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A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NASHA/Dx (Solesta) Gel
Sham Injection
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-75 years of age, male or female.
  • Screening fecal incontinence severity score (CCFIS).
  • Fecal incontinence episodes over a 14-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 (IBD).
  • Immunodeficiency or receiving immunosuppressive therapy.
  • Malignancies in remission for less than 2 years prior to the study.
  • Bleeding disorders or receiving anticoagulant therapy.
  • Chemotherapy within the last 12 months prior to the study.
  • Prior Pelvic radiotherapy.
  • Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
  • Women within one year post partum.
  • Participation in any other clinical study within 3 month prior to the study.
  • Hypersensitivity to hyaluronic acid containing products.
  • Other severe conditions or in other ways unsuitable to participate according to investigator judgement.

Sites / Locations

  • University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery
  • University of South Florida College of Medicine, Tampa General Hospital
  • Lahey Clinic, Department of Colon & Rectal Surgery
  • Colon & Rectal Surgery Associates
  • St. Luke's/Roosevelt Hospital
  • Cleveland Clinic Foundation
  • Colorectal Surgical Associates
  • Salt Lake Research/Center for Colon Rectal Disease
  • Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg
  • Kirurgmottagningen Universitetssjukhuset MAS
  • Kirurgmottagningen, Danderyds Sjukhus
  • Kirurgkliniken, Uppsala Akademiska Sjukhus
  • Castle Hill Hospital, Department of Academic Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Blinded injection of NASHA/Dx gel at randomization.

Blinded sham inject. at randomization

Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo.

Arm Description

Blinded injection of NASHA/Dx (Solesta) Gel. For each treatment, a series of 4 equally spaced injections with 1 mL of Solesta into the anal canal. Subjects will be followed for 6 months during the blinded phase. During a subsequent open phase, these subjects will be followed to Month 36 (ie, for an additional 30 months).

Blinded sham injection (needle stick with empty syringes). For each treatment, a series of 4 equally spaced Sham injections (needle sticks) into the anal canal. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months).

Blinded sham injection at randomization. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months).

Outcomes

Primary Outcome Measures

Percentage of Participants Who Are Responder50.
Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).
Percentage of Participants Who Are Responder25.
Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25).

Secondary Outcome Measures

Number of Fecal Incontinence Episodes
The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits.
Number of Incontinence Free Days
The number of days with no fecal incontinence episodes (incontinence free days).
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).
The disease-specific Fecal Incontinence Quality of Life (FIQL) questionnaire is designed to capture the impact of treatment on quality of life for participants suffering from fecal incontinence as it pertains to 4 domains: Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The more the subject is affected by fecal incontinence the lower the value. Hence, a positive change from baseline indicates improvement. Scores range from 1 to 4.
Cleveland Clinic Florida Incontinence Score (CCFIS).
Cleveland Clinic Florida Incontinence Score (CCFIS) score was based on a participant interview using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage and lifestyle alterations during the past month. The score ranged from 0 (perfect) to 20 (complete incontinence)

Full Information

First Posted
January 9, 2008
Last Updated
August 4, 2020
Sponsor
Bausch Health Americas, Inc.
Collaborators
Oceana Therapeutics, Inc., Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00605826
Brief Title
A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence
Official Title
A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 7, 2006 (Actual)
Primary Completion Date
November 23, 2009 (Actual)
Study Completion Date
November 23, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Oceana Therapeutics, Inc., Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.
Detailed Description
Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx. Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study.

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
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blinded injection of NASHA/Dx gel at randomization.
Arm Type
Experimental
Arm Description
Blinded injection of NASHA/Dx (Solesta) Gel. For each treatment, a series of 4 equally spaced injections with 1 mL of Solesta into the anal canal. Subjects will be followed for 6 months during the blinded phase. During a subsequent open phase, these subjects will be followed to Month 36 (ie, for an additional 30 months).
Arm Title
Blinded sham inject. at randomization
Arm Type
Sham Comparator
Arm Description
Blinded sham injection (needle stick with empty syringes). For each treatment, a series of 4 equally spaced Sham injections (needle sticks) into the anal canal. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months).
Arm Title
Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo.
Arm Type
Other
Arm Description
Blinded sham injection at randomization. Subjects will be followed for 6 months during the blinded phase. Sham-treated subjects have the option to receive open-label injection of NASHA/Dx (Solesta) Gel at the 6-month time point following completion of the blinded phase (ie, blinded sham injection at randomization + NASHA/Dx Gel at 6 months). Following injection of NASHA/Dx gel at the start of the open phase, these subjects will be followed to Month 30 (ie, for an additional 24 months).
Intervention Type
Device
Intervention Name(s)
NASHA/Dx (Solesta) Gel
Other Intervention Name(s)
Solesta
Intervention Description
Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
Intervention Type
Device
Intervention Name(s)
Sham Injection
Intervention Description
Sham injection at the start of the blinded phase.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Are Responder50.
Description
Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).
Time Frame
6 months after last blinded treatment
Title
Percentage of Participants Who Are Responder25.
Description
Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25).
Time Frame
12 months after last treatment
Secondary Outcome Measure Information:
Title
Number of Fecal Incontinence Episodes
Description
The number of incontinence episodes collected from a participant incontinence diary spanning a period of 14 days prior to each of the study visits.
Time Frame
up to 6 months after last treatment
Title
Number of Incontinence Free Days
Description
The number of days with no fecal incontinence episodes (incontinence free days).
Time Frame
up to 6 months after last treatment
Title
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).
Description
The disease-specific Fecal Incontinence Quality of Life (FIQL) questionnaire is designed to capture the impact of treatment on quality of life for participants suffering from fecal incontinence as it pertains to 4 domains: Lifestyle, Coping/Behavior, Depression/Self perception and Embarrassment. The more the subject is affected by fecal incontinence the lower the value. Hence, a positive change from baseline indicates improvement. Scores range from 1 to 4.
Time Frame
up to 6 months after last treatment
Title
Cleveland Clinic Florida Incontinence Score (CCFIS).
Description
Cleveland Clinic Florida Incontinence Score (CCFIS) score was based on a participant interview using standardized questions regarding incidence and type of incontinence (solid, liquid or gas), pad usage and lifestyle alterations during the past month. The score ranged from 0 (perfect) to 20 (complete incontinence)
Time Frame
up to 6 months after last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-75 years of age, male or female. Screening fecal incontinence severity score (CCFIS). Fecal incontinence episodes over a 14-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 (IBD). Immunodeficiency or receiving immunosuppressive therapy. Malignancies in remission for less than 2 years prior to the study. Bleeding disorders or receiving anticoagulant therapy. Chemotherapy within the last 12 months prior to the study. Prior Pelvic radiotherapy. Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study. Women within one year post partum. Participation in any other clinical study within 3 month prior to the study. Hypersensitivity to hyaluronic acid containing products. Other severe conditions or in other ways unsuitable to participate according to investigator judgement.
Facility Information:
Facility Name
University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of South Florida College of Medicine, Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33601
Country
United States
Facility Name
Lahey Clinic, Department of Colon & Rectal Surgery
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Colon & Rectal Surgery Associates
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
St. Luke's/Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Colorectal Surgical Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Salt Lake Research/Center for Colon Rectal Disease
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg
City
Erlangen
ZIP/Postal Code
910 54
Country
Germany
Facility Name
Kirurgmottagningen Universitetssjukhuset MAS
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Kirurgmottagningen, Danderyds Sjukhus
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Kirurgkliniken, Uppsala Akademiska Sjukhus
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Castle Hill Hospital, Department of Academic Surgery
City
Cottingham
State/Province
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21420555
Citation
Graf W, Mellgren A, Matzel KE, Hull T, Johansson C, Bernstein M; NASHA Dx Study Group. Efficacy of dextranomer in stabilised hyaluronic acid for treatment of faecal incontinence: a randomised, sham-controlled trial. Lancet. 2011 Mar 19;377(9770):997-1003. doi: 10.1016/S0140-6736(10)62297-0.
Results Reference
derived

Learn more about this trial

A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of Fecal Incontinence

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