Pilot Study of NASHA/Dx Gel for Fecal Incontinence

Uppsala University Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Fecal Incontinence

Treatments: Device: Solesta (Nasha/Dx)

Study type: Interventional

Funder types: Other

Identifiers

NCT00971269

EPN 2008/066

Details and patient eligibility

About

The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fecal incontinence with at least 2 episodes/week
2. Symptom duration at least one year
3. Failed attempt of conservative therapy
4. Age 18-80
5. Written informed consent
6. Available for follow-up
7. Fully compliant with protocol

Exclusion criteria

1. Active inflammatory bowel disease
2. Total external sphincter defect at ultrasound and clinical examination
3. Bleeding diathesis or anticoagulant therapy
4. Rectal prolapse or intussusceptions
5. Present anal sepsis
6. Anorectal implants
7. Recent anorectal surgery (within 6 months)
8. Rectal anastomosis
9. Pregnancy, postpartum (one year) or breast feeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)