Sacral Nerve Stimulation for Anal Incontinence and Bowel Control

MedtronicNeuro9 sites in 8 countries140 target enrollmentNovember 1998

ConditionsFecal Incontinence and Constipation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Fecal Incontinence and Constipation
Sponsor: MedtronicNeuro
Enrollment: 140
Locations: 9
Primary Endpoint: 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 emptying
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

November 1998

End Date

September 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MedtronicNeuro

Responsible Party

Sponsor

Eligibility Criteria

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:

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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 emptying

Time Frame: Annually

Secondary Outcomes

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)