NCT01528995

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

3.6 years

First QC Date

January 26, 2012

Last Update Submit

June 20, 2016

Conditions

Fecal Incontinence

Keywords

fecal incontinenceanal incontinenceobstetric sphincter injuriesOASISdouble incontinenceurinary incontinencesexual functionsacral nerve modulationsacral nerve stimulationInterstimanal bulking injectionsPermacol

Outcome Measures

Primary Outcomes (1)

  • change in St Marks incontinence score

    Vaizey Incontinence Score A scale from 0-24 where 0 = perfect continence and 24 = complete incontinence. 3, 6 and 12 months

    6 month after treatment

Secondary Outcomes (4)

  • change in number of fecal incontinence and urgency episodes per week

    3 and 6 month after treatment

  • change in Quality of life assessment (Rockwood- Fecal incontinence quality of life )

    3 and 6 month

  • change in urinary incontinence score (ICIQ-UI SF)

    3 and 6 month

  • change in sexual function

    3 and 6 months

Study Arms (3)

sacral nerve modulation

ACTIVE COMPARATOR

Implantation of Interstim II-3058 impulse generator after positive PNE test. Randomized controlled trial.

Device: Medtronic Interstim II-3058

anal bulking agents

ACTIVE COMPARATOR

anal injection with Permacol after positive PNE test. Randomized controlled trial.

Procedure: Anal bulking injection

Anal bulking agents

ACTIVE COMPARATOR

Anal injection with Permacol after negative PNE test. cohort study.

Procedure: Anal bulking injection

Interventions

Medtronic Interstim II-3058DEVICE

impulse generator

sacral nerve modulation
Anal bulking injectionPROCEDURE

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

Anal bulking agentsanal bulking agents

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fecal incontinence after OASIS
  • St Marks score \> 8
  • failure of conservative treatment

You may not qualify if:

  • pregnancy
  • immunosuppressed
  • former major pelvic surgery or irradiation
  • Rectal prolapse
  • complex fistula
  • IBD
  • Lateral sphincterotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Colorectal Surgery, University Hospital of North Norway

Tromsø, Troms, 9037, Norway

Location

MeSH Terms

Conditions

Fecal IncontinenceEncopresisUrinary Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental DisordersUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological Manifestations

Study Officials

  • Stig Norderval, PHD MD

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

February 8, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations

NO(1)