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Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

Sponsor
Cantonal Hospital of St. Gallen (Other)
Overall Status
Completed
CT.gov ID
NCT01162525
Collaborator
(none)
57
Enrollment
1
Location
1
Arm
95
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous tibial nerve stimulation (pTNS)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Fecal Incontinence [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

    2. Fecal Incontinence [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

    3. Fecal Incontinence [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

    Secondary Outcome Measures

    1. Fecal Incontinence [before treatment, 6, 12, 32 wks after initial treatment]

      Vaizey Score (Gut (1999) 44:77) Fecal incontinence score similar to Wexner Score

    2. Anorectal manometric measurements [12 weeks]

      compared to pre-treatment values

    3. Quality of Life [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

    4. Cost [at the end of the treatment]

      total cost of treatment will be evaluated (material, work hours etc)

    5. Adverse Events [for each treatment interval]

      adverse events between treatments: pain, bleeding, neurological sensation, other AE Adverse events during percutaneous nerve stimulation: pain, bleeding and discomfort

    6. Urinary incontinence [before treatment, 6, 12, 32 wks after initial treatment]

      Hanley Score (BMJ (2001) 322:1096) Urinary incontinence score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Surgery, Cantonal Hospital St. Gallen St. Gallen Switzerland 9007

    Sponsors and Collaborators

    • Cantonal Hospital of St. Gallen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Lukas Marti, Attending physician, Cantonal Hospital of St. Gallen
    ClinicalTrials.gov Identifier:
    NCT01162525
    Other Study ID Numbers:
    • pTNS
    First Posted:
    Jul 14, 2010
    Last Update Posted:
    Sep 19, 2018
    Last Verified:
    Sep 1, 2018
    Keywords provided by Lukas Marti, Attending physician, Cantonal Hospital of St. Gallen
    Fecal Incontinence
    Fecal Urge Incontinence
    Percutaneous tibial nerve stimulation
    Additional relevant MeSH terms:
    Fecal Incontinence

    Study Results

    No Results Posted as of Sep 19, 2018