Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence

NCT00974909 | Completed Phase 3 DMC

• 3 other identifiers: 09-2-079NL 28955.068.09MEC 09-2-079
• Study Type: interventional
• Target: 59
• Locations: 3 countries
• Sites: 3

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 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

Conditions

Fecal Incontinence

Keywords

Fecal incontinence

Outcome Measures

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.

  9 weeks

Secondary Outcomes (3)

• 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.

  one year

• 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.

  one year

• Subject's and Physician's Global Impression at 6 weeks and 9 weeks of treatment and at six and twelve months follow-up.

  one year

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Treatment group

Device: Urgent PC neuromodulation system

sham group

SHAM COMPARATOR

Sham group

Device: Urgent PC neuromodulation system

Interventions

Urgent PC neuromodulation system DEVICE

Urgent PC neuromodulation system

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (3)

CCDE - IMAD - Hôtel-Dieu

Nantes, F - 44093, France

Location

Università degli Studi di Roma "La Sapienza"

Roma, 00185, Italy

Location

Maastricht university medical center

Maastricht, Limburg, 6229 HX, Netherlands

Location

Related Publications (1)

• van der Wilt AA, Giuliani G, Kubis C, van Wunnik BPW, Ferreira I, Breukink SO, Lehur PA, La Torre F, Baeten CGMI. Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence. Br J Surg. 2017 Aug;104(9):1167-1176. doi: 10.1002/bjs.10590.

  PMID: 28703936 DERIVED

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Cornelius Baeten, prof phd md

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 11, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: August 1, 2015
• Last Updated: August 26, 2015

Record last verified: 2010-09

Locations

NL (1); IT (1); FR (1)