Percutaneous tibial nerve stimulation of fecal incontinence: a multi center, randomized, placebo controlled study

Completed

• Conditions: Fecale incontinentie; Fecal incontinence

• Registration Number: NL-OMON33182
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

- Written informed consent
- Must be at least 18 years of age
- Fecal incontinence with solid or liquid stool causing disruption of the subject*s lifestyle
- Psychological stability as determined by the treating physician
- Willingness to commit to a rigid follow-up schedule and comply with the investigational plan
- Failed conservative therapy
- During treatment the patient exhibits an adequate motor and/or sensory response (flexion of toe and/or twinkling sensation)
- Is able to read and write

Exclusion Criteria

- Major internal and/or external sphincter defect (defined as >33% of the anal circumference)
- Fecal impaction
- Pacemaker, implanted defibrillator
- Pregnancy or intention to become pregnant
- Neurogenic or congenital disorders resulting in FI
- Inability to travel to the clinic twice a week

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of patients experiencing a * 50% decrease in incontinence<br /><br>episodes from baseline after 9 weeks of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI<br /><br>Score)<br /><br><br /><br>Mean change in Quality of Life scores in validated QoL questionnaires (SF-36,<br /><br>Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of<br /><br>life)<br /><br><br /><br>Subject*s and Physician*s Global Impression</p><br>