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

Not Applicable

Completed

Conditions: Fecal Incontinence

Interventions: Device: Sham Injection
Device: NASHA/Dx (Solesta) Gel

Registration Number: NCT00605826

Lead Sponsor: Bausch Health Americas, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 206

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blinded sham inject. at randomization	Sham Injection	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 injection of NASHA/Dx gel at randomization.	NASHA/Dx (Solesta) Gel	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 Inject. at Randomization + NASHA/Dx Gel at 6 mo.	NASHA/Dx (Solesta) Gel	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).
Blinded Sham Inject. at Randomization + NASHA/Dx Gel at 6 mo.	Sham Injection	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Are Responder50.	6 months after last blinded treatment	Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).
Percentage of Participants Who Are Responder25.	12 months after last treatment	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

Name	Time	Method
Number of Fecal Incontinence Episodes	up to 6 months after last treatment	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	up to 6 months after last treatment	The number of days with no fecal incontinence episodes (incontinence free days).
Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).	up to 6 months after last treatment	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).	up to 6 months after last treatment	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)

Trial Locations

Locations (13): Colon & Rectal Surgery Associates
🇺🇸
Minneapolis, Minnesota, United States
University of California, San Francisco, Center for Pelvic Physiology, Dept. of Surgery
🇺🇸
San Francisco, California, United States
Lahey Clinic, Department of Colon & Rectal Surgery
🇺🇸
Burlington, Massachusetts, United States
Salt Lake Research/Center for Colon Rectal Disease
🇺🇸
Salt Lake City, Utah, United States
University of South Florida College of Medicine, Tampa General Hospital
🇺🇸
Tampa, Florida, United States
Kirurgkliniken, Uppsala Akademiska Sjukhus
🇸🇪
Uppsala, Sweden
Kirurgmottagningen Universitetssjukhuset MAS
🇸🇪
Malmo, Sweden
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Castle Hill Hospital, Department of Academic Surgery
🇬🇧
Cottingham, East Yorkshire, United Kingdom
Kirurgmottagningen, Danderyds Sjukhus
🇸🇪
Stockholm, Sweden
St. Luke's/Roosevelt Hospital
🇺🇸
New York, New York, United States
Chirurgische Klinik Mit Poliklinik, FAU Erlangen-Nurnberg
🇩🇪
Erlangen, Germany
Colorectal Surgical Associates
🇺🇸
Houston, Texas, United States