive

Rouen, 76031, France

Location

Koloproktologische Praxis

Kiel, 24105, Germany

Location

Klinik für Allgemein- und Vizeralchirurgie

Ludwigsburg, 71640, Germany

Location

Enddarmzentrum Mannheim

Mannheim, 68165, Germany

Location

University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza

Bari, 70124, Italy

Location

Univ. degli Studi di Padova Hospital Clinica Chirurgica

Padua, 35128, Italy

Location

Policlinico Umberto I

Rome, 00161, Italy

Location

Akershus universitetssykehus

Nordbyhagen, 1474, Norway

Location

Hospital Clinic Provincial

Barcelona, 08036, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Hospital General Univ. de Valéncia

Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Q-Med AB

reception.SEUPP@galderma.com

+ 46 (0)18 4749000

Study Officials

• Head of Medical Affairs Q-Med AB

  Galderma R&D

  STUDY DIRECTOR

• Tom Oresland, MD

  Akershus University Hospital, Lorenskog, Norway

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 27, 2010
• Study Start: November 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2010
• Last Updated: August 26, 2022
• Results First Posted: February 28, 2019

Record last verified: 2013-12

Locations

CA (1); ES (3); FI (1); NO (1); DE (3); FR (3); IT (3)