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Completed

NCT Number: NCT00974909

Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence

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

Completed

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CCDE - IMAD - Hôtel-Dieu, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urgent PC Neuromodulation System

Device

Urgent PC neuromodulation system

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence: a Multi-center, Randomized, Placebo Controlled Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2015
First posted
Sep 11, 2009
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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