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Effect of tamsulosin versus tamsulosin plus tadalafil on renal calculus clearance after shock wave lithotripsy: An open-labelled, randomised, prospective study |
Siddalingeshwar Neeli( )
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Department of Urology, Jawaharlal Nehru Medical College, Belagavi, India |
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Abstract Objectives: To compare the efficacy of tamsulosin versus tamsulosin plus tadalafil in achieving clearance of fragments after shock wave lithotripsy (SWL) to treat renal calculi. Methods: Between January 2016 to December 2017, 140 patients with solitary, non-branched, non-lower calyceal renal calculus and measuring less than 20 mm and treated with SWL were randomized to tamsulosin (group A) or tamsulosin plus tadalafil (group B). Therapy was given for a period of 4 weeks. Stone clearance rate, analgesic requirement, occurrence of steinstrasse, need for auxiliary procedures (endoscopic treatment), and adverse effects of drugs were recorded. Results: The overall clearance rate was 72.5% (50/69) in the group A and 90.1% (64/71) in the group B (p=0.007). For stones up to 12 mm, the difference in the clearance rate was significant (p=0.039) while it was not so for stones larger than 12 mm (p=0.151). There was no statistically significant difference between the two groups with regards to analgesic requirement (p=0.94), occurrence of steinstrasse (p=0.101), need for auxiliary procedures (p=0.76), and adverse effects of the drugs (p=0.148). Conclusion: Our study shows that adjunctive medical expulsive therapy with tamsulosin and tadalafil achieves better clearance rate than tadalafil alone in patients receiving SWL for renal stones.
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Received: 29 April 2020
Available online: 20 October 2021
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Corresponding Authors:
Siddalingeshwar Neeli
E-mail: sineeli@gmail.com
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CONSORT diagram.
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Characteristic | Group A (n=69) | Group B (n=71) | p-Value | Age, mean±SD, year | 40.00±10.08 | 41.32±10.22 | 0.442 | Gender, n | Male | 48 | 49 | 0.629 | Female | 21 | 22 | | BMI, mean±SD, kg/m2 | Male | 22.40±3.03 | 22.57±3.49 | 0.781 | Female | 23.21±2.62 | 22.34±2.69 | Side, n | Right | 34 | 37 | 0.843 | Left | 35 | 34 | Stone location, n | Upper calyx | 12 | 14 | 0.923 | Mid calyx | 25 | 26 | Renal pelvis | 32 | 31 | Stone size, mean±SD, mm | 11.75±2.17 | 11.97±2.13 | 0.550 | Stone size, n (%) | 6-12 mm | 46 (66.7%) | 46 (64.7%) | 0.550 | 13-18 mm | 23 (33.3%) | 25 (35.3%) | Stone density, mean±SD, HU | 854±69 | 861±71 | 0.64 | Pain score, mean±SD | 5.70±1.27 | 5.72±1.21 | 0.914 |
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Baseline demographics and clinical characteristics at presentation.
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Stone size | Stone clearance | Treatment group, n | Total, n | p-Value | Group A (tamsulosin) | Group B (tamsulosin+tadalafil) | Up to 12 mm | Complete | 37 | 45 | 82 | 0.007 | Partial | 9 | 1 | 10 | Subtotal | 46 | 46 | 92 | >12 mm | Complete | 13 | 19 | 32 | 0.153 | Partial | 10 | 6 | 16 | Subtotal | 23 | 25 | 48 | Overall | Complete | 50 | 64 | 114 | 0.007 | Partial | 19 | 7 | 26 | Total | 69 | 71 | 140 |
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Comparison of stone clearance rates.
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Drug side effect | Treatment group, n | p-Value | Group A (tamsulosin) | Group B (tamsulosin+tadalafil) | None | 48 | 58 | 0.094 | Headache | 6 | 8 | 0.612 | Dizziness | 11 | 3 | 0.021 | Vomiting | 1 | 1 | 1.000 | Nausea | 3 | 1 | 0.397 | Total | 69 | 71 | NA |
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Comparison of drug side effects.
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Stone size | Treatment group, n | Total, n | p-Value | Group A (tamsulosin) | Group B (tamsulosin +tadalafil) | Up to 12 mm | Steinstrasse | 2 | 2 | 4 | 0.692 | No steinstrasse | 44 | 44 | 88 | | Subtotal | 46 | 46 | 92 | | >12 mm | Steinstrasse | 11 | 5 | 16 | 0.041 | No steinstrasse | 12 | 20 | 32 | | Subtotal | 23 | 25 | 48 | | Overall | Steinstrasse | 13 | 7 | 20 | 0.101 | No steinstrasse | 56 | 84 | 120 | | Subtotal | 69 | 71 | 140 | |
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Incidence of steinstrasse.
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