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Study to Evaluate Solesta for Treatment of Fecal Incontinence

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Paul's Hospital
  • Helsingin yliopistollinen keskussairaala
  • CHU-Hotel-Dieu
  • Hôpital Saint Joseph
  • CHU de Rouen 1 rue Germont service de chirurgie et digestive
  • Koloproktologische Praxis
  • Klinik für Allgemein- und Vizeralchirurgie
  • Enddarmzentrum Mannheim
  • University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza
  • Univ. degli Studi di Padova Hospital Clinica Chirurgica
  • Policlinico Umberto I
  • Akershus universitetssykehus
  • Hospital Clinic Provincial
  • Hospital Juan Ramón Jiménez
  • Hospital General Univ. de Valéncia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Solesta

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Fecal Incontinence Episodes.
Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).
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.
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.
Number of Incontinence-free Days
Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).

Full Information

First Posted
April 9, 2010
Last Updated
August 24, 2022
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01110681
Brief Title
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

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solesta
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)
Other Intervention Name(s)
Solesta
Primary Outcome Measure Information:
Title
Responder Rate in Number of Fecal Incontinence Episodes
Description
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 Outcome Measure Information:
Title
Number of Fecal Incontinence Episodes.
Description
Number of fecal incontinence episodes, change from baseline (change in patient diary data at 12 month).
Time Frame
at 12 month - change from baseline
Title
Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score
Description
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
Title
Fecal Incontinence Quality of Life (FIQL)
Description
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
Title
Number of Incontinence-free Days
Description
Number of incontinence-free days, change from baseline (change in patient diary data at 12 month).
Time Frame
At 12 month- change from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Head of Medical Affairs Q-Med AB
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tom Oresland, MD
Organizational Affiliation
Akershus University Hospital, Lorenskog, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
Helsingin yliopistollinen keskussairaala
City
HUS
ZIP/Postal Code
00029
Country
Finland
Facility Name
CHU-Hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Saint Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
CHU de Rouen 1 rue Germont service de chirurgie et digestive
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Koloproktologische Praxis
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinik für Allgemein- und Vizeralchirurgie
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Enddarmzentrum Mannheim
City
Mannheim
ZIP/Postal Code
68165
Country
Germany
Facility Name
University of Bari - Coloproctological Unit of Bari Policinico di Bari Piazza
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Univ. degli Studi di Padova Hospital Clinica Chirurgica
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Akershus universitetssykehus
City
Nordbyhagen
ZIP/Postal Code
1474
Country
Norway
Facility Name
Hospital Clinic Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Juan Ramón Jiménez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Facility Name
Hospital General Univ. de Valéncia
City
Valéncia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

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Study to Evaluate Solesta for Treatment of Fecal Incontinence

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