Clinical trial NCT01110681: Study to Evaluate Solesta for Treatment of Fecal Incontinence
Official title: An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Responder Rate in Number of Fecal Incontinence Episodes
timeFrame: 12 months after last treatment compared to baseline
Secondary outcomes:
measure: Number of Fecal Incontinence Episodes.
timeFrame: at 12 month - change from baseline
measure: Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score
timeFrame: 12 month - change from baseline
measure: Fecal Incontinence Quality of Life (FIQL)
timeFrame: At 12 month - change from baseline
measure: Number of Incontinence-free Days
timeFrame: At 12 month- change from baseline
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
city: HUS
country: Finland
facility: Helsingin yliopistollinen keskussairaala
city: Nantes
country: France
facility: CHU-Hotel-Dieu
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Rouen
country: France
facility: CHU de Rouen 1 rue Germont service de chirurgie et digestive
city: Kiel
country: Germany
facility: Koloproktologische Praxis
city: Ludwigsburg
country: Germany
facility: Klinik für Allgemein- und Vizeralchirurgie
city: Mannheim
country: Germany
facility: Enddarmzentrum Mannheim
city: Bari
country: Italy
facility: University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza
city: Padova
country: Italy
facility: Univ. degli Studi di Padova Hospital Clinica Chirurgica
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Nordbyhagen
country: Norway
facility: Akershus universitetssykehus
city: Barcelona
country: Spain
facility: Hospital Clinic Provincial
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Valéncia
country: Spain
facility: Hospital General Univ. de Valéncia
Study officials:
affiliation: Galderma R&D
name: Head of Medical Affairs Q-Med AB
role: STUDY_DIRECTOR
affiliation: Akershus University Hospital, Lorenskog, Norway
name: Tom Oresland, MD
role: PRINCIPAL_INVESTIGATOR
References: