Libertas: rationale and study design of a multicentre, <scp>P</scp>hase <scp>II</scp>, double–blind, randomised, placebo–controlled investigation to evaluate the efficacy, safety and tolerability of locally applied <scp>NRL</scp>001 in patients with faecal incontinence

Siproudhis, L.; Jones, D. B.; Shing, Richard Ng Kwet; Walker, David; Scholefield, J H

doi:10.1111/codi.12546

Cited by 8 publications

(2 citation statements)

References 34 publications

(41 reference statements)

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“…Three hundred and fifty‐five papers were eligible for inclusion after the elimination of duplicates and screening of all titles. After careful evaluation of full‐text papers 27 studies were excluded: 15 studies 23–37 did not evaluate FI assessment, six manuscripts 38–43 were just protocols, five were paediatric studies, 44–48 and one trial 49 had an inappropriate study design. Finally, 328 studies were included in our review: 306 studies…”

Section: Resultsmentioning

confidence: 99%

Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review

et al. 2020

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Background Fecal incontinence is a disabling condition affecting up to 20% of women. Objective We investigated fecal incontinence assessment in both inflammatory bowel disease and non-inflammatory bowel disease patients to propose a diagnostic approach for inflammatory bowel disease trials. Methods We searched on Pubmed, Embase and Cochrane Library for all studies on adult inflammatory bowel disease and non-inflammatory bowel disease patients reporting data on fecal incontinence assessment from January 2009 to December 2019. Results In total, 328 studies were included; 306 studies enrolled non-inflammatory bowel disease patients and 22 studies enrolled inflammatory bowel disease patients. In non-inflammatory bowel disease trials the most used tools were the Wexner score, fecal incontinence quality of life questionnaire, Vaizey score and fecal incontinence severity index (in 187, 91, 62 and 33 studies). Anal manometry was adopted in 41.2% and endoanal ultrasonography in 34.0% of the studies. In 142 studies (46.4%) fecal incontinence evaluation was performed with a single instrument, while in 64 (20.9%) and 100 (32.7%) studies two or more instruments were used. In inflammatory bowel disease studies the Wexner score, Vaizey score and inflammatory bowel disease quality of life questionnaire were the most commonly adopted tools (in five (22.7%), five (22.7%) and four (18.2%) studies). Anal manometry and endoanal ultrasonography were performed in 45.4% and 18.2% of the studies. Conclusion Based on prior validation and experience, we propose to use the Wexner score as the first step for fecal incontinence assessment in inflammatory bowel disease trials. Anal manometry and/or endoanal ultrasonography should be taken into account in the case of positive questionnaires.

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Section: Resultsmentioning

confidence: 99%

Tools for fecal incontinence assessment: lessons for inflammatory bowel disease trials based on a systematic review

et al. 2020

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“…NRL001 is undertaking its journey through this complex process and this supplement describes the early Phase I work together with a meta‐analysis of the cardiovascular data from these studies; see Table for a list of the studies reported . In addition, the Phase II clinical study design is presented .…”

Section: Studies Reported In This Supplementmentioning

confidence: 99%