Abstract
Introduction and Hypothesis
Despite growing interest in a mobile-app bowel diary to assess fecal incontinence (FI) symptoms, data are limited regarding the correlation between mobile-app diary and questionnaire-based outcomes. The primary aim is to determine whether percentage reduction in FI episodes (FIEs)/week recorded on a mobile-app diary correlates with changes in scores of validated FI-symptom measures from baseline to 12 weeks in women with FI undergoing percutaneous tibial nerve stimulation (PTNS) versus sham.
Methods
This is a planned secondary analysis of a multicenter randomized trial in which women with FI underwent PTNS or sham. FIEs were collected using a mobile-app diary at baseline and after 12 weekly sessions. FI-symptom-validated measures included St. Mark’s, Accidental Bowel Leakage Evaluation, FI Severity Index (FISI), Colorectal Anal Distress Inventory, Colorectal Anal Impact Questionnaire, FI Quality of Life, Patient Global Impression of Improvement (PGI-I), and Patient Global Symptom Control (PGSC) rating. Spearman’s correlation coefficient (ρ) was computed between %-reduction in FIEs/week and change in questionnaire scores from baseline to 12 weeks. Significance was set at 0.005 to account for multiple comparisons.
Results
Baseline characteristics of 163 women (109 PTNS, 54 sham) include mean age 63.4±11.6, 81% white, body mass index 29.4±6.6 kg/m2, 4% previous FI surgeries, 6.6±5.5 FIEs/week, and St. Mark’s score 17.4±2.6. A significant correlation was demonstrated between %-reduction in FIEs/week and all questionnaires (p<0.005). A moderate-strength correlation (|ρ|>0.4) was observed for St. Mark’s (ρ=0.48), FISI (ρ=0.46), PGI-I (ρ=0.51), and PGSC (ρ=−0.43).
Conclusions
In women with FI randomized to PTNS versus sham, a moderate correlation was noted between FIEs measured via mobile-app diary and FI-symptom-validated questionnaire scores.
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References
Menees SB, Almario CV, Spiegel BMR, Chey WD. Prevalence of and factors associated with fecal incontinence: results from a population-based survey. Gastroenterology. 2018;154:1672–1681.e3.
Melville JL, Fan MY, Newton K, Fenner D. Fecal incontinence in US women: a population-based study. Am J Obstet Gynecol. 2005;193:2071–6.
Brown HW, Wexner SD, Segall MM, Brezoczky KL, Lukacz ES. Accidental bowel leakage in the mature women’s health study: prevalence and predictors. Int J Clin Pract. 2012;66:1101–8.
Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient compliance with paper and electronic diaries. Control Clin Trials. 2003;24:182–99.
Mateu Arrom L, Peri Cusi L, López-Fando L, Franco de Castro A, Jiménez Cidre MÁ, Alcaraz A. Validation of a 3 day electronic bladder diary as an app for smart-phone. Neurourol Urodyn. 2019;38:764–9.
Quinn P, Goka J, Richardson H. Assessment of an electronic daily diary in patients with overactive bladder. BJU Int. 2003;91:647–52.
Abrams P, Paty J, Martina R, et al. Electronic bladder diaries of differing duration versus a paper diary for data collection in overactive bladder. Neurourol Urodyn. 2016;35:743–9.
Zyczynski HM, Richter HE, Sung VW, et al. Percutaneous tibial nerve stimulation vs sham stimulation for fecal incontinence in women: NeurOmodulaTion for Accidental Bowel Leakage randomized clinical trial. Am J Gastroenterol. 2022;117:654–67.
Zyczynski HM, Richter HE, Sung VW, et al. Performance, acceptability, and validation of a phone application bowel diary. Neurourol Urodyn. 2020;39:2480–9.
Zyczynski HM, Arya LA, Lukacz ES, et al. Design of a randomized controlled trial of percutaneous posterior tibial nerve stimulation for the treatment of refractory fecal incontinence in women: the NeurOmodulaTion for Accidental Bowel Leakage Study. Female Pelvic Med Reconstr Surg. 2021;27:726–34.
Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut. 1999;44:77–80.
Bols EMJ, Hendriks EJM, Deutekom M, Berghmans BCM, CGMI Baeten, de Bie RA. Inconclusive psychometric properties of the Vaizey score in fecally incontinent patients: a prospective cohort study. Neurourol Urodyn. 2010;29:370–7.
Rogers RG, Sung VW, Lukacz ES, et al. Accidental bowel leakage evaluation: a new patient-centered validated measure of accidental bowel leakage symptoms in women. Dis Colon Rectum. 2020;63:668–77.
Rogers RG, Sung VW, Lukacz ES, et al. The responsiveness and minimally important difference for the Accidental Bowel Leakage Evaluation questionnaire. Int Urogynecol J. 2020;31:2499–505.
Rockwood TH, Church JM, Fleshman JW, et al. Patient and surgeon ranking of the severity of symptoms associated with fecal incontinence: the Fecal Incontinence Severity Index. Dis Colon Rectum. 1999;42:1525–32.
Jelovsek JE, Chen Z, Markland AD, et al. Minimum important differences for scales assessing symptom severity and quality of life in patients with fecal incontinence. Female Pelvic Med Reconstr Surg. 2014;20:342–8.
Noelting J, Zinsmeister AR, Bharucha AE. Validating endpoints for therapeutic trials in fecal incontinence. Neurogastroenterol Motil. 2016;28:1148–56.
Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003;189:98–101.
Atkinson MJ, Sinha A, Hass SL, et al. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004;2:12.
Rao SSC. Endpoints for therapeutic interventions in fecal incontinence: small step or game changer. Neurogastroenterol Motil. 2016;28:1123.
Wexner SD, Coller JA, Devroede G, et al. Sacral nerve stimulation for fecal incontinence: results of a 120-patient prospective multicenter study. Ann Surg. 2010;251:441–9.
Asnong A, D’hoore A, Wolthuis A, Van Molhem Y. Is evaluation by questionnaires sufficient to cover all aspects of bowel symptoms in rectal cancer patients after low anterior resection? Colorectal Dis. 2022;24(5):611–20. https://doi.org/10.1111/codi.16055.
Landefeld CS, Bowers BJ, Feld AD, et al. National Institutes of Health state-of-the-science conference statement: prevention of fecal and urinary incontinence in adults. Ann Intern Med. 2008;148:449–58.
Bharucha AE, Fletcher JG, Camilleri M, et al. Effects of clonidine in women with fecal incontinence. Clin Gastroenterol Hepatol. 2014;12:843–51.e2; quiz e44.
Acknowledgements
In addition to the authors, the following members of the Pelvic Floor Disorders Network participated in the index study, Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial (NOTABLe): Alpert Medical School of Brown University, Providence, RI, USA—Cassandra Carberry, B. Star Hampton, Nicole Korbly, Ann Schantz Meers, Deborah L. Myers, Kyle Wohlrab, Sarashwathy K Veera, Elizabeth-Ann R Viscione; University of Texas Southwestern Medical Center, USA—Sunil Balgobin, Juanita Bonilla, Agnes Burris, Christy Hegan, David I. Rahn, Joseph Schaffer, Clifford Wai; Duke University Medical Center, Durham, NC, USA—Cindy L Amundsen, Matthew D. Barber, Yasmeen Bruton, Nortorious Coleman-Taylor, Cassandra Shaw, Amie Kawasaki, Tracy O’Dowd, Nazema Y Siddiqui, Anthony Visco, Alison C. Weidner; Kaiser Permanente–San Diego, USA—Kimberly Ferrante, Gouri Diwadkar, Christina Doan, Rebekah Dozier, Lynn Hall, Shawn Menefee, Gisselle Zazueta-Damian; RTI International, USA—Andrew Burd, Kate Burdekin, Ben Carper, Marie Gantz, Kendra Glass, Brenda Hair, Michael Ham, Pooja Iyer, James Pickett, Amanda Shaffer, Taylor Swankie, Yan Chen Tang, Dennis Wallace; University of Alabama at Birmingham, Alabama, USA—Danielle Hays, Kathy Carter, David Ellington, Ryanne Johnson, Alayne Markland, Jeannine McCormick, Holly E. Richter, Robin Willingham; UC San Diego Health, San Diego, CA, USA—Marianna Alperin, Laura Aughinbaugh, Linda Brubaker, Kyle Herrala, Emily S. Lukacz, Charles Nager, Dulce Rodriguez-Ponciano, Erika Ruppert; University of Pennsylvania, USA—Uduak Andy, Lily Arya, Yelizaveta Borodyanskaya, Lorraine Flick, Heidi Harvie, Zandra Kennedy; Magee-Women’s Hospital, Pittsburgh, PA, USA—Lindsey Baranski, Michael Bonidie, Megan Bradley, Pamela Fairchild, Judy Gruss, Beth Klump, Lauren Kunkle, Jacqueline Noel, Pamela Moalli, Halina Zyczynski.
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I.M.: project development, manuscript writing and editing; J.I.-P., B.C., M.G.G.: project development, data management/analysis, manuscript writing and editing; K.Y.D., V.S., M.F.A., M.F.-R., E.K., D.M.: manuscript writing and editing.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development grants HD069006, HD069031, HD069025, HD041261, HD069010, HD069013, HD054214, HD041267, HD054215, and NIH Office of Research on Women’s Health. IRB: IRB-300001240—Title: Univ of Pitt IRB—NeurOmodulaTion for Accidental Bowel LEakage (NOTABLE).
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The abstract was presented as a poster at the 2022 AUGS/IUGA Annual Scientific Meeting in Austin, TX, USA, 14–18 June 2022
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Meyer, I., Iriondo-Perez, J., Dyer, K.Y. et al. Correlation Between Mobile-Application Electronic Bowel Diary and Validated Questionnaires in Women with Fecal Incontinence. Int Urogynecol J 35, 545–551 (2024). https://doi.org/10.1007/s00192-023-05711-1
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DOI: https://doi.org/10.1007/s00192-023-05711-1