Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence
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Purpose
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 vary from 13-19%. There are variable treatment options depending on the patient and the etiology of the FI. Dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well as surgical interventions are currently used to treat FI.
A promising current treatment is Percutaneous Tibial Nerve Stimulation (PTNS). The nerves in the spine that control bowel function also have branches which go to the ankle. Stimulating these nerves in the ankle has shown to be an effective treatment for FI in the short-term. The treatment has been shown to be safe and well tolerated by subjects with almost no morbidity in prior urology trials.
Objective of the study:
The objective of this study is to show that the results of PTNS are based on the treatment of electrical stimulation and not on a placebo effect with a sham treatment.
Study design:
This study is a multicenter, single-blinded, randomized, placebo-controlled trial.
Primary study parameters/outcome of the study:
The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment.
Secondary study parameters/outcome of the study (if applicable):
Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score)
Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life)
Subject's and Physician's Global Impression
| Condition | Intervention | Phase |
|---|---|---|
|
Fecal Incontinence |
Device: Urgent PC neuromodulation system |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence: a Multi-center, Randomized, Placebo Controlled Study |
- The percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment and at six and twelve months follow-up. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
- Mean change in the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FI Score) at 6 weeks and 9 weeks of treatment and at six and twelve months follow-up. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Mean change in Quality of Life scores in validated QoL questionnaires (SF-36, Digestive Health Status Instrument (DHSI), and Fecal Incontinence Quality of life) at 6 weeks and 9 weeks of treatment and at six and twelve months follow-up. [ Time Frame: one year ] [ Designated as safety issue: No ]
- Subject's and Physician's Global Impression at 6 weeks and 9 weeks of treatment and at six and twelve months follow-up. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 56 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treatment group
Treatment group
|
Device: Urgent PC neuromodulation system
Urgent PC neuromodulation system
|
|
Sham Comparator: sham group
Sham group
|
Device: Urgent PC neuromodulation system
Urgent PC neuromodulation system (sham)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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 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
Contacts and Locations| France | |
| CCDE - IMAD - Hôtel-Dieu | |
| Nantes, France, F - 44093 | |
| Italy | |
| Università degli Studi di Roma "La Sapienza" | |
| Roma, Italy, 00185 | |
| Netherlands | |
| Maastricht university medical center | |
| Maastricht, Limburg, Netherlands, 6229 HX | |
| Principal Investigator: | Cornelius Baeten, prof phd md | Maastricht University Medical Center |
More Information
No publications provided
| Responsible Party: | Cornelius Baeten, Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00974909 History of Changes |
| Other Study ID Numbers: | 09-2-079, NL 28955.068.09, MEC 09-2-079 |
| Study First Received: | September 8, 2009 |
| Last Updated: | September 2, 2010 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
Fecal incontinence |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013