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

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

Exclusion criteria

  • Active inflammatory bowel disease
  • Total external sphincter defect at ultrasound and clinical examination
  • Bleeding diathesis or anticoagulant therapy
  • Rectal prolapse or intussusceptions
  • Present anal sepsis
  • Anorectal implants
  • Recent anorectal surgery (within 6 months)
  • Rectal anastomosis
  • 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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