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

NCT ID: NCT01274585

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-10-31

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).

Conditions

Fecal Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

No active treatment

Group Type: SHAM_COMPARATOR

Posterior tibial nerve stimulation

Intervention Type: DEVICE

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

stimulation/treatment

Group Type: EXPERIMENTAL

Posterior tibial nerve stimulation (PTNS)

Intervention Type: DEVICE

Stimulation using PTNS device for 30 minutes weekly for 12 weeks

Interventions

Posterior tibial nerve stimulation (PTNS)

Stimulation using PTNS device for 30 minutes weekly for 12 weeks

Intervention Type: DEVICE

Posterior tibial nerve stimulation

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

Intervention Type: DEVICE

Other Intervention Names

Urgent PC

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liliana Bordeianou

Colorectal Surgeon, PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liliana Bordeianou, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

MGH2010-P-000239

Identifier Type: -

Identifier Source: org_study_id