NCT01274585

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
5 months until next milestone

Results Posted

Study results publicly available

February 13, 2014

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

January 7, 2011

Results QC Date

December 30, 2013

Last Update Submit

December 5, 2017

Conditions

Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Frequency of Fecal Incontinence

    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.

    Diary kept for 14 days following treatment

Secondary Outcomes (2)

  • Change in Fecal Incontinence Severity Index (FISI) Score

    12 weeks

  • Change in Fecal Incontinence Quality of Life (FIQoL) Score

    12 weeks

Study Arms (2)

No active treatment

SHAM COMPARATOR
Device: Posterior tibial nerve stimulation

stimulation/treatment

EXPERIMENTAL
Device: Posterior tibial nerve stimulation (PTNS)

Interventions

Posterior tibial nerve stimulation (PTNS)DEVICE

Stimulation using PTNS device for 30 minutes weekly for 12 weeks

Also known as: Urgent PC
stimulation/treatment
Posterior tibial nerve stimulationDEVICE

Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks

No active treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients
Organization
Massachusetts General Hospital
lsavitt@partners.org
617-643-0541

Study Officials

  • Liliana Bordeianou, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Colorectal Surgeon, PI

Study Record Dates

First Submitted

January 7, 2011

First Posted

January 11, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 5, 2018

Results First Posted

February 13, 2014

Record last verified: 2017-12

Locations

US(1)