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Completed

NCT Number: NCT01162525

Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous tibial nerve stimulation (pTNS)

Procedure

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

Primary outcomes

  1. Fecal Incontinence

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Fecal Incontinence

    Time frame: 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

    Time frame: 12 weeks

    compared to pre-treatment values

  3. Quality of Life

    Time frame: 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

    Time frame: at the end of the treatment

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

  5. Adverse Events

    Time frame: 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

    Time frame: before treatment, 6, 12, 32 wks after initial treatment

    Hanley Score (BMJ (2001) 322:1096)

    • Urinary incontinence score

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2010
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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