Percutaneous posterior tibial nerve stimulation (PTNS) for treating faecal incontinence in females: A pilot study of combination treatment with biofeedback.

orthern Sydney Local Health District0 sites13 target enrollmentJanuary 20, 2016

ConditionsFaecal Incontinence Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Overview

Phase: 未知
Intervention: Not specified
Conditions: Faecal Incontinence
Sponsor: orthern Sydney Local Health District
Enrollment: 13
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study shows that combining PTNS with biofeedback for the treatment of faecal incontinence in women is feasible, safe and well accepted by both patients and nurses. As this was a pilot study, conclusions regarding efficacy await larger studies.

Registry

who.int

Start Date

January 20, 2016

End Date

December 1, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

Female

Investigators

Sponsor

orthern Sydney Local Health District

Eligibility Criteria

Inclusion Criteria

•Patients who are referred to biofeedback treatment for faecal incontinence and satisfy the following will be offered participation:
•2\.Age \>\=18 and \=\<80
•3\. Faecal incontinence: defined as an uncontrolled passage of faecal material occurring at least 2\-4 times a month, in the last 6 months.
•4\.Urge symptoms: defined as having an urge sensation before the uncontrolled passage in at least part of the FI episodes.
•5\.Failure of a trial of diet and bulking or laxative therapy in an effort to restore normal bowel movements.
•6\.Severity of FI: a minimal score of 8 on the FIS.
•7\.Willingness to give written informed consent and willingness to comply with the study.

Exclusion Criteria

•1\.Presence of overt organic anorectal disorder \- based on standard testing including physician assessment and imaging (anorectal ultrasound and/or colonoscopy).
•2\.Any general medical condition or medication that may compromise PTNS/BF treatment including:
•a.Hypercoagulability state or anti\-coagulation medication.
•b.Latex allergy.
•c.Implanted stimulator, pacemaker or defibrillator
•d.Sciatica symptoms
•e.Peripheral neuropathy
•f.Peripheral vascular disease
•3\.Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.
•4\.Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study