Pelvipower for Faecal Incontinence

NCT05900726 | Unknown

• 1 other identifier: FGC-20-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Bowel diary - total FI episodes

  Assessment of change in total faecal incontinence episodes as measured as a reduction by \>= 50%

  up to 10 weeks

Secondary Outcomes (7)

• Bowel diary - passive FI episodes

  up to 10 weeks

• Bowel diary - urgency FI Episodes

  up to 10 weeks

• St Mark's incontinence score

  up to 5 months

• Loperamide use

  up to 10 weeks

• Measure Yourself Medical Outcome Profile 2 (MYMOP2)

  up to 5 months

Other Outcomes (4)

• Assessment of anal canal resting tone

  up to 10 weeks

• Assessment of voluntary anal squeeze pressures

  up to 10 weeks

• Assessment of rectal sensation

  up to 10 weeks

Study Arms (2)

Pelvipower chair

EXPERIMENTAL

Diagnostic Test: High Resolution Anorectal Manometry; Diagnostic Test: Endoanal Ultrasound; Other: Bowel diary; Other: MYMOP2; Other: FIQOL; Other: FISI; Other: Follow up call; Other: St Mark's incontinence score

Sham stimulation

SHAM COMPARATOR

Diagnostic Test: High Resolution Anorectal Manometry; Diagnostic Test: Endoanal Ultrasound; Other: Bowel diary; Other: MYMOP2; Other: FIQOL; Other: FISI; Other: Follow up call; Other: St Mark's incontinence score

Interventions

High Resolution Anorectal Manometry DIAGNOSTIC_TEST

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

Pelvipower chair; Sham stimulation

Endoanal Ultrasound DIAGNOSTIC_TEST

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.

Pelvipower chair; Sham stimulation

Bowel diary OTHER

A daily diary to assess episodes of faecal incontinence

Pelvipower chair; Sham stimulation

MYMOP2 OTHER

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

Pelvipower chair; Sham stimulation

FIQOL OTHER

Questionnaire to assess the quality of life with faecal incontinence

Pelvipower chair; Sham stimulation

FISI OTHER

Questionnaire to assess the severity of faecal incontinence

Pelvipower chair; Sham stimulation

Follow up call OTHER

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

Pelvipower chair; Sham stimulation

St Mark's incontinence score OTHER

A score of incontinence

Pelvipower chair; Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Female
• Have suffered from faecal incontinence, for \>6 months, sufficiently severe enough to warrant intervention . Previous exposure to treatment is not a contraindication to this.
• Body Mass Index between 18.9 and 40.0kg/m2 (bounds included)
• \>6 months post-natal
• ≥4 FI episodes during 2 week screening period

You may not qualify if:

• Neurological disease which may affect continence (i.e. diabetic neuropathy, multiple sclerosis, Parkinson's disease etc)
• Thromboses
• Suffering from or recovering from a serious illness or operation
• Faecal incontinence secondary to impaction
• Currently using rectal irrigation
• Currently undergoing biofeedback therapy
• Pregnancy
• Pacemaker in situ
• Indwelling metal implants
• Recent skeletomuscular injury or surgery in the last month
• Congenital anorectal disorders such as cloacal defect
• Participant has a \> grade 2 rectal prolapse
• Absence of native rectum due to surgery (anterior resection)
• Previous anal/rectal surgery in the past 12 months
• Stoma in situ

Sponsors & Collaborators

• The Functional Gut Clinic: lead

Study Sites (1)

The Functional Gut Clinic

London, NW1 6PU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Anthony Hobson

  The Functional Gut Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam Treadway

CONTACT

0161 302 7777; sam.treadway@thefunctionalgutclinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomised allocation to treatment or sham arm will be performed using sealedenvelope.com, the software will only be available to the study team. Participant ID's will be entered 001 - 036 randomisation tool on sealedenvelope.com where they will be assigned to group A (treatment) or group B (sham). A randomisation log will be kept in the site file. Participants will be blinded to which group they have been assigned too.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Model Details: This protocol describes a single blinded, two-armed, parallel-group, randomised exploratory study with control arm, assessing the effect of pelvic floor magnetic neuromuscular stimulation (Pelvipower) versus sham stimulation, in patients with faecal incontinence.

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: June 13, 2023
• Study Start: March 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

GB (1)