Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

September 18, 2018 updated by: Lukas Marti, Cantonal Hospital of St. Gallen

Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence

Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal urge continence at the Cantonal Hospital St. Gallen. During this introduction phase efficiency und adverse events will be monitored in this observational study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before treatment patients will have a proctological exam, a proctoscopy, endosonography and anorectal manometry. Incontinence scores (Wexner, Vaizey, Hanley) and quality of life scores (FIQL, VAS) will be recorded.

Treatment consists of 4 phases with decreasing frequency of percutaneous tibial nerve stimulations (pTNS).

During phase 1 weekly stimulations of 30 mins are applied for 12 weeks. After 6 and 12 weeks incontinence scores are recorded. Additionally after the end of phase 1 quality of life is measured and an anorectal manometry is preformed.

Phase 2 lasts for 8 weeks, with 2-3 stimulations/month Phase 3 lasts for 8 weeks, with stimulations every 3 weeks Phase 4 consists of one stimulation in one month.

After phase 4 incontinence scores und quality of life are measured.

Study Type

Interventional

Enrollment (Actual)

57

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

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Department of Surgery, Cantonal Hospital St. Gallen

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fecal urge incontinence
  • conservative treatment has been performed without success

Exclusion Criteria:

  • current anticoagulation treatment
  • sphincter defects larger than 120°
  • pregnancy
  • pace maker
  • implanted defibrillators
  • severe heart disease
  • existing neurological damages
  • disposition for strong bleeding

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pTNS treatment
Procedure: Percutaneous tibial nerve stimulation (pTNS)
A 34 gauge needle in placed close to the tibial nerve about 2-3 cm above the ankle. A self-adhesive surface electrode is placed on the skin. Needle and surface electrode are connected to an electric stimulator and the stimulating current (0 - 10 mA) is increased in 20 steps. When the patient feels a tingling sensation in the foot, stimulating current is set back for one step and the treatment is started (30 min stimulation).
Other Names:
  • pTNS
  • peripheral tibial nerve stimulation
  • peripheral neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal Incontinence
Time Frame: 6 weeks

Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment

  • Score for fecal incontinence, with 5 items and score range of 0 - 20
6 weeks
Fecal Incontinence
Time Frame: 12 weeks

Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment

  • Score for fecal incontinence, with 5 items and score range of 0 - 20
12 weeks
Fecal Incontinence
Time Frame: 32 weeks

Jorge Wexner Score (Dis Colon Rectum (1993) 36:77) compared to pretreatment

  • Score for fecal incontinence, with 5 items and score range of 0 - 20
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal Incontinence
Time Frame: before treatment, 6, 12, 32 wks after initial treatment

Vaizey Score (Gut (1999) 44:77)

  • Fecal incontinence score similar to Wexner Score
before treatment, 6, 12, 32 wks after initial treatment
Anorectal manometric measurements
Time Frame: 12 weeks
compared to pre-treatment values
12 weeks
Quality of Life
Time Frame: before treatment, 6, 32 wks after initial treatment

2 scores for quality of life are measured:

  • Fecal Incontinence Quality of Life (FIQL) (Dis Colon Rectum (2000) 43:9)
  • Visual Analogue Score Patients are asked to score their well-being in respect to the incontinence by marking a horizontal 10 cm line labelled "extremely bad" and "excellent" at both ends
before treatment, 6, 32 wks after initial treatment
Cost
Time Frame: at the end of the treatment
total cost of treatment will be evaluated (material, work hours etc)
at the end of the treatment
Adverse Events
Time Frame: for each treatment interval

adverse events between treatments:

  • pain, bleeding, neurological sensation, other AE

Adverse events during percutaneous nerve stimulation:

  • pain, bleeding and discomfort
for each treatment interval
Urinary incontinence
Time Frame: before treatment, 6, 12, 32 wks after initial treatment

Hanley Score (BMJ (2001) 322:1096)

  • Urinary incontinence score
before treatment, 6, 12, 32 wks after initial treatment

Collaborators and Investigators

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

Sponsor

Cantonal Hospital of St. Gallen

Investigators

  • Principal Investigator: Lukas T Marti, Dr. med., Department of Surgery, Cantonal Hospital St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2010

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 13, 2010

First Posted (Estimate)

July 14, 2010

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 18, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pTNS

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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