Tibial Nerve Stimulation in Combination With Biofeedback

August 30, 2016 updated by: Jenny Sjödahl, University Hospital, Linkoeping

Percutaneous Tibial Nerve Stimulation in Combination With Biofeedback in Patients With Fecal Incontinence - A Randomized Controlled Trial

Background: Fecal incontinence (FI) affects 2-13% of an adult general population. The prevalence increases with age, and after 50 years of age prevalence rates up to 26% in women have been reported. Quality of life in patients with FI is decreased considerably, in a similar extent as in patients with ulcerative colitis in relapse.

Management of FI usually involves a stepwise approach; beginning with more conservative strategies and moving on to more appropriately tailored medications, bowel-retraining, biofeedback and psychosocial support. Although a combination of these treatment alternatives often improves symptoms they are not always successfully. Neuromodulation is a relatively new treatment modality for FI that is based on recruitment of residual anorectal neuromuscular function pertinent to continence by electrical stimulation of the peripheral nerve supply. Sacral Nerve Stimulation (SNS) is one type of neuromodulation and it employs direct electrical stimulation of the sacral nerves. Recently an alternative neuromodulation technique to SNS has been developed in treating FI i.e. tibial nerve stimulation. The tibial nerve contains afferent and efferent fibers originating from the forth and the fifth lumbar nerves and the first, second and third sacral nerves. Thus, stimulation of the tibial nerve may lead to changes in anorectal neuromuscular function similar to those observed with SNS but without the need of a permanent surgically implanted device. Tibial nerve stimulation is therefore an attractive treatment alternative for FI patients since the treatment is well-tolerated and treatment results have been very promising.

Aim: The overall aim is to measure the effect of percutaneous tibial nerve stimulation (PTNS) in combination with biofeedback on symptoms in consecutive FI patients compared with biofeedback alone. The investigators also aim to study which FI patients have most profit of the addition of PTNS.

Methods: The study will take place at the Pelvic Floor Unit, department of Gastroenterology, University Hospital Linköping. Prior to the first visit to the hospital a symptom diary will be mailed to the FI patients and they are instructed to record their FI symptoms, bowel habits and gastrointestinal symptoms prospectively on a 24-hour diary during 2 weeks. Before consideration of enrolment into the study, gastroenterologists assess all the patients' medical history and perform a physical examination. Subjects will also have an endoanal ultrasonography and the investigators will measure rectal volumes, sensational thresholds and anal sphincter function.

FI patients who fulfil inclusion criteria will then be randomly assigned to either PTNS in combination with biofeedback or biofeedback alone. The treatment will be performed by physiotherapists.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 58185
        • Recruiting
        • Pelvic floor unit, University Hospital in Linköping
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18 years of age with fecal incontinence for more than 6 months
  • Patients with at least one or more episodes of fecal incontinence during a period of 2 weeks as recorded by bowel function diary
  • Patients from whom written consent was obtained

Exclusion Criteria:

  • Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
  • Presence of neurological diseases or peripheral vascular disease
  • Uncontrolled diabetes mellitus
  • Congenital anorectal malformations
  • Colorectal or gastrointestinal surgery ≤24 months
  • Presence of external full-thickness rectal prolapse
  • Inflammatory bowel disease
  • Chronic diarrhoea
  • Use of tibial nerve or sacral nerve stimulations
  • Ongoing pregnancy
  • Any malignant disease
  • Pacemaker
  • Ongoing or earlier treatment with sacral- or tibial nerve stimulation
  • Chronic varicose ulcer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Standard treatment
Behavioral: Biofeedback
Drug: Loperamide
Drug: Stool bulking agent (sterculia or ispaghula husk)
EXPERIMENTAL: PTNS in addition to standard treatment
Behavioral: Biofeedback
Drug: Loperamide
Drug: Stool bulking agent (sterculia or ispaghula husk)
Other: PTNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in fecal leakage episodes with a symptom diary
Time Frame: Change from baseline in fecal leakage episodes at 12 weeks (post-treatment), change from baseline in fecal lekage episodes at 12 months and 24 months
Change from baseline in fecal leakage episodes at 12 weeks (post-treatment), change from baseline in fecal lekage episodes at 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Principal Investigator: Jenny Sjödahl, PhD, RPT, University Hospital in Linkoeping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ANTICIPATED)

March 1, 2018

Study Completion (ANTICIPATED)

March 1, 2019

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (ESTIMATE)

September 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 5, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2015/443-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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