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
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
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
NCT ID
NCT01162525
First Posted
July 13, 2010
Last Updated
September 18, 2018
Sponsor
Cantonal Hospital of St. Gallen
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)
Learn more about this trial
Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
We'll reach out to this number within 24 hrs