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

A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Device: NASHA/Dx (Solesta) Gel; Device: Sham Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 910 54
    • Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg
• Sweden
  • Malmo, Sweden, 205 02
    • Kirurgmottagningen Universitetssjukhuset MAS
  • Stockholm, Sweden, 182 88
    • Kirurgmottagningen, Danderyds Sjukhus
  • Uppsala, Sweden, 751 85
    • Kirurgkliniken, Uppsala Akademiska Sjukhus
• United Kingdom
  • East Yorkshire
    • Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
      • Castle Hill Hospital, Department of Academic Surgery
• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery
  • Florida
    • Tampa, Florida, United States, 33601
      • University of South Florida College of Medicine, Tampa General Hospital
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic, Department of Colon & Rectal Surgery
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • Colon & Rectal Surgery Associates
  • New York
    • New York, New York, United States, 10019
      • St. Luke's/Roosevelt Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Texas
    • Houston, Texas, United States, 77054
      • Colorectal Surgical Associates
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Salt Lake Research/Center for Colon Rectal Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blinded injection of NASHA/Dx gel at randomization.; 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).	Device: NASHA/Dx (Solesta) Gel; Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.; Other Names: Solesta
Sham Comparator: Blinded sham inject. at randomization; 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).	Device: Sham Injection; Sham injection at the start of the blinded phase.
Other: Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo.; 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).	Device: NASHA/Dx (Solesta) Gel; Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.; Other Names: Solesta; Device: Sham Injection; Sham injection at the start of the blinded phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Are Responder50.	Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).	6 months after last blinded treatment
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).	12 months after last treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 6 months after last treatment
Number of Incontinence Free Days	The number of days with no fecal incontinence episodes (incontinence free days).	up to 6 months after last treatment
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.	up to 6 months after last treatment
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)	up to 6 months after last treatment

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Collaborators: Galderma R&D; Oceana Therapeutics, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2006
• Primary Completion (Actual): November 23, 2009
• Study Completion (Actual): November 23, 2009

Study Registration Dates

• First Submitted: January 9, 2008
• First Submitted That Met QC Criteria: January 30, 2008
• First Posted (Estimate): January 31, 2008

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: 33DA0404