Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
1 other identifier
interventional
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 13, 2010
CompletedFirst Posted
Study publicly available on registry
July 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 19, 2018
September 1, 2018
7.8 years
July 13, 2010
September 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
6 weeks
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
12 weeks
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
32 weeks
Secondary Outcomes (6)
Fecal Incontinence
before treatment, 6, 12, 32 wks after initial treatment
Anorectal manometric measurements
12 weeks
Quality of Life
before treatment, 6, 32 wks after initial treatment
Cost
at the end of the treatment
Adverse Events
for each treatment interval
- +1 more secondary outcomes
Study Arms (1)
pTNS treatment
EXPERIMENTALInterventions
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).
Eligibility Criteria
You may qualify if:
- fecal urge incontinence
- conservative treatment has been performed without success
You may not qualify if:
- current anticoagulation treatment
- sphincter defects larger than 120°
- pregnancy
- pace maker
- implanted defibrillators
- severe heart disease
- existing neurological damages
- disposition for strong bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, 9007, Switzerland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lukas T Marti, Dr. med.
Department of Surgery, Cantonal Hospital St. Gallen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
July 13, 2010
First Posted
July 14, 2010
Study Start
January 1, 2010
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
September 19, 2018
Record last verified: 2018-09