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

Fecal Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605826
• Other study ID #: 33DA0404
• Status: Completed
• Phase: N/A
• Start date: September 7, 2006
• Est. completion date: November 23, 2009

Study information

• Verified date: August 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: November 23, 2009
• Est. primary completion date: November 23, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• NASHA/Dx (Solesta) Gel
Injection of 4 x 1ml of NASHA/Dx Gel at the start of the blinded phase.
• Sham Injection
Sham injection at the start of the blinded phase.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.	Oceana Therapeutics, Inc., Q-Med AB

Countries where clinical trial is conducted

United States,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Number of Incontinence Free Days	The number of days with no fecal incontinence episodes (incontinence free days).	up to 6 months after last treatment
Secondary	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
Secondary	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