Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence

This study has been terminated.
(Study was terminated due to low recruitment rates)
Sponsor:
Information provided by (Responsible Party):
Liliana Bordeianou, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01274585
First received: January 7, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel diary after treatment.

The investigators secondary endpoints will consist of measurements of the impact of PTNS on the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity Index (FISI) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL) scale).


Condition Intervention
Fecal Incontinence
Device: Posterior tibial nerve stimulation (PTNS)
Device: Posterior tibial nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Frequency of Fecal Incontinence [ Time Frame: Diary kept for 14 days following treatment ] [ Designated as safety issue: No ]
    Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.


Secondary Outcome Measures:
  • Change in Fecal Incontinence Severity Index (FISI) Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change in Fecal Incontinence Quality of Life (FIQoL) Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: No active treatment Device: Posterior tibial nerve stimulation
Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
Experimental: stimulation/treatment Device: Posterior tibial nerve stimulation (PTNS)
Stimulation using PTNS device for 30 minutes weekly for 12 weeks
Other Name: Urgent PC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years or older
  • Able to provide informed consent
  • Has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool)
  • Available to present for weekly treatments
  • Available for follow-up at 3, 6, and 12 months

Exclusion Criteria:

  1. Severe cardiopulmonary disease
  2. Lesion of the Tibial Nerve
  3. Use of a cardiac pacemaker or implantable defibrillator
  4. History of inflammatory bowel disease
  5. Active anal fissure, fistula, or abscess
  6. Active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy
  7. Has a sphincter injury that needs sphincteroplasty
  8. Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter
  9. Severe distal venous insufficiency
  10. Uncontrolled diabetes with peripheral nerve involvement
  11. Immunosuppression
  12. Pregnant or planning on becoming pregnant during treatment
  13. Patients prone to 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: NCT01274585

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Liliana Bordeianou, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Liliana Bordeianou, Colorectal Surgeon, PI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01274585     History of Changes
Other Study ID Numbers: MGH2010-P-000239
Study First Received: January 7, 2011
Results First Received: December 30, 2013
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014