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Pilot Study of NASHA/Dx Gel for Fecal Incontinence

U

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)

Trial contacts and locations

1

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Central trial contact

Wilhelm JR Graf, MD PhD

Data sourced from clinicaltrials.gov

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