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Treatment of Fecal Incontinence After Obstetric Anal Sphincter Injuries

NCT01528995 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2016-06-21

No results posted yet for this study

Summary

Fecal incontinence (FI), the involuntary loss of solid or liquid stool, is a stigmatising condition. It can have a distressing impact and restriction on quality of life. Obstetric-related fecal incontinence may occur early after childbirth. Previous obstetric injury is a major cause of fecal incontinence in older women.

When conservative treatment fails, surgery may be an option. Both sacral nerve modulation and anal bulking injections is minimal invasive surgical alternatives. Step one in SNM is a trial period of temporary stimulation. If the test is successful, the patient can have an implantable stimulator (step 2). Transanal submucosal bulking injection of collagen is also a possible treatment option and can be an effective treatment for faecal incontinence.

The purpose of this study is to compare the efficacy of sacral nerve stimulation to anal bulking injections in women with fecal incontinence after obstetric sphincter injuries (OASIS), through a multicenter blinded, randomized controlled trial.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Medtronic Interstim II-3058

impulse generator

PROCEDURE

Anal bulking injection

Permacol injection: four submucosal injections are administered at the 12, 3, 6 and 9 o'clock positions, above the level of the dentate line. The injection produces a bulge in the mucosa

Sponsors & Collaborators

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Stig Norderval, PHD MD · University Hospital of North Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01528995 on ClinicalTrials.gov