Percutaneous Tibial Nerve Stimulation in the Treatment of Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974909
• Other study ID #: 09-2-079
• Secondary ID: NL 28955.068.09M
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2009
• Last updated: August 25, 2015
• Start date: October 2009
• Est. completion date: August 2015

Study information

• Verified date: September 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 2015
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Urgent PC neuromodulation system
Urgent PC neuromodulation system
• Urgent PC neuromodulation system
Urgent PC neuromodulation system (sham)

Locations

Country	Name	City	State
France	CCDE - IMAD - Hôtel-Dieu	Nantes
Italy	Università degli Studi di Roma "La Sapienza"	Roma
Netherlands	Maastricht university medical center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Countries where clinical trial is conducted

France,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes