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
  Purpose

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 Intervention
Fecal Incontinence
Procedure: Percutaneous tibial nerve stimulation (pTNS)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Tibial Nerve Stimulation (pTNS) for Patients With Fecal Urge Incontinence

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162525

Contacts
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

Locations
Switzerland
Department of Surgery, Cantonal Hospital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Christine Maurus, Dr. med    +41 71 494 1111    christine.Maurus@kssg.ch   
Sub-Investigator: Christine Maurus, Dr. med.         
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Lukas T Marti, Dr. med. Department of Surgery, Cantonal Hospital St. Gallen
  More Information

Additional Information:
No publications provided

Responsible Party: Lukas Marti, Attending physician, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01162525     History of Changes
Other Study ID Numbers: pTNS
Study First Received: July 13, 2010
Last Updated: August 4, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:
Fecal Incontinence
Fecal Urge Incontinence
Percutaneous tibial nerve stimulation

Additional relevant MeSH terms:
Fecal Incontinence
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 30, 2014