Status:
COMPLETED
Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Fecal Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Background of the study: Fecal incontinence is a complex problem. The social consequences of this problem result in a lower quality of life. The exact prevalence of FI is unknown, literature reports ...
Eligibility Criteria
Inclusion
- 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 treating physician
- Willingness to commit to a rigid follow-up schedule and comply with the investigational plan
- Failed conservative therapy (i.e. dietary and behavioural modification, biofeedback techniques and exercises for pelvic floor muscle retraining)
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00974909
Start Date
October 1 2009
End Date
August 1 2015
Last Update
August 26 2015
Active Locations (3)
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1
CCDE - IMAD - Hôtel-Dieu
Nantes, France, F - 44093
2
Università degli Studi di Roma "La Sapienza"
Roma, Italy, 00185
3
Maastricht university medical center
Maastricht, Limburg, Netherlands, 6229 HX