Background: The aim of this study was to assess the effect of a 4-week dutasteride treatment on reducing the intraoperative and postoperative bleeding, as well as the amount and duration of irrigation required to clear the urine after transurethral resection of the prostate (TURP) ≥50 g in men receiving the antiplatelet drug (APD).
Materials and methods: This double-blind randomized clinical trial included patients with a prostate size ≥50 g who were indicated for TURP and were already receiving APD. The study was conducted in the Urology Department of Cairo University over a 12-month period. Routine preoperative laboratory investigations were performed in all patients. Moreover, baseline prostate size, serum prostate-specific antigen level, and International Prostate Symptom Score were estimated. The patients were randomly divided into 2 equal groups (groups A and B). Group A, the dutasteride group, received dutasteride (0.5 mg) once daily for 4 weeks. Group B, the placebo group, received a placebo capsule once daily for 4 weeks. Both groups underwent bipolar TURP. Fifteen patients were excluded from the study; 9 patients from group A and 6 patients from group B, either due to drug intolerability or loss follow-up.
Results: The mean blood loss was insignificant between the 2 groups immediately after and 24 hours after surgery (Δ hemoglobin: 1.41 ± 0.63 g/dL vs. 1.48 ± 0.54 g/dL, 2.12 ± 0.70 g/dL vs. 2.31 ± 0.78 g/dL, respectively, p = 0.631, p = 0.333; Δ hematocrit: 2.97% ± 1.51% vs. 3.16% ± 1.36%, 4.96% ± 1.87% vs. 5.73% ± 4.39%, respectively, p = 0.610, p = 0.380). However, there were significant differences in duration of indwelling urethral catheter (5.10 ± 0.55 days vs. 5.80 ± 1.79 days, p = 0.048), duration of bladder irrigation (13.60 ± 2.85 hours vs. 16.33 ± 6.62 hours, p = 0.044), and the amount of saline used for bladder irrigation (11.03 ± 2.30 L vs. 13.87 ± 6.13 L, p = 0.046) between group A and group B. respectively.
Conclusions: Treatment with dutasteride for 4 weeks before TURP in men receiving APD did not significantly reduce intraoperative or postoperative bleeding after TURP but could significantly reduce the duration of indwelling catheter placement, as well as the duration and amount of saline irrigation.
Acknowledgments
The authors would like to thank Dr. Sameeh Zamel, the head of the Urology Department, for his sincere and valuable support.
Statement of ethics
The Ethical Committee of the Urology Department approved the research, as well as the Research Ethical Committee of the Faculty of Medicine, Cairo University (approval date July 20, 2020; code: MS-190-2020). Written in formed consent was obtained from all participants after clear and precise explanation of the indications, possible risks, complications related to the procedure, and the potential benefits of the study. All procedures performed in this study involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
Conflict of interest statement
The authors declare no conflicts of interest.
Author contributions
ES, AHA, AMR: Were the surgeons who performed the procedures;
AM, EH: Revised the statistics;
I NAE, AYA: Were responsible for data collection;
AMR: as the corresponding author, wrote the main manuscript text.
Data availability
The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.
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