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

Bausch Health

Status: Completed

Conditions: Fecal Incontinence

Treatments: Device: NASHA/Dx (Solesta) Gel; Device: Sham Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00605826

33DA0404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 3 patient groups

Blinded injection of NASHA/Dx gel at randomization.

Experimental group

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).

Treatment:

Device: NASHA/Dx (Solesta) Gel

Blinded sham inject. at randomization

Sham Comparator group

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).

Treatment:

Device: Sham Injection

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

Other group

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).

Treatment:

Device: Sham Injection

Device: NASHA/Dx (Solesta) Gel