Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Cantonal Hospital of St. Gallen
Sponsor:
Information provided by (Responsible Party):
Lukas Marti, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01162525
First received: July 13, 2010
Last updated: August 4, 2014
Last verified: August 2014

July 13, 2010
August 4, 2014
January 2010
March 2017   (final data collection date for primary outcome measure)
  • Fecal Incontinence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

    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
Same as current
Complete list of historical versions of study NCT01162525 on ClinicalTrials.gov Archive Site
  • Fecal Incontinence [ Time Frame: before treatment, 6, 12, 32 wks after initial treatment ] [ Designated as safety issue: No ]

    Vaizey Score (Gut (1999) 44:77)

    • Fecal incontinence score similar to Wexner Score
  • Anorectal manometric measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    compared to pre-treatment values
  • Quality of Life [ Time Frame: before treatment, 6, 32 wks after initial treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: at the end of the treatment ] [ Designated as safety issue: No ]
    total cost of treatment will be evaluated (material, work hours etc)
  • Adverse Events [ Time Frame: for each treatment interval ] [ Designated as safety issue: Yes ]

    adverse events between treatments:

    • pain, bleeding, neurological sensation, other AE

    Adverse events during percutaneous nerve stimulation:

    • pain, bleeding and discomfort
  • Urinary incontinence [ Time Frame: before treatment, 6, 12, 32 wks after initial treatment ] [ Designated as safety issue: No ]

    Hanley Score (BMJ (2001) 322:1096)

    • Urinary incontinence score
  • Fecal Incontinence [ Time Frame: before treatment, 6, 12, 32 wks after initial treatment ] [ Designated as safety issue: No ]

    Vaizey Score (Gut (1999) 44:77)

    • Fecal incontinence score similar to Wexner Score
  • Anorectal manometric measurements [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    compared to pre-treatment values
  • Quality of Life [ Time Frame: before treatment, 6, 32 wks after initial treatment ] [ Designated as safety issue: No ]

    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 "extremly bad" and "excellent" at both ends
  • Cost [ Time Frame: at the end of the treatment ] [ Designated as safety issue: No ]
    total cost of treatment will be evaluated (material, work hours etc)
  • Adverse Events [ Time Frame: for each treatment interval ] [ Designated as safety issue: Yes ]

    adverse events between treatments:

    • pain, bleeding, neurological sensation, other AE

    Adverse events during percutaneous nerve stimulation:

    • pain, bleeding and discomfort
  • Urinary incontinence [ Time Frame: before treatment, 6, 12, 32 wks after initial treatment ] [ Designated as safety issue: No ]

    Hanley Score (BMJ (2001) 322:1096)

    • Urinary incontinence score
Not Provided
Not Provided
 
Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence
Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge 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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fecal Incontinence
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
Experimental: pTNS treatment
Intervention: Procedure: Percutaneous tibial nerve stimulation (pTNS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2017
March 2017   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Christine Maurus, Dr. med. +41 71 494 1111 christine.maurus@kssg.ch
Contact: Ulrich Beutner, Ph.D. +41 71 494 1111 ulrich.beutner@kssg.ch
Switzerland
 
NCT01162525
pTNS
No
Lukas Marti, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
Not Provided
Principal Investigator: Lukas T Marti, Dr. med. Department of Surgery, Cantonal Hospital St. Gallen
Cantonal Hospital of St. Gallen
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP