Bowel and bladder function in infant toilet training (BABITT) - protocol for a randomized, two-armed intervention study

Terese Nilsson, Anna Leijon, Ulla Sillén, Anna-Lena Hellström, Barbro Hedin Skogman, Terese Nilsson, Anna Leijon, Ulla Sillén, Anna-Lena Hellström, Barbro Hedin Skogman

Abstract

Background: In the last decades, the average age for toilet training has increased in the western world. It is suggested that the postponed initiation of toilet training is a contributing factor to problems related to bowel and bladder control. Functional gastrointestinal and urinary tract disorders are prevalent in childhood, causing suffering in affected children and for their families, and consuming healthcare resources. To evaluate whether assisted infant toilet training can prevent functional gastrointestinal and urinary tract disorders in young children, we are conducting a randomized intervention study with a 4-year follow-up.

Methods: This randomized two-armed intervention study will include 268 Swedish infants recruited at six child healthcare centers in Region Dalarna located in the central part of Sweden. The intervention entails parents being instructed and practicing assisted infant toilet training with their child. Children are randomized to start assisted infant toilet training at 0-2 months or at 9-11 months of age. The primary objective is to determine the efficacy of assisted infant toilet training initiated at 0-2 months on the prevalence of functional gastrointestinal disorders (defined as infant colic, infant dyschezia and/or functional constipation) up to the age of 9 months. Secondary objectives are to evaluate whether assisted toilet training initiated during the first year of life reduce the prevalence of functional gastrointestinal disorders (defined as functional constipation, gastrointestinal symptoms and/or stool toileting refusal) and urinary tract disorders (defined as bladder dysfunction and/or urinary tract infections) up to the age of 4 years. Furthermore, infant-to-mother attachment, parental stress, the toilet training process and overall parental experiences will be evaluated/explored.

Discussion: This protocol article presents the rationale and design of a randomized two-armed intervention study that will determine the efficacy of assisted infant toilet training on functional gastrointestinal disorders up to the age of 9 months. Furthermore, the study will evaluate whether assisted infant toilet training during the first year of life can prevent functional gastrointestinal and urinary tract disorders in children up to 4 years of age. If effective, assisted infant toilet training could be recommended in child healthcare settings and new evidence-based guidelines on infant toilet training could be implemented.

Trial registration: The study protocol was retrospectively registered at ClinicalTrials. gov ( NCT04082689 ), initial release June 12th, 2019).

Keywords: Assisted infant toilet training; Bladder dysfunction; Child health care; Children; Functional constipation; Infant colic; Infant dyschezia; Infant-to-mother attachment; Parental stress; Stool toileting refusal.

Conflict of interest statement

The authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Time schedule over measuring points for the questionnaires (web surveys) (X) including the external validated instruments Maternal Postnatal Attachment Scale (MPAS), Swedish Parenthood Stress Questionnaire (SPSQ), Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQLGastro), and rectal ultrasound and infant behavioral diary (+) in the BABITT-study

References

    1. Bakker E, Wyndaele JJ. Changes in the toilet training of children during the last 60 years: the cause of an increase in lower urinary tract dysfunction? BJU Int. 2000;86(3):248–252. doi: 10.1046/j.1464-410x.2000.00737.x.
    1. Klackenberg G. A prospective longitudinal study of children. Data on psychic health and development up to 8 years of age. Acta Paediatr Scand Suppl. 1971;224:1–239.
    1. Jansson UB, Hanson M, Sillen U, Hellstrom AL. Voiding pattern and acquisition of bladder control from birth to age 6 years--a longitudinal study. J Urol. 2005;174(1):289–293. doi: 10.1097/01.ju.0000161216.45653.e3.
    1. Barone JG, Jasutkar N, Schneider D. Later toilet training is associated with urge incontinence in children. J Pediatr Urol. 2009;5(6):458–461. doi: 10.1016/j.jpurol.2009.05.012.
    1. Hodges SJ, Richards KA, Gorbachinsky I, Krane LS. The association of age of toilet training and dysfunctional voiding. Res Rep Urol. 2014;6:127–130.
    1. Bakker E, Van Gool JD, Van Sprundel M, Van Der Auwera C, Wyndaele JJ. Results of a questionnaire evaluating the effects of different methods of toilet training on achieving bladder control. BJU Int. 2002;90(4):456–461. doi: 10.1046/j.1464-410X.2002.02903.x.
    1. Taubman B. Toilet training and toileting refusal for stool only: a prospective study. Pediatrics. 1997;99(1):54–58. doi: 10.1542/peds.99.1.54.
    1. Taubman B, Blum NJ, Nemeth N. Children who hide while defecating before they have completed toilet training: a prospective study. Arch Pediatr Adolesc Med. 2003;157(12):1190–1192. doi: 10.1001/archpedi.157.12.1190.
    1. Bakker E, van Gool J, van Sprundel M, van der Auwera JC, Wyndaele JJ. Risk factors for recurrent urinary tract infection in 4,332 Belgian schoolchildren aged between 10 and 14 years. Eur J Pediatr. 2004;163(4–5):234–238. doi: 10.1007/s00431-003-1258-z.
    1. Duong TH, Jansson UB, Hellstrom AL. Vietnamese mothers' experiences with potty training procedure for children from birth to 2 years of age. J Pediatr Urol. 2013;9(6 Pt A):808–814. doi: 10.1016/j.jpurol.2012.10.023.
    1. Rugolotto S, Sun M, Boucke L, Chen BB, Tato L. Assisted infant toilet training: is it time for a critical revision? Pediatr Med Chir. 2008;30(5):233–238.
    1. Wennergren HM, Oberg BE, Sandstedt P. The importance of leg support for relaxation of the pelvic floor muscles. A surface electromyograph study in healthy girls. Scand J Urol Nephrol. 1991;25(3):205–213. doi: 10.3109/00365599109107948.
    1. Sikirov D. Comparison of straining during defecation in three positions: results and implications for human health. Dig Dis Sci. 2003;48(7):1201–1205. doi: 10.1023/A:1024180319005.
    1. RikshandbokenBarnhälsovård. Rikshandboken barnhälsovård: Socialstyrelsen; 2018. [Available from: . Accessed 3 Nov 2018.
    1. Wolke D, Bilgin A, Samara M. Systematic review and Meta-analysis: fussing and crying durations and prevalence of colic in infants. J Pediatr. 2017;185:55–61 e4. doi: 10.1016/j.jpeds.2017.02.020.
    1. Zeevenhooven J, Browne PD, L'Hoir MP, de Weerth C, Benninga MA. Infant colic: mechanisms and management. Nat Rev Gastroenterol Hepatol. 2018;15(8):479–496. doi: 10.1038/s41575-018-0008-7.
    1. Zeevenhooven J, Koppen IJ, Benninga MA. The new Rome IV criteria for functional gastrointestinal disorders in infants and toddlers. Pediatr Gastroenterol Hepatol Nutr. 2017;20(1):1–13. doi: 10.5223/pghn.2017.20.1.1.
    1. Duong TH, Jansson UB, Holmdahl G, Sillen U, Hellstrom AL. Urinary bladder control during the first 3 years of life in healthy children in Vietnam--a comparison study with Swedish children. J Pediatr Urol. 2013;9(6 Pt A):700–706. doi: 10.1016/j.jpurol.2013.04.022.
    1. Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, et al. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the standardization committee of the international Children's continence society. Neurourol Urodyn. 2016;35(4):471–481. doi: 10.1002/nau.22751.
    1. Hellstrom AL, Hanson E, Hansson S, Hjalmas K, Jodal U. Micturition habits and incontinence in 7-year-old Swedish school entrants. Eur J Pediatr. 1990;149(6):434–437. doi: 10.1007/BF02009667.
    1. Sureshkumar P, Jones M, Cumming R, Craig J. A population based study of 2,856 school-age children with urinary incontinence. J Urol. 2009;181(2):808–815. doi: 10.1016/j.juro.2008.10.044.
    1. Loening-Baucke V. Urinary incontinence and urinary tract infection and their resolution with treatment of chronic constipation of childhood. Pediatrics. 1997;100(2 Pt 1):228–232. doi: 10.1542/peds.100.2.228.
    1. Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011;25(1):3–18. doi: 10.1016/j.bpg.2010.12.010.
    1. Kovacic K, Sood MR, Mugie S, Di Lorenzo C, Nurko S, Heinz N, et al. A multicenter study on childhood constipation and fecal incontinence: effects on quality of life. J Pediatr. 2015;166(6):1482–7 e1. doi: 10.1016/j.jpeds.2015.03.016.
    1. Belsey J, Greenfield S, Candy D, Geraint M. Systematic review: impact of constipation on quality of life in adults and children. Aliment Pharmacol Ther. 2010;31(9):938–949.
    1. van den Berg MM, van Rossum CH, de Lorijn F, Reitsma JB, Di Lorenzo C, Benninga MA. Functional constipation in infants: a follow-up study. J Pediatr. 2005;147(5):700–704. doi: 10.1016/j.jpeds.2005.05.032.
    1. van Ginkel R, Reitsma JB, Buller HA, van Wijk MP, Taminiau JA, Benninga MA. Childhood constipation: longitudinal follow-up beyond puberty. Gastroenterology. 2003;125(2):357–363. doi: 10.1016/S0016-5085(03)00888-6.
    1. Bongers ME, van Wijk MP, Reitsma JB, Benninga MA. Long-term prognosis for childhood constipation: clinical outcomes in adulthood. Pediatrics. 2010;126(1):e156–e162. doi: 10.1542/peds.2009-1009.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Schulz KF, Altman DG, Moher D, Group C CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. Wettergren B, Blennow M, Hjern A, Soder O, Ludvigsson JF. Child health Systems in Sweden. J Pediatr. 2016;177S:S187–S202. doi: 10.1016/j.jpeds.2016.04.055.
    1. Ulrika C. Bebis på pottan, din guide till EC och potträning: Blöjfri bebis; 2014; Mjukband (ISBN: 9789176119020).
    1. RikshandbokenBarnhälsovård. Rikshandboken barnhälsovård 2019. Available from: (). Accessed 9 Dec 2019.
    1. Landgren K, Kvorning N, Hallstrom I. Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study. Acupunct Med. 2010;28(4):174–179. doi: 10.1136/aim.2010.002394.
    1. Varni JW, Bendo CB, Denham J, Shulman RJ, Self MM, Neigut DA, et al. PedsQL gastrointestinal symptoms module: feasibility, reliability, and validity. J Pediatr Gastroenterol Nutr. 2014;59(3):347–355. doi: 10.1097/MPG.0000000000000414.
    1. Brautigam M, Dellenmark-Blom M, Gatzinsky V, Bergstrom J, Abrahamsson K. Linguistic and content validity of the Swedish version of the PedsQL gastrointestinal symptoms scales and symptoms module for paediatric patients. Acta Paediatr. 2021;110(11):3124–3130. doi: 10.1111/apa.16066.
    1. Joensson IM, Siggaard C, Rittig S, Hagstroem S, Djurhuus JC. Transabdominal ultrasound of rectum as a diagnostic tool in childhood constipation. J Urol. 2008;179(5):1997–2002. doi: 10.1016/j.juro.2008.01.055.
    1. Sillen U, Sjostrom S, Doroszkiewicz M, Ekdahl H, Dellenmark-Blom M. Development and validation of symptom score for Total bladder-bowel dysfunction: subscales for overactive bladder and dysfunctional voiding. J Urol. 2020;204(6):1333–1340. doi: 10.1097/JU.0000000000001154.
    1. Condon JT, Corkindale CJ. The assessment of parent-to-infant attachment: development of a self-report questionnaire instrument. J Reprod Infant Psychol. 1998;16(1):57–76. doi: 10.1080/02646839808404558.
    1. Ostberg M, Hagekull B, Wettergren S. A measure of parental stress in mothers with small children: dimensionality, stability and validity. Scand J Psychol. 1997;38(3):199–208. doi: 10.1111/1467-9450.00028.
    1. Abidin RR, Brunner JF. Development of a parenting Alliance inventory. J Clin Child Psychol. 1995;24(1):31–40. doi: 10.1207/s15374424jccp2401_4.
    1. MediCaseAB. Available from: . Accessed 3 Dec 2021.
    1. Polit DF, Beck CT, Owen SV. Is the CVI an acceptable indicator of content validity? Appraisal and recommendations. Res Nurs Health. 2007;30(4):459–467. doi: 10.1002/nur.20199.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa