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Hashem A. et al., 2022: A randomized trial of adjuvant tamsulosin as a medical expulsive therapy for renal stones after shock wave lithotripsy.

Hashem A, El-Assmy AM, Sharaf DE, Elgamal M, Elzalouey AE, Laymon M
Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
2Urology Department, National Nephrology and Urology Institute, Cairo, Egypt.
Urology Department, International Medical Center, Cairo, Egypt.
Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.
Radiology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.

Abstract

Adjuvant medical expulsive therapy (MET) for shock wave lithotripsy (SWL) is controversial. With limited use of the computed tomography (CT), the stone free rate (SFR) become overestimated. Herein we evaluate tamsulosin post-SWL for renal stone using the CT to assess SFR. A randomized controlled trial (NCT05032287) was carried out for renal stone patients amenable for SWL. Patients were allocated after 1st session of SWL to receive tamsulosin 0.4 mg or placebo once daily from the 1st day of SWL and for 3-months or becoming stone free. The primary outcome was SFR, defined by presence of residual fragments (RF) ≤ 3 mm (3C-SFR). The 3C-SFR were 73.8% and 59.6% in tamsulosin and placebo groups, respectively (p = 0.03). The median (IQR) pain scores were 3 (3, 5) and 5 (3, 6) in tamsulosin and placebo groups, respectively (p = 0.04), However, the post-SWL complication and add-on analgesia needed showed no significance differences between groups. The median time for stone free were 30 days (95% CI: 27.29-32.71) in tamsulosin arm, and 36 days (95% CI: 31.01-40.99) in placebo arm, HR = 1.42 (95% CI: 1.02-1.98). Tamsulosin has more reversible adverse effect, compared to placebo (p = 0.03). In our study, the use of tamsulosin as MET following SWL facilitates expulsion of retained residual fragments. Tamsulosin shortens time to reach stone free, decreases pain scores. However, tamsulosin does not affect the add-on IV analgesics and have more reversible adverse effect, compared to placebo.
Urolithiasis. 2022 May 16. doi: 10.1007/s00240-022-01330-5. Online ahead of print. PMID: 35576073

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Comments 1

Peter Alken on Friday, 09 December 2022 09:30

I wonder why the question is still an interesting topic for urologists after the many studies and reviews.
As stated by the authors so far no well-designed RCT has used CT for the detection of residual stone fragments at least until the latest review (1) in 2021.
In the present study, CT was used to document SFR. Patients were randomised after the first session. To get a real live impression, it would have been nice to know how many patients were excluded and why. There are also no details on the number of ESWL-sessions and the number of shots in the two groups.
Otherwise, the present study is well done and will make it into guidelines. However, I doubt if it will change urological habits of prescribing α-blockers
despite the documented low quality of publications on that matter (2).


1 Ouyang W, Sun G, Long G, Liu M, Xu H, Chen Z, Ye Z, Li H, Zhang Y. Adjunctive medical expulsive therapy with tamsulosin for repeated
extracorporeal shock wave lithotripsy: a systematic review and meta-analysis. Int Braz J Urol. 2021 Jan-Feb;47(1):23-35. doi: 10.1590/S1677-5538.IBJU.2020.0093. PMID: 32459454; PMCID: PMC7712709.
Free PMC article.
2 Tzelves L, Chatzikrachtis N, Lazarou L, Mourmouris P, Pinitas A, Tsirkas K, Petropoulos O, Berdempes M, Feretzakis G, Glykas I, Fragkoulis C, Varkarakis I, Skolarikos A. Fragility index of urological literature regarding medical expulsive treatment. World J Urol. 2021 Oct;39(10):3741-3746. doi: 10.1007/s00345-021-03725-2

Peter Alken

I wonder why the question is still an interesting topic for urologists after the many studies and reviews. As stated by the authors so far no well-designed RCT has used CT for the detection of residual stone fragments at least until the latest review (1) in 2021. In the present study, CT was used to document SFR. Patients were randomised after the first session. To get a real live impression, it would have been nice to know how many patients were excluded and why. There are also no details on the number of ESWL-sessions and the number of shots in the two groups. Otherwise, the present study is well done and will make it into guidelines. However, I doubt if it will change urological habits of prescribing α-blockers despite the documented low quality of publications on that matter (2). 1 Ouyang W, Sun G, Long G, Liu M, Xu H, Chen Z, Ye Z, Li H, Zhang Y. Adjunctive medical expulsive therapy with tamsulosin for repeated extracorporeal shock wave lithotripsy: a systematic review and meta-analysis. Int Braz J Urol. 2021 Jan-Feb;47(1):23-35. doi: 10.1590/S1677-5538.IBJU.2020.0093. PMID: 32459454; PMCID: PMC7712709. Free PMC article. 2 Tzelves L, Chatzikrachtis N, Lazarou L, Mourmouris P, Pinitas A, Tsirkas K, Petropoulos O, Berdempes M, Feretzakis G, Glykas I, Fragkoulis C, Varkarakis I, Skolarikos A. Fragility index of urological literature regarding medical expulsive treatment. World J Urol. 2021 Oct;39(10):3741-3746. doi: 10.1007/s00345-021-03725-2 Peter Alken
Thursday, 28 March 2024