Trial reportNeurogastroenterology and motility2016
Validating endpoints for therapeutic trials in fecal incontinence.
Trial report in Neurogastroenterology and motility, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03489265 (Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline), which is not on this map. Cited by 17 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline
Who cites it
17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- Global Prevalence of Fecal Incontinence in Community-Dwelling Adults: A Systematic Review and Meta-analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024Pooled it
- Tibial nerve electrical stimulation for fecal incontinence: a systematic review and meta-analysis.Updates in surgery · 2023Pooled it
- A systematic review of English language patient-reported outcome measures for use in urogynaecology and female pelvic medicine.International urogynecology journal · 2021Pooled it
- Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review.United European gastroenterology journal · 2020Pooled it
- Correlation Between Mobile-Application Electronic Bowel Diary and Validated Questionnaires in Women with Fecal Incontinence.International urogynecology journal · 2024Trial
- A randomized double-blind trial of clonidine and colesevelam for women with fecal incontinence.Neurogastroenterology and motility · 2024Trial
- Characteristics Associated With Clinically Important Treatment Responses in Women Undergoing Nonsurgical Therapy for Fecal Incontinence.The American journal of gastroenterology · 2020Trial
- Development and Validation of a Bowel Diary for Fecal Incontinence: Comparison With a Questionnaire.Neurogastroenterology and motility · 2025Article
- Automated extraction of anorectal pressures from high-resolution manometry reports.Neurogastroenterology and motility · 2022Article
- Optimizing techniques for measuring anal resting and squeeze pressures with high-resolution manometry.Neurogastroenterology and motility · 2022Article
- Faecal incontinence in adults.Nature reviews. Disease primers · 2022Review
- Translumbosacral Neuromodulation Therapy Is a Promising Option for Fecal Incontinence.The American journal of gastroenterology · 2021Article
- Clinical Evaluation of a Patient With Symptoms of Colonic or Anorectal Motility Disorders.Journal of neurogastroenterology and motility · 2020Review
- Cortico-anorectal, Spino-anorectal, and Cortico-spinal Nerve Conduction and Locus of Neuronal Injury in Patients With Fecal Incontinence.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2019Article
- Relationship between symptoms and quality of life in fecal incontinence.Neurogastroenterology and motility · 2018Article
- Surgical Interventions and the Use of Device-Aided Therapy for the Treatment of Fecal Incontinence and Defecatory Disorders.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2017Review
- Endpoints for therapeutic interventions in faecal incontinence: small step or game changer.Neurogastroenterology and motility · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundA 50% or greater reduction in the frequency of fecal incontinence (FI) recorded with daily bowel diaries is the primary endpoint in clinical trials of FI. Whether this difference is clinically important is unknown. The relationship between FI symptoms recorded with daily and weekly instruments is unknown. The contribution of psychological factors to quality of life (QOL) in FI is unclear.
methodsFecal incontinence severity was assessed with daily bowel diaries and periodic questionnaires (fecal incontinence severity score [FISS], FIQOL, 36-Item Short Form Health Survey [SF-36], and hospital anxiety and depression scales) for 4 weeks before and during double-blind randomization to placebo or clonidine in 44 women with FI. The reduction in FI frequency was compared to the minimal clinically important difference (MCID) computed from the FISS. Endpoints of FI were compared between daily and weekly diaries. KEY
resultsThe FISS exceeded the MCID in 75% and 83% of patients in whom the FI frequency declined by 50-74% and ≥75% respectively. Parameters of FI measured with daily and weekly instruments were significantly correlated. The daily parameters explained 71% of the inter-patient variation in the FISS. The SF-36 health scores, rather than the FISS rating, explained a majority of the inter-subject variation in FIQOL. CONCLUSIONS & INFERENCES: Most patients who report a ≥50% reduction in FI frequency experience a clinically important improvement. Weekly questionnaires accurately assess the severity of FI. Self-reported physical and mental health explained a greater proportion of the variance in FIQOL than FI symptom severity.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.