Percutaneous posterior tibial nerve stimulation (PTNS) and biofeedback for treating faecal incontinence

Not Applicable

Completed

• Conditions: Faecal Incontinence; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616000056493
• Lead Sponsor: orthern Sydney Local Health District

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-20
• Study Completion: 2018-12-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

Patients who are referred to biofeedback treatment for faecal incontinence and satisfy the following will be offered participation:
1.Females
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
5.Previous anorectal biofeedback training.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome for assessing feasability will be the completion rate of the program, as defined by at least 80% attendance of treatment sessions and attending the end of treatment assessment by a physician. <br>[3 and 6 months from start of treatment];Primary outcome measure for assessing the impact of PTNS treatment on anorectal physiology will be the change in anorectal manometry (ARM) measurements before and after PTNS treatment. <br>[Anorectal manometry (ARM) will be performed on the screening visit, at visits at 2,5 and 9 weeks, and on the final visit week 13. On each of the visits, ARM will be performed before and after PTNS treatment. ];To assess the efficacy of combination therapy of PTNS and BF for FI. This will be primarly assessed by the reduction in severity of faecal incontinence (FISI and stool diaries).<br>[3 and 6 months from start of treatment]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures for assessing treatment efficacy will include change in quality of life (as assessed by SF36 and VAS for impact of bowel dysfunction on quality of life, control over bowel motions and satisfaction with bowel motions). [On visit 1 VAS, SF-36, FISI and Faecal incontinence questionnaires. <br>On visit 6 VAS questionnaire and FISI. <br>On the final study visit VAS questionnaire, FISI and SF-36 questionnaire will be filled out again. <br>]