Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00974909
First received: September 8, 2009
Last updated: September 2, 2010
Last verified: September 2010

September 8, 2009
September 2, 2010
October 2009
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00974909 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence
Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence: a Multi-center, Randomized, Placebo Controlled Study

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Fecal Incontinence
  • Device: Urgent PC neuromodulation system
    Urgent PC neuromodulation system
  • Device: Urgent PC neuromodulation system
    Urgent PC neuromodulation system (sham)
  • Active Comparator: Treatment group
    Treatment group
    Intervention: Device: Urgent PC neuromodulation system
  • Sham Comparator: sham group
    Sham group
    Intervention: Device: Urgent PC neuromodulation system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
56
Not Provided
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Netherlands
 
NCT00974909
09-2-079, NL 28955.068.09, MEC 09-2-079
Yes
Cornelius Baeten, Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Principal Investigator: Cornelius Baeten, prof phd md Maastricht University Medical Center
Maastricht University Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP