Pelvipower for Faecal Incontinence

Summary

Faecal incontinence (FI) is a common condition which drastically reduces patient's quality of life and for which there are few effective treatments. The causes of FI are multiple and include disturbances in neuromuscular function (and structure) of the anal canal, rectum and pelvic floor. Treatment options include antidiarrheals, laxatives, biofeedback, surgery, SNS and PTNS. This study will test the Pelvipower extracorporeal magnetic stimulation device as a treatment for faecal incontinence.

Conditions

• Faecal Incontinence

Interventions

DIAGNOSTIC_TEST

High Resolution Anorectal Manometry

A test used to measure the strength of the muscles in the anal canal

DIAGNOSTIC_TEST

Endoanal Ultrasound

An examination of the anal canal (back passage) that allows us to see the muscles involved in passing stool and the tissues that surround these.

OTHER

Bowel diary

A daily diary to assess episodes of faecal incontinence

OTHER

MYMOP2

Questionnaire to assess individual symptoms, general wellbeing and activity in faecal incontinence

OTHER

FIQOL

Questionnaire to assess the quality of life with faecal incontinence

OTHER

FISI

Questionnaire to assess the severity of faecal incontinence

OTHER

Follow up call

At 28 days and 3 months post final pelvipower or sham session to assess faecal incontience after study period

OTHER

St Mark's incontinence score

A score of incontinence

Sponsors & Collaborators

• The Functional Gut Clinic

  lead OTHER

Principal Investigators

• Anthony Hobson · The Functional Gut Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2023-12-01

Completion

2024-04-01

Countries

• United Kingdom

Study Locations