NCT01130870

Brief Summary

The purpose of this study is to determine if subsensory stimulation (amplitude) will maintain same continence in patients treated with Sacral Nerve Stimulation (SNS) for faecal incontinence as stimulation with amplitude at sensory threshold.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

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

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

May 14, 2010

Last Update Submit

November 9, 2011

Conditions

Fecal Incontinence

Keywords

Fecal incontinenceSacral nerve stimulationQuality of lifeDR15.9 Incontinentia alva

Outcome Measures

Primary Outcomes (1)

  • Number of incontinence episodes Assess number of incontinence episodes.

    Assess number of incontinence episodes, by means of bowel habit diary. Four week bowel habit diary will be evaluated three times during the twelve-week protocol perioed.

    Will be assessed every four weeks during a twelve-week period

Secondary Outcomes (2)

  • Assess changes in anorectal volume and pressure with different amplitude.

    Will be assessed every four weeks during a twelve-week period

  • Assess Quality of life after decrease in stimulation amplitude.

    Will be assessed every four weeks during a twelve-week period

Study Arms (3)

Sensory threshold - Amplitude

ACTIVE COMPARATOR

Stimulation amplitude set at sensory threshold.

Device: Sensory Threshold

25% below sensory threshold - Amplitude

EXPERIMENTAL

Stimulation amplitude 75% of sensory threshold.

Device: 75% of sensory threshold - Amplitude

50% below sensory threshold - Amplitude

EXPERIMENTAL

Stimulation with amplitude set 50% below sensory threshold

Device: 50% of sensory threshold - Amplitude

Interventions

Sensory ThresholdDEVICE

Sacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.

Sensory threshold - Amplitude
75% of sensory threshold - AmplitudeDEVICE

Sacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.

25% below sensory threshold - Amplitude
50% of sensory threshold - AmplitudeDEVICE

Sacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.

50% below sensory threshold - Amplitude

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Informed consent
  • Idiopathic fecal incontinence or Fecal incontinence due to small sphincter defect(≤60 o)
  • fecal incontinence after primary/secondary sphincter repair
  • Permanent neuromodulator (medtronic InterStim / Interstim II) implanted for at least 12 weeks before entering the study.
  • Reduction in fecal incontinence episodes of at least 75% between baseline and latest follow up.(Bowel diary card) or 75% reduction of Wexner Inc. score.
  • Willing and competent to fill out diary cards

You may not qualify if:

  • Colorectal/proctological surgery since IPG-implant
  • Pregnancy
  • Anorectal Pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anal Physiology Laboratory, Surgical Research Section 900, Aarhus University Hospital

Aarhus, Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Duelund-Jakobsen J, Buntzen S, Lundby L, Laurberg S. Sacral nerve stimulation at subsensory threshold does not compromise treatment efficacy: results from a randomized, blinded crossover study. Ann Surg. 2013 Feb;257(2):219-23. doi: 10.1097/SLA.0b013e318269d493.

    PMID: 23001079DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2010

First Posted

May 26, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

DK(1)