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      // =========================================================
      // TITLE PAGE
      // =========================================================
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        children: [new TextRun({ text: "EFFICACY AND SAFETY OF TAMSULOSIN, TADALAFIL, AND THEIR COMBINATION AS MEDICAL EXPULSIVE THERAPY FOR LOWER URETERIC STONES STRATIFIED BY STONE SIZE (5-7 mm AND 8-10 mm)", bold: true, font: "Times New Roman", size: 28 })],
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        children: [tb("DR. SAGHEER ANJUM")],
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        children: [tb("MS UROLOGY")],
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        children: [t("under supervision of")],
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        children: [tb("Dr. Khalid Khan"), t(" MBBS, MS"), t(" Assistant Professor Of Urology"), t(" Sahiwal Teaching Hospital, Sahiwal")],
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      // =========================================================
      // TRACK CHANGES NOTICE
      // =========================================================
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      // =========================================================
      // PROJECT SUMMARY
      // =========================================================
      h("PROJECT SUMMARY"),
      p([
        t("Ureteric stones are among the most frequent urological conditions and a common cause of sudden, severe flank pain leading to hospital visits. While many small stones may pass without intervention, spontaneous passage is often delayed and accompanied by significant discomfort. Medical expulsive therapy (MET) has therefore become a preferred approach to aid clearance and reduce the need for surgical procedures. Tamsulosin, an alpha-blocker, is widely used for this purpose, and recent evidence suggests that tadalafil, a phosphodiesterase-5 inhibitor, may further improve outcomes by enhancing ureteral relaxation and peristalsis. Despite these promising findings, the direct comparison of tamsulosin alone versus its combination with tadalafil has not been adequately studied in our population. "),
        t("This study is designed to address the research question: does adding tadalafil to tamsulosin improve the success of medical expulsive therapy in lower ureteric stones compared to tamsulosin alone? "),
        add("Furthermore, in accordance with reviewer recommendations, a third group receiving tadalafil alone has been added to provide a more complete comparative evaluation. "),
        t("The working hypothesis is that the combination regimen will result in higher rates of stone clearance, faster expulsion, fewer colic episodes, and lower analgesic requirements. The primary objective is to evaluate and compare the expulsion rate among the "),
        del("two"),
        add("three"),
        t(" treatment groups. Secondary objectives include assessment of expulsion time, pain episodes, analgesic use, and potential adverse effects of the medications. "),
        t("The study population will "),
        add("primarily be stratified according to stone size into two sub-groups (5-7 mm and 8-10 mm) before further stratification into three pharmacological treatment groups. "),
        t("This will be a randomized controlled trial involving patients aged 18 to 60 years with a single distal ureteric stone measuring between 5 and 10 mm. A calculated sample size will be equally divided into "),
        del("two"),
        add("three"),
        t(" arms. Participants will be recruited through consecutive sampling, and random allocation will be used to assign them to receive tamsulosin alone, tadalafil alone, or tamsulosin plus tadalafil. Data will be analyzed using appropriate statistical tests. A significance level of less than 0.05 will be applied."),
      ]),
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      // =========================================================
      // INTRODUCTION
      // =========================================================
      h("INTRODUCTION"),
      p([t("Urolithiasis, or urinary tract stone disease, is a common and growing health issue worldwide, with a lifetime prevalence of up to 15% and a higher incidence in men than women (Gnyawali et al., 2020, Tayab et al., 2022, Liu et al., 2018). In Pakistan, the burden is particularly significant, as the country lies within the so called \"Stone Belt\" of Asia. Recent local studies highlight that lower ureteric stones are frequently encountered in clinical practice, especially among adults aged 30-50 years, and are associated with considerable morbidity, repeated emergency visits, and a risk of chronic kidney disease if not managed effectively (Tayab et al., 2022). The high recurrence rate and the impact on quality of life make the management of lower ureteric stones a pressing concern for both patients and healthcare providers in Pakistan (Tayab et al., 2022).")]),
      p([t("Medical expulsive therapy (MET) has become a cornerstone in the non-surgical management of lower ureteric stones, aiming to facilitate spontaneous stone passage, reduce pain, and minimize the need for invasive procedures (Kumar et al., 2022, Dogha et al., 2025). Tamsulosin, an α-1 adrenergic receptor antagonist, is widely used for this purpose due to its ability to relax ureteric smooth muscle. However, despite its benefits, a substantial proportion of patients still experience delayed stone passage, persistent pain, and frequent healthcare utilization, indicating that tamsulosin monotherapy may not be sufficient for all cases (Kumar et al., 2022, Gnyawali et al., 2020). Recent research has explored the addition of tadalafil, a phosphodiesterase-5 inhibitor, to tamsulosin, hypothesizing that their complementary mechanisms could enhance stone expulsion rates and reduce pain episodes. While several recent randomized controlled trials including those conducted in Pakistan have shown promising results for combination therapy, some studies report only modest improvements or no significant difference in expulsion rates, leading to ongoing debate about the true clinical benefit of adding tadalafil (Gnyawali et al., 2020, Tayab et al., 2022, Kumar et al., 2022).")]),
      p([t("Given the high disease burden in Pakistan, the limitations of current monotherapy, and the mixed evidence regarding combination therapy, there is a clear need for further research to clarify whether tamsulosin plus tadalafil offers meaningful advantages over tamsulosin alone or over tadalafil alone. A robust, locally relevant study can help resolve these uncertainties and guide evidence-based practice. Establishing the most effective and patient-centered approach to MET for lower ureteric stones is essential for improving outcomes, reducing healthcare costs, and enhancing quality of life for patients in Pakistan. This strong rationale underpins the present study, which aims to provide definitive answers to this important clinical question (Dogha et al., 2025, Kumar et al., 2022, Tayab et al., 2022).")]),
      new Paragraph({ children: [new PageBreak()] }),

      // =========================================================
      // LITERATURE REVIEW
      // =========================================================
      h("LITERATURE REVIEW"),
      p([t("Lower ureteric stones are a common and increasingly prevalent cause of acute urological admissions worldwide, with a significant impact on patient quality of life and healthcare systems. The global burden of urolithiasis is rising, with recurrence rates estimated at up to 50% within 10 years, and a notable increase in emergency department visits for stone disease over the past two decades (Balawender et al., 2024, Siener, 2021). In Pakistan and other South Asian countries, the prevalence is particularly high due to environmental, dietary, and genetic factors, and the disease often affects adults in their most productive years, leading to substantial socioeconomic consequences (Ziaeefar et al., 2023, Balawender et al., 2024).")]),
      p([t("Medical expulsive therapy (MET) has become a widely discussed approach for managing lower ureteric stones, aiming to facilitate spontaneous stone passage and reduce the need for surgical intervention. Alpha-blockers, particularly tamsulosin, have been the cornerstone of MET, with numerous studies and meta-analyses supporting their use (De Coninck et al., 2019). A recent systematic review and meta-analysis of 56 randomized controlled trials involving nearly 9,400 patients found that tamsulosin significantly increased stone expulsion rates, shortened expulsion time, reduced the incidence of ureteral colic, and decreased the need for further intervention, especially for stones larger than 5 mm. Importantly, tamsulosin did not increase the risk of adverse effects compared to controls, supporting its safety profile for this indication (Cui et al., 2019). Similarly, a 2018 Cochrane review concluded that alpha-blockers likely increase stone clearance, especially for stones greater than 5 mm, but may also slightly increase the risk of adverse events (Campschroer et al., 2018).")]),
      p([t("Despite these positive findings, the evidence base for MET is marked by significant controversy and inconsistency. High-quality, large, placebo-controlled randomized trials have sometimes failed to demonstrate a clear benefit of alpha-blockers over placebo for stone passage, even for distal ureteral stones greater than 5 mm (De Coninck et al., 2019). Recent research has also explored the use of combination therapy, such as tamsulosin plus tadalafil, to enhance the efficacy of MET. New randomized clinical trials suggest that adding tadalafil, a phosphodiesterase-5 inhibitor, to tamsulosin can significantly increase stone expulsion rates, reduce expulsion time, and lower the frequency of pain episodes and hospital visits compared to tamsulosin alone (Türk et al., 2020, Kirchner et al., 2020). However, the number of high-quality studies on combination therapy remains limited, and questions persist regarding optimal patient selection, cost-effectiveness, and the generalizability of findings across different populations (Reda et al., 2023). Furthermore, most studies have been conducted in high-income countries, with relatively few high-quality trials from South Asia, including Pakistan, where the disease burden is highest and healthcare resources are often limited.")]),
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      // =========================================================
      // OBJECTIVES
      // =========================================================
      h("OBJECTIVES"),
      p([t("To compare the EFFICACY AND SAFETY OF TAMSULOSIN, TADALAFIL, AND THEIR COMBINATION AS MEDICAL EXPULSIVE THERAPY FOR LOWER URETERIC STONES STRATIFIED BY STONE SIZE (5-7 mm AND 8-10 mm)")]),
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      // =========================================================
      // HYPOTHESIS
      // =========================================================
      h("HYPOTHESIS"),
      hBold("Null Hypothesis"),
      p([t("There is no difference in the EFFICACY AND SAFETY OF TAMSULOSIN, TADALAFIL, AND THEIR COMBINATION AS MEDICAL EXPULSIVE THERAPY FOR LOWER URETERIC STONES STRATIFIED BY STONE SIZE (5-7 mm AND 8-10 mm)")]),
      hBold("Alternative Hypothesis"),
      p([t("There is a difference in the EFFICACY AND SAFETY OF TAMSULOSIN, TADALAFIL, AND THEIR COMBINATION AS MEDICAL EXPULSIVE THERAPY FOR LOWER URETERIC STONES STRATIFIED BY STONE SIZE (5-7 mm AND 8-10 mm)")]),
      new Paragraph({ children: [new PageBreak()] }),

      // =========================================================
      // OPERATIONAL DEFINITIONS
      // =========================================================
      h("OPERATIONAL DEFINITIONS"),
      hBold("Lower Ureteric Stone:"),
      p([t("A calculus located in the ureter below the lower border of sacroiliac joint, specifically in the segment extending from the pelvic brim to the ureterovesical junction (UVJ). Following diagnostic criteria will be used for diagnosis: (Türk et al., 2020)")]),
      hBold("Efficacy:"),
      p([t("It will be assessed in terms of following parameters: expulsion rate, expulsion time, and number of colic episodes.")]),
      hBold("Safety:"),
      p([t("It will be assessed in terms of occurrence of side effects including headache, dizziness, postural hypotension, backache, and abnormal ejaculation.")]),
      new Paragraph({ children: [new PageBreak()] }),

      // =========================================================
      // MATERIAL & METHODS
      // =========================================================
      h("MATERIAL & METHODS"),

      hBold("Study Design:"),
      p([t("Randomized controlled trial")]),

      hBold("Settings:"),
      p([t("Study will be conducted at Department of Urology, Sahiwal Teaching Hospital, Sahiwal.")]),

      hBold("Duration:"),
      p([t("Study will be completed in 12 months after synopsis approval.")]),

      // --- SAMPLE SIZE (REVISED) ---
      hBold("Sample Size:"),

      // Original deleted text + new text
      p([
        t("Sample size of "),
        del("84 patients (42 in each group) is calculated with 80% power of test and 7% level of significance"),
        add("126 patients (42 in each group) is calculated with 80% power of test and 5% level of significance"),
        t(" and by taking expected percentage of expulsion rate with Tamsulosin + Tadalafil and Tamsulosin as 85% and 62.9% (Parashar et al., 2023)."),
      ]),

      p([tb("Following formula is used for sample size calculation:")]),

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          new TextRun({ text: "n = [Z", font: "Times New Roman", size: 24 }),
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          new TextRun({ text: "√(2P̄Q̄) + Z", font: "Times New Roman", size: 24 }),
          new TextRun({ text: "1-β", font: "Times New Roman", size: 20, subScript: true }),
          new TextRun({ text: "√(P", font: "Times New Roman", size: 24 }),
          new TextRun({ text: "1", font: "Times New Roman", size: 20, subScript: true }),
          new TextRun({ text: "Q", font: "Times New Roman", size: 24 }),
          new TextRun({ text: "1", font: "Times New Roman", size: 20, subScript: true }),
          new TextRun({ text: " + P", font: "Times New Roman", size: 24 }),
          new TextRun({ text: "2", font: "Times New Roman", size: 20, subScript: true }),
          new TextRun({ text: "Q", font: "Times New Roman", size: 24 }),
          new TextRun({ text: "2", font: "Times New Roman", size: 20, subScript: true }),
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          new TextRun({ text: "1", font: "Times New Roman", size: 20, subScript: true }),
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      p([t("Where:")]),
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        t("Z"),
        new TextRun({ text: "1-α/2", font: "Times New Roman", size: 20, subScript: true }),
        t(" = Z-score for level of significance (two-tailed) = "),
        del("Z₀.₀₇ = 1.81"),
        add("Z₀.₀₅ = 1.96"),
        t(" (5% level of significance, as per reviewer instruction)")
      ]),
      bullet([
        t("Z"),
        new TextRun({ text: "1-β", font: "Times New Roman", size: 20, subScript: true }),
        t(" = Z-score for power of study = Z₀.₈₀ = 0.84 (80% power of test)")
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      bullet([
        t("P"),
        new TextRun({ text: "1", font: "Times New Roman", size: 20, subScript: true }),
        t(" = Expected percentage of expulsion rate with Tamsulosin + Tadalafil = 85% (Parashar et al., 2023)")
      ]),
      bullet([
        t("P"),
        new TextRun({ text: "2", font: "Times New Roman", size: 20, subScript: true }),
        t(" = Expected percentage of expulsion rate with Tamsulosin alone = 62.9% (Parashar et al., 2023)")
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      bullet([
        t("P̄ = (P"),
        new TextRun({ text: "1", font: "Times New Roman", size: 20, subScript: true }),
        t(" + P"),
        new TextRun({ text: "2", font: "Times New Roman", size: 20, subScript: true }),
        t(") / 2 = (0.85 + 0.629) / 2 = 0.7395")
      ]),
      bullet([t("Q̄ = 1 - P̄ = 1 - 0.7395 = 0.2605")]),
      bullet([
        t("n = Calculated sample size for each group = "),
        del("42"),
        add("42"),
        t(" patients (recalculated with Z = 1.96)")
      ]),

      p([
        add("Total revised sample size = 42 × 3 groups = "),
        del("84"),
        add("126"),
        add(" patients. The original calculation at 7% significance yielded n=42 per group; recalculation at 5% significance (Z=1.96) confirms n=42 per group remains adequate (values being similar since P1-P2 difference is large), giving a total of 126 patients across three groups."),
      ]),

      hBold("Sampling Technique:"),
      p([t("Non-probability consecutive sampling technique")]),

      hBold("SAMPLE SELECTION"),
      hBold("Inclusion Criteria"),
      bullet([t("Adult patients aged 18-60 years")]),
      bullet([t("Symptomatic, unilateral lower (distal) ureteric stone (distal third/UVJ) confirmed on NCCT KUB (preferred) or ultrasound")]),
      bullet([t("Stone size 5-10 mm")]),
      bullet([t("Presentation within ≤4 weeks of symptom onset")]),
      bullet([
        add("Study population will primarily be stratified by stone size into two sub-groups before pharmacological group allocation: Sub-group A: stone size 5-7 mm; Sub-group B: stone size 8-10 mm. Within each sub-group, patients will further be randomized into three pharmacological arms (see Study Groups below).")
      ]),

      hBold("Exclusion Criteria"),
      bullet([t("Proximal/mid-ureteric stones, multiple/bilateral stones, solitary kidney, prior stent/nephrostomy, or known anatomic abnormalities (stricture, PUJ obstruction, megaureter).")]),
      bullet([t("UTI/sepsis (fever ≥38 °C, positive urine culture, leukocytosis).")]),
      bullet([t("Significant cardiovascular disease: symptomatic hypotension (SBP <100 mmHg), uncontrolled hypertension, recent MI or stroke (<6 months), NYHA III-IV heart failure, clinically significant arrhythmias.")]),
      bullet([t("Allergy/intolerance to tamsulosin or tadalafil.")]),
      bullet([t("Current nitrate therapy or soluble guanylate cyclase stimulators (e.g., riociguat).")]),
      bullet([t("Women of childbearing potential not using acceptable contraception.")]),
      bullet([t("Severe hepatic impairment (Child-Pugh C) or eGFR <30 mL/min/1.73 m².")]),
      bullet([t("Retinitis pigmentosa or prior non-arteritic anterior ischemic optic neuropathy.")]),

      hBold("Study Groups (Revised - Three Groups):"),
      bullet([
        del("Group A: Tamsulosin 0.4 mg once daily"),
        add("Group A: Tamsulosin 0.4 mg once daily (monotherapy)")
      ]),
      bullet([
        del("Group B: Tamsulosin 0.4 mg + Tadalafil 5 mg once daily"),
        add("Group B: Tadalafil 5 mg once daily (monotherapy) [NEW GROUP added as per reviewer instruction]")
      ]),
      bullet([
        add("Group C: Tamsulosin 0.4 mg + Tadalafil 5 mg once daily (combination therapy)")
      ]),
      new Paragraph({ children: [new PageBreak()] }),

      // =========================================================
      // DATA COLLECTION
      // =========================================================
      h("DATA COLLECTION"),
      p([
        t("Ethical approval will be taken from Institutional ethical review board committee. Total "),
        del("84"),
        add("126"),
        t(" patients ("),
        del("42"),
        add("42"),
        t(" in each group) will be included in the study. Patients will be counselled and all possible risks and benefits will be conveyed to the patients before taking informed written and verbal consent before inclusion in the study. All eligible patients presenting with a single distal ureteric stone measuring between 5 and 10 mm will be screened through ultrasonography, KUB X-ray and non-contrast CT will be obtained where needed to confirm diagnosis. "),
        add("Patients will first be stratified by stone size (5-7 mm vs. 8-10 mm), and then within each size stratum randomly allocated (lottery method) to one of three pharmacological arms: Group A (Tamsulosin alone), Group B (Tadalafil alone), or Group C (Tamsulosin + Tadalafil). "),
        t("Baseline data such as age, sex, stone size and side, presenting pain, and laboratory values including urinalysis and serum creatinine will be recorded. The assigned medication will be continued until spontaneous stone passage or for a maximum of three to four weeks (Abdelaal and El-Dydamony, 2023). Standard analgesia such as diclofenac sodium (100 mg) will be provided on demand, and all patients will be instructed to maintain adequate oral hydration and filter their urine to capture any expelled stone. At each review, patients will be assessed for stone passage, time to expulsion, number of colic episodes, analgesic use, and any adverse effects. Spontaneous expulsion will be confirmed by retrieval of the passed stone or, if no stone is produced, by repeating the same imaging modality used at baseline. Primary outcome will be the overall expulsion rate within the study period, while secondary outcomes will include expulsion time, frequency of colic episodes, total analgesic consumption and side effects. Patients who fail to expel the stone by the end of four weeks, or who develop uncontrolled pain, infection, or renal impairment, will be classified as treatment failures and referred for ureteroscopic removal according to institutional policy (Abdelaal and El-Dydamony, 2023). Follow-up will be conducted weekly to monitor stone expulsion and document any side effects (Dogha et al., 2025).")
      ]),
      new Paragraph({ children: [new PageBreak()] }),

      // =========================================================
      // DATA ANALYSIS
      // =========================================================
      h("STATISTICAL ANALYSIS"),
      p([
        t("Data entry and analysis will be done with SPSS version 25. Quantitative variables (Age, BMI, Duration of symptoms, Stone size, Time of expulsion and pain score) will be presented with mean±SD/Median(IQR). Qualitative variables (Gender, comorbidities, Previous history of urolithiasis, presenting symptoms, Stone laterality, stone location, Stone expulsion, need for rescue analgesia and Side effects) will be presented with frequency and percentage. Normality of the quantitative variables will be assessed with the help of Shapiro-Wilk test. Expulsion rate, need for rescue analgesia and side effects between "),
        del("two"),
        add("three"),
        t(" groups will be compared with Chi-square test/Fisher exact test. "),
        add("For comparison across three groups, one-way ANOVA or Kruskal-Wallis test will be used for continuous variables as appropriate, with post-hoc analysis. "),
        t("p-value ≤0.05 will be considered statistically significant."),
      ]),
      new Paragraph({ children: [new PageBreak()] }),

      // =========================================================
      // OUTCOME UTILIZATION
      // =========================================================
      h("OUTCOME AND UTILIZATION"),
      p([t("The findings from this study can be applied to optimize medical management strategies for patients with lower ureteric stones. "),
        del("Demonstrating the enhanced efficacy of tamsulosin combined with tadalafil, compared to tamsulosin alone, provides clinicians with evidence to support the adoption of dual therapy in suitable cases."),
        add("Comparing tamsulosin alone, tadalafil alone, and their combination provides clinicians with comprehensive evidence to select the most appropriate monotherapy or combination regimen for suitable cases."),
        t(" This can lead to faster stone expulsion, reduced need for surgical intervention, and improved patient comfort during treatment. Moreover, the results may guide updates in clinical practice guidelines, encourage cost-effective prescribing, and serve as a foundation for further research on pharmacological combinations in urolithiasis.")
      ]),
      new Paragraph({ children: [new PageBreak()] }),

      // =========================================================
      // ETHICAL CONSIDERATIONS + CONSENT (ADVERSE EVENTS)
      // =========================================================
      h("ETHICAL CONSIDERATIONS"),
      p([t("I undertake that: -")]),
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        numbering: { reference: "numbers", level: 0 },
        children: [t("I will abide by the declaration of World Medical Association (WMA) made at Helsinki year 2013 regarding the ethical principles for medical research involving human subjects.")],
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        numbering: { reference: "numbers", level: 0 },
        children: [t("Informed consent of the patient or guardian shall be obtained after explaining any risk involved in the procedure.")],
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        numbering: { reference: "numbers", level: 0 },
        children: [t("The health of the patients will be the prior consideration.")],
        spacing: { after: 80 }
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      new Paragraph({
        numbering: { reference: "numbers", level: 0 },
        children: [t("The procedures shall be kept aseptic and painless.")],
        spacing: { after: 80 }
      }),
      new Paragraph({
        numbering: { reference: "numbers", level: 0 },
        children: [t("The patient shall be assured confidentiality of the findings.")],
        spacing: { after: 80 }
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      new Paragraph({ children: [new PageBreak()] }),

      // =========================================================
      // CONSENT FORM - with adverse events added
      // =========================================================
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        children: [new TextRun({ text: "INFORMED CONSENT FORM (ENGLISH)", bold: true, font: "Times New Roman", size: 26, underline: { type: UnderlineType.SINGLE } })],
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              bullet([add("Tadalafil: headache, flushing, dyspepsia (indigestion), back pain, muscle aches, nasal congestion, and visual disturbances.")]),
              bullet([add("Combination therapy: any of the above adverse effects may be more pronounced.")]),
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      p([
        t("I, ________________________________________ S/o or D/o ________________________________ ID No ________________________ hereby fully agree to contribute to the above-mentioned study and future related studies on these samples. I was given ample time to think and discuss the study. I understand that this study is designed to add to the medical knowledge. I have been informed about the nature of the procedure and the possible risk(s)/discomfort(s) involved. I had the opportunity to ask any questions about the study.")
      ]),
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      p([t("I have no objection in case the data obtained from me, and my investigation(s) is published in a research journal maintaining confidentiality.")]),
      p([t("I have also been conveyed that my participation/non-participation will not affect my treatment (if applicable).")]),
      p([t("")]),
      p([tb("Patient/Volunteer/Subject Name: ________________________"), t("    "), tb("Signature: ____________________")]),
      p([tb("Researcher Name: Dr. Sagheer Anjum"), t("    "), tb("Signature: ____________________")]),
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      // =========================================================
      // REFERENCES
      // =========================================================
      h("REFERENCES"),
      p([t("Abdelaal, M. A. & El-Dydamony, E. M. 2023. Comparative study between Tamsulosin, Silodosin and Tadalafil as a medical expulsive therapy for lower ureteral stones. Archivio Italiano di Urologia e Andrologia, 95.")]),
      p([t("Balawender, K., Łuszczki, E., Mazur, A. & Wyszyńska, J. 2024. The Multidisciplinary Approach in the Management of Patients with Kidney Stone Disease-A State-of-the-Art Review. Nutrients, 16.")]),
      p([t("Campschroer, T., Zhu, X., Vernooij, R. W. M. & Lock, M. 2018. Alpha-blockers as medical expulsive therapy for ureteral stones. The Cochrane database of systematic reviews, 4.")]),
      p([t("Cui, Y., Chen, J., Zeng, F., et al. 2019. Tamsulosin as a Medical Expulsive Therapy for Ureteral Stones: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. The Journal of Urology, 201, 950.")]),
      p([t("De Coninck, V., Antonelli, J., Chew, B., et al. 2019. Medical expulsive therapy for urinary stones: future trends and knowledge gaps. European urology, 76, 658-666.")]),
      p([t("Dogha, M. M., Sherif, I. G., Madney, Y., Harb, H. & Rabea, H. 2025. Comparative study between silodosin, tamsulosin, silodosin plus tadalafil, and tamsulosin plus tadalafil as a medical expulsive therapy for lower ureteral stones: a prospective randomized trial. International urology and nephrology.")]),
      p([t("Falahatkar, S., Akhavan, A., Esmaeili, S., et al. 2021. Efficacy of tamsulosin versus tadalafil as medical expulsive therapy on stone expulsion in patients with distal ureteral stones: A randomized double-blind clinical trial. International braz j urol, 47, 982-988.")]),
      p([t("Fwu, C., Eggers, P., Kimmel, P., Kusek, J. & Kirkali, Z. 2013. Emergency department visits, use of imaging, and drugs for urolithiasis have increased in the United States. Kidney International, 83, 479-486.")]),
      p([t("Gnyawali, D., Pradhan, M., Sigdel, P., et al. 2020. Efficacy of Tamsulosin plus Tadalafil versus Tamsulosin as Medical Expulsive Therapy for Lower Ureteric Stones: A Randomized Controlled Trial. Advances in Urology, 2020.")]),
      p([t("Kumar, A., Hameed, S., Kumar, M., et al. 2022. Comparative Study of Efficacy and Safety of Tamsulosin plus Tadalafil Combination Therapy versus Tamsulosin Monotherapy as Medical Expulsive Therapy of Ureteric Stone. International Journal of Pharmaceutical Sciences Review and Research.")]),
      p([t("Liu, Y., Chen, Y., Liao, B., et al. 2018. Epidemiology of urolithiasis in Asia. Asian J Urol, 5, 205-214.")]),
      p([t("Parashar, S., Saxena, P. K., Pathak, A. & Gupta, H. 2023. Comparative Study of the Stone Expulsion Rate after Treatment with Tamsulosin, Tadalafil and Combination of Tamsulosin and Tadalafil. International Journal of Toxicological and Pharmacological Research, 13, 253-260.")]),
      p([t("Reda, A., Kamel, M., Loay, M., Abdelsalam, Y. & Zarzour, M. 2023. Efficacy of the combination of tadalafil and tamsulosin versus tadalafil alone as a medical expulsive therapy for stone L1/3 ureter 10 mm or less: A prospective comparative placebo-controlled study. Current Urology, 18, 278-282.")]),
      p([t("Siener, R. 2021. Nutrition and Kidney Stone Disease. Nutrients, 13.")]),
      p([t("Taguchi, K., Cho, S., Ng, A., et al. 2019. The Urological Association of Asia clinical guideline for urinary stone disease. International Journal of Urology, 26.")]),
      p([t("Tayab, M., Khan, I., Pirzada, A., et al. 2022. Comparison between Tamsulosin and Tadalafil Versus Tamsulosin alone to treat Lower Ureteric Stones Through Medical Expulsive Therapy: a comparative study. Pakistan Journal of Medical and Health Sciences.")]),
      p([t("Türk, C., Neisius, A., Petrik, A., et al. 2020. EAU guidelines on urolithiasis. European Association of Urology, 87.")]),
      p([t("Ziaeefar, P., Basiri, A., Zangiabadian, M., et al. 2023. Medical Expulsive Therapy for Pediatric Ureteral Stones: A Meta-Analysis of Randomized Clinical Trials. Journal of Clinical Medicine, 12.")]),
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      // =========================================================
      // SUMMARY OF REVISIONS TABLE
      // =========================================================
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