G04: Urologicals

ATC G04 urologicals for modelers: urological endpoints are not continuous; placebo response is large and time-varying.

Modified

September 21, 2026

Part of G: Genito-urinary system and sex hormones.

Urological endpoints are not continuous. Symptom scores, voiding diaries and incontinence counts are ordered categorical or count data; fitting E_max to a group mean discards most of the information [1,2].

Placebo response is large and time-varying. In benign prostatic hyperplasia the placebo effect on symptom score has been several times the tamsulosin effect [3], so model its time course rather than treating it as a fixed offset [4].

References

[1]

Lyauk YK, Jonker DM, Hooker AC, Lund TM, Karlsson MO. Bounded integer modeling of symptom scales specific to lower urinary tract symptoms secondary to benign prostatic hyperplasia. The AAPS Journal 2021;23:33. https://doi.org/10.1208/s12248-021-00568-y.

[2]

Lyauk YK, Lund TM, Hooker AC, Karlsson MO, Jonker DM. Item response theory modeling of the international prostate symptom score in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. The AAPS Journal 2020;22:115. https://doi.org/10.1208/s12248-020-00500-w.

[3]

D’Agate S, Wilson T, Adalig B, Manyak M, Palacios-Moreno JM, Chavan C, et al. Model-based meta-analysis of individual international prostate symptom score trajectories in patients with benign prostatic hyperplasia with moderate or severe symptoms. British Journal of Clinical Pharmacology 2020;86:1585–99. https://doi.org/10.1111/bcp.14268.

[4]

Mostafaei H, Janisch F, Mori K, Quhal F, Pradere B, Hajebrahimi S, et al. Placebo response in patients with oral therapy for overactive bladder: A systematic review and meta-analysis. European Urology Focus 2022;8:239–52. https://doi.org/10.1016/j.euf.2021.02.005.