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Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00200005
Acronym
MDT-301
Enrollment
140
Registered
2005-09-20
Start date
1998-11-30
Completion date
2012-09-30
Last updated
2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence and Constipation

Keywords

Slow transit constipation, Fecal incontinence, Constipation, Idiopathic slow transit constipation, Chronic constipation

Brief summary

Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation

Interventions

DEVICEType: Implantable neurostimulator; InterStim

Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.

Sponsors

MedtronicNeuro
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

140 patients (7 study groups, up to 20 implanted patients per study group) Fecal Incontinence groups: Main Inclusion Criteria: * Fecal incontinence (defined as incontinence to solid or liquid stool \> 1 / week); * Failed biofeedback or medical therapy; Groups 1 - 5 patients with: * Group 1) Circumferentially intact external anal sphincter, no previous surgery; * Group 2) Circumferentially intact external anal sphincter after surgical repair; * Group 3) Rectal prolapse repaired with a rectopexy; * Group 4) Spinal injury including disc prolapse; * Group 5) Sigmoid or partial rectal resection with colorectal or coloanal anastomosis Constipation groups: Main Inclusion Criteria: * Chronic constipation (defined as \</= 2 weekly bowel movements; and/or \>25% of bowel movements required straining; and/or \>25% of bowel movements patient did not feel empty afterwards) with symptoms more than 1 year * Failed biofeedback or medical therapy; Groups 6 - 7 patients with: * Group 6) Idiopathic slow transit constipation as proven on colonic transit studies; * Group 7) Normal colonic transit studies but chronic constipation due to either pelvic floor dysfunction or disordered defecation.

Design outcomes

Primary

MeasureTime frame
FI - number of FI episodes per week and/or number of days with FI per week. Constipation - number of bowel movements per week; &/or decrease defecations requiring straining; &/or decrease defecations where there was incomplete emptyingAnnually

Secondary

MeasureTime frame
FI-number of days with staining/week;urgency with continent bowel movements; Improvement in QOL;* Improvement in anal canal pressure. Constipation - Improvement in Wexner constipation score; QOL.Annually

Countries

Austria, Denmark, Germany, Netherlands, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026