Background: The lifetime occurrence of urinary stones is approximately 1%-15%, and the peak age of occurrence is 30 years. Approximately one fifths of urinary tract stones are found in the ureter, of which two thirds are in the distal ureter. Many drugs, including phosphodiesterase-5 inhibitors (PDE5Is) and α-blockers, are used to relax the smooth muscles in medical expulsive therapy (MET). We aimed to compare the combination of tadalafil and tamsulosin versus tadalafil alone as MET for stones in the L1/3 ureter of 10 mm or less.
Materials and methods: A total of 150 patients with L1/3 ureteric stones measuring 10 mm or less were enrolled in the study and randomly assigned to one of 3 equal groups using a computer-generated random number. Patients in group A prescribed tadalafil 10 mg/d. However, those in group B were prescribed tamsulosin 0.4 mg and tadalafil 10 mg/d, whereas those in group C received a placebo once daily. Stone expulsion rate and pain recurrence were evaluated after 14 days.
Results: The stone expulsion rate was significantly higher in the tadalafil and tamsulosin groups and the tamsulosin group than in the placebo group in the current study by 68% in the combination group, 64% in the tadalafil alone group, and 42% in the placebo group (p = 0.019). In the current study, a combination was associated with lower pain recurrence than tadalafil alone or placebo, with means of 1.06, 1.9, 2.98 (with a p value of 0.001). Stone size was not effective in any group.
Conclusions: The combination of PDE5Is and α-blockers effectively increases the expulsion of lower ureteric stones (5-10 mm), but with the same effect as PDE5Is alone, with the advantage of decreasing pain recurrence. Stone size did not affect the expulsion rate in patients who received MET for stones less than 1 cm in size.
Acknowledgments
None.
Statement of ethics
The study methodology and protocol were approved by the institutional review board of the Assiut Faculty of Medicine. This trial was registered at ClinicalTrials.gov (NCT05150899). Written informed consent was obtained from all the participants. The research was conducted in accordance with the principles embodied in the Declaration of Helsinki and in accordance with local statutory requirements.
Conflict of interest statement
The authors declare that they have no conflicts of interest.
Funding source
None.
Author contributions
AR: Conceived and designed the analysis;
MK: Collected the data;
MI: Contributed data or analysis tools;
YMA: Performed the analysis;
MZ: Wrote the paper.
Data avaliability
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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