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Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Percutaneous tibial nerve stimulation (pTNS)
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Fecal Incontinence, Fecal Urge Incontinence, Percutaneous tibial nerve stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, Cantonal Hospital St. Gallen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pTNS treatment

Arm Description

Outcomes

Primary Outcome Measures

Fecal Incontinence
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
Fecal Incontinence
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
Fecal Incontinence
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

Secondary Outcome Measures

Fecal Incontinence
Vaizey Score (Gut (1999) 44:77) Fecal incontinence score similar to Wexner Score
Anorectal manometric measurements
compared to pre-treatment values
Quality of Life
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
Cost
total cost of treatment will be evaluated (material, work hours etc)
Adverse Events
adverse events between treatments: pain, bleeding, neurological sensation, other AE Adverse events during percutaneous nerve stimulation: pain, bleeding and discomfort
Urinary incontinence
Hanley Score (BMJ (2001) 322:1096) Urinary incontinence score

Full Information

First Posted
July 13, 2010
Last Updated
September 18, 2018
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT01162525
Brief Title
Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
Official Title
Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
Fecal Incontinence, Fecal Urge Incontinence, Percutaneous tibial nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pTNS treatment
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Percutaneous tibial nerve stimulation (pTNS)
Other Intervention Name(s)
pTNS, peripheral tibial nerve stimulation, peripheral neuromodulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Fecal Incontinence
Description
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
Time Frame
6 weeks
Title
Fecal Incontinence
Description
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
Time Frame
12 weeks
Title
Fecal Incontinence
Description
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
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Fecal Incontinence
Description
Vaizey Score (Gut (1999) 44:77) Fecal incontinence score similar to Wexner Score
Time Frame
before treatment, 6, 12, 32 wks after initial treatment
Title
Anorectal manometric measurements
Description
compared to pre-treatment values
Time Frame
12 weeks
Title
Quality of Life
Description
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
Time Frame
before treatment, 6, 32 wks after initial treatment
Title
Cost
Description
total cost of treatment will be evaluated (material, work hours etc)
Time Frame
at the end of the treatment
Title
Adverse Events
Description
adverse events between treatments: pain, bleeding, neurological sensation, other AE Adverse events during percutaneous nerve stimulation: pain, bleeding and discomfort
Time Frame
for each treatment interval
Title
Urinary incontinence
Description
Hanley Score (BMJ (2001) 322:1096) Urinary incontinence score
Time Frame
before treatment, 6, 12, 32 wks after initial treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukas T Marti, Dr. med.
Organizational Affiliation
Department of Surgery, Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Cantonal Hospital St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.chirurgie.kssg.ch/home/unsere_klinik.html
Description
Website of the Department of Surgery, Cantonal Hospital of St. Gallen (German only)

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Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

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