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A prospective evaluation of patient-reported outcomes during follow-up of ureteral stones managed with medical expulsive treatment (MET)

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Abstract

Patient-reported outcomes (PROs) for ureteral stones predominantly assess the pain. Despite the lack of evidence, multiple trials studying the efficacy of medical expulsive therapy (MET) have used PROs to define spontaneous stone passage (SSP). We aim to objectively evaluate the accuracy of PROs to predict successful SSP and the probability of patient’s symptom resolution after stone passage. A single-center, prospective observational study recruiting adults with isolated, uncomplicated, ≤ 10 mm ureteral calculus was conducted. All patients received 4 weeks of MET, and SSP was confirmed by low-dose non-contrast-enhanced computed tomography (NCCT). The accuracy of PROs: “pain cessation,” “decreased pain,” “stone seen,” and “stone capture” to predict successful SSP were evaluated in 1 month. The patient’s symptom resolution rate was assessed at 1 and 4-month follow-ups. A total of 171 patients were included, and the overall SSP rate was 66.4% (n = 99). Patient-reported pain cessation, stone visualization, and stone capture were associated with successful SSP, but their accuracy was 59, 53, and 43%, respectively. Moreover, 25% of patients reporting complete pain cessation still harbored ureteral calculus. Pain resolved in 91% of patients after SSP at a 4-month follow-up. While hematuria and nausea resolved in all patients, lower urinary tract symptoms (LUTS) were not resolved in 17% of patients. We concluded that patient-reported pain cessation, stone visualization, and stone capture predict successful SSP, but confirmatory imaging is required due to the poor accuracy of these measures. The significant rates of non-pain-related symptoms indicate their significant contribution to patient morbidity.

Clinical Trial Registration: Registered in Clinical Trial Registry of India (CTRI), Registration number: CTRI/2020/10/028777 (29th October 2020).

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Data Availability

The data supporting the study findings are available on request from the corresponding author, Dr. Swarnendu Mandal. The data are not publicly available because they contain information that could compromise study participants’ privacy and consent.

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Authors and Affiliations

  1. Department of Urology, All India Institute of Medical Sciences, Bhubaneswar, India

    Abhishek Pandey, Swarnendu Mandal, Santosh Kumaraswamy, Abhay Singh Gaur, Manoj K. Das & Prasant Nayak

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  1. Abhishek Pandey
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  2. Swarnendu Mandal
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  3. Santosh Kumaraswamy
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  4. Abhay Singh Gaur
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  5. Manoj K. Das
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  6. Prasant Nayak
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Contributions

Conceptualization: SM, AP; methodology: AP, SM, PN; software: NA; validation: MKD, PN; formal analysis: AP, SK, ASG; investigation: AP, SM; resources: NA; data curation: AP, SK, ASG; writing—original draft: AP, SK, ASG; writing—review and editing: SM, MKD, PN; visualization: AP, SM; supervision: SM, MKD, PN; project administration: AP, SM.

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Correspondence to Swarnendu Mandal.

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Obtained [Reference number: IEC/ AIIMS BBSR/ PG Thesis/ 2020–21/ 32] [IEC Registration number: ECR/ 534/ Inst/ OD/ 2014/ RR-20].

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Pandey, A., Mandal, S., Kumaraswamy, S. et al. A prospective evaluation of patient-reported outcomes during follow-up of ureteral stones managed with medical expulsive treatment (MET). Urolithiasis 51, 56 (2023). https://doi.org/10.1007/s00240-023-01428-4

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