Safety and Efficacy of Anorectal Application of Dx-gel for Treatment of Anal Incontinence

Uppsala University Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Fecal Incontinence

Treatments: Procedure: Anal injection of Nasha Dx

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01380132

Nasha Dx Pilot study

03 464 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether anorectal application of Nasha Dx is safe and effective for treatment of anal incontinence.

Full description

Patients not fully improved after 1:st injection were offered reinjection after 4-6 weeks.

Enrollment: 35 patients

Sex

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
• Age 18-80
• Available for follow-up for the duration of the study
• Written informed consent.

Exclusion criteria

• Sphincter defect visible on anal ultrasound.
• Pregnancy.
• Rectal prolapse or inflammatory bowel disease.
• Recent (within 6 months) anal surgery except for haemorrhoids.
• Anorectal sepsis.
• Anticoagulant medication or bleeding diathesis.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Anal injection of Nasha Dx

Experimental group

Treatment:

Procedure: Anal injection of Nasha Dx