Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
NCT ID: NCT01162525
Last Updated: 2018-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2010-01-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pTNS treatment
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* conservative treatment has been performed without success
Exclusion Criteria
* sphincter defects larger than 120°
* pregnancy
* pace maker
* implanted defibrillators
* severe heart disease
* existing neurological damages
* disposition for strong bleeding
18 Years
80 Years
ALL
No
Sponsors
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Cantonal Hospital of St. Gallen
OTHER
Responsible Party
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Lukas Marti
Attending physician
Principal Investigators
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Lukas T Marti, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Cantonal Hospital St. Gallen
Locations
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Department of Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, , Switzerland
Countries
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Related Links
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Website of the Department of Surgery, Cantonal Hospital of St. Gallen (German only)
Other Identifiers
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pTNS
Identifier Type: -
Identifier Source: org_study_id
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