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Observational Study
. 2021 Jun;35(6):761-768.
doi: 10.1089/end.2020.0776. Epub 2020 Nov 16.

Study to Enhance Understanding of Stent-Associated Symptoms: Rationale and Study Design

Charles D Scales Jr  1 , H Henry Lai  2   3 , Alana C Desai  2 , Jodi A Antonelli  4 , Naim M Maalouf  5 , Gregory E Tasian  6   7 , Peter P Reese  7   8 , Michele Curatolo  9 , Kevin Weinfurt  10 , Hussein R Al-Khalidi  11 , Hunter Wessells  12 , Ziya Kirkali  13 , Jonathan D Harper  12
Affiliations
Observational Study

Study to Enhance Understanding of Stent-Associated Symptoms: Rationale and Study Design

Charles D Scales Jr et al. J Endourol. 2021 Jun.

Abstract

Background: Ureteral stents are commonly employed after ureteroscopy to treat urinary stone disease, but the devices impose a substantial burden of stent-associated symptoms (SAS), including pain and urinary side effects. The NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) Urinary Stone Disease Research Network sought to develop greater understanding of SAS causes and severity among individuals treated ureteroscopically for ureteral or renal stones. Materials and Methods: We designed a prospective, observational cohort study comprising adolescents and adults undergoing ureteroscopic intervention for ureteral or renal stones. Participants will undergo detailed symptom assessment using validated questionnaires, a psychosocial assessment, and detailed collection of clinical and operative data. Quantitative sensory testing will be utilized to assess pain sensitization. In addition, a small cohort (∼40 individuals) will participate in semi-structured interviews to develop more granular information regarding their stent symptoms and experience. Biospecimens (blood and urine) will be collected for future research. Results: The Study to Enhance Understanding of sTent-associated Symptoms (STENTS) enrolled its first participant in March 2019 and completed nested qualitative cohort follow-up in August 2019. After a planned pause, enrollment for the main study cohort resumed in September 2019 and is expected to be completed in 2021. Conclusion: STENTS is expected to provide important insights into the mechanisms and risk factors for severe ureteral SAS after ureteroscopy. These insights will generate future investigations to mitigate the burden of SAS among individuals with urinary stone disease.

Keywords: stent-associated symptoms; ureteral stents; ureteroscopy; urinary stone disease.

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Conflict of interest statement

Dr. Antonelli reported relationships with the following entities: Boston Scientific Corp, Cook Medical (Advisory Board). Dr. Tasian reported relationships with the following entities: Dicerna (advisory board, scientific study), Alnylam (advisory board), Novome (advisory board), and Allena Pharmaceuticals (consultant). No other authors reported disclosures relevant to this article.

Figures

FIG. 1.
FIG. 1.
Conceptual model of ureteral stent-associated symptoms.
FIG. 2.
FIG. 2.
STENTS study schema. QST = quantitative sensory testing; Sx = symptoms.
See this image and copyright information in PMC

References

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