PROMs for FI in SSc
Research type
Research Study
Full title
Validity and Performance of Patient-Reported Outcome Measures for Fecal Incontinence in Systemic Sclerosis (PROM-FISSc)
IRAS ID
368326
Contact name
Michael Hughes
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
P015905, Prime Award Number; SA0005308, Subaward Number (UoM); NHS002327, Study Reference (UoM)
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Systemic sclerosis (also known as scleroderma) is an autoimmune condition that can commonly affect the gastrointestinal (digestive) system. One distressing but under-recognised problem is faecal incontinence, meaning accidental leakage of stool. This can have a major impact on daily life, work, and mental wellbeing. Despite this, faecal incontinence in systemic sclerosis has received little research attention.
Several questionnaires already exist to measure the severity and impact of faecal incontinence. These are known as patient-reported outcome measures (PROMs), meaning tools that ask patients directly about their symptoms and quality of life. However, these questionnaires have not been properly tested in people with systemic sclerosis. We do not yet know which are the most reliable or accurate in this condition.
This study aims to assess how well existing faecal incontinence questionnaires perform in adults with systemic sclerosis. We will compare questionnaire scores with a 7-day bowel diary, which records episodes of incontinence.
Participants will be adults with systemic sclerosis who have experienced faecal incontinence in the previous week.
The study will take place in specialist rheumatology centres in the United Kingdom and the United States.
Participants will complete questionnaires and a 7-day bowel diary at the start of the study and again one week later.
A small subgroup will repeat these measures after three months if their usual treatment for bowel symptoms is changed by their medical team. No experimental treatments are involved.
The study is funded by the Scleroderma Clinical Trials Consortium.
By identifying the most accurate and practical questionnaires, this research will improve how faecal incontinence is measured in clinical practice and future research, helping to support better care and treatment development.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
26/YH/0127
Date of REC Opinion
12 Jun 2026
REC opinion
Favourable Opinion