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
  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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974909

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
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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 July 28, 2014