5mg Tadalafil
Group A received early administration of tadalafil 5 mg once daily starting one week after TURP, while Group B (control group) received a placebo. The randomization process was double-blinded, with both patients and surgeons blinded tadalafil 2 5 mg to group allocation.
| Aspect | Details |
|---|---|
| Recommended Dose | 5 mg once daily |
| Timing of Dose | With or without food, same time daily |
| Missed Dose | Take as soon as remembered, do not double dose |
| Duration of Use | As prescribed, typically long-term |
| Overdose | Seek medical attention; symptoms may include headache, dizziness |
The study was conducted and will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The sample size was calculated a priori using power analysis (G*Power, version 3.1.9.2). The analysis was conservatively based on three primary outcomes: resolution of storage symptoms post-TURP, improvement in erectile function, and alleviation of lower urinary tract symptoms (LUTS). Based on these parameters, a minimum sample size of 105 patients per group was estimated to achieve 80% statistical power, accounting for an anticipated dropout rate of 20%.
- Do not take tadalafil 5mg with nitrate medications.
- Alcohol may increase side effects or reduce effectiveness.
- Store at room temperature, away from moisture and heat.
The primary outcome of the study was to evaluate the effect of early administration of tadalafil 5 mg once daily on persistent storage lower urinary tract symptoms (LUTS) and erectile function following transurethral resection of the prostate (TURP).
- Some people may experience nasal congestion or dizziness.
- Use caution when combining with other erectile dysfunction drugs.
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The secondary outcome was to assess patient compliance and any adverse effects associated with tadalafil use. Data analysis was conducted using the Statistical Package for the Social Sciences (SPSS), version 26.
14.1 Tadalafil Tablets for Use as Needed for ED
It also facilitates early recovery of erectile function post-prostatectomy and may help protect against penile structural changes. However, unassisted erectile function does not improve after discontinuation of active therapy for nine months [18]. Tadalafil monotherapy significantly improves both storage and voiding lower urinary tract symptoms (LUTS) and enhances the International Prostate Symptom Score (IPSS) [12]. To determine the potential benefits of initiating tadalafil early after TURP, we conducted this study to evaluate the efficacy of daily tadalafil 5 mg in managing persistent storage symptoms and improving erectile function post-TURP. Following approval by the institutional ethics committee, this study was conducted at a tertiary care hospital between May 2021 and October 2022.
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Patients diagnosed with benign prostatic hyperplasia (BPH) who underwent transurethral resection of the prostate (TURP), either monopolar or bipolar, were eligible for inclusion. Informed consent was obtained from all participants prior to enrollment. Patients were then randomized into two groups: Group A received tadalafil 5 mg once daily, while Group B received a placebo. All patients included in the study were sexually active prior to undergoing TURP. Patients who were sexually inactive were excluded from analyses related to sexual function, due to the recognized limitations of the International Index of Erectile Function (IIEF-5) in evaluating erectile function among sexually inactive men. Categorical variables were summarized using absolute frequencies and compared using the chi-square test or Fisher’s exact test, as appropriate. Quantitative variables were expressed as means and standard deviations for normally distributed data, or as medians and interquartile ranges for non-normally distributed data. Between-group comparisons of quantitative variables were performed using the independent samples t-test for normally distributed data and the Mann–Whitney U test for non-normally distributed data.
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Within-group comparisons over two time points were analyzed using the paired samples t-test for normally distributed data and the Wilcoxon signed-rank test for non-normally distributed data. A p-value of < 0.05 was considered statistically significant, while a p-value of ≤ 0.001 was considered highly significant.
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A comprehensive medical history was obtained for each participant. Evaluations included the IIEF-5 questionnaire for erectile function, the International Prostate Symptom Score (IPSS), and the IPSS storage symptom subscore-15 for assessing storage symptoms. Additional assessments included uroflowmetry, pelvi-abdominal ultrasonography with post-void residual (PVR) urine measurement, and laboratory investigations (urinalysis, urine culture, renal function tests, complete blood count, coagulation profile, and prostate-specific antigen [PSA] level). All evaluations were conducted at baseline (pre-TURP) and at 1, 3, and 6 months postoperatively. Patients were randomly assigned in a 1:1 ratio into two groups using simple randomization. Of the 270 patients assessed for eligibility, 195 were enrolled in the study. These patients were randomized into two groups: 103 patients (53%) were assigned to Group A, receiving tadalafil 5 mg once daily, and 92 patients (47%) to Group B, receiving a placebo.
| Property | Description | Value/Notes |
|---|---|---|
| Active Ingredient | Tadalafil | 5 mg |
| Drug Class | Phosphodiesterase type 5 inhibitor | - |
| Half-life | 17.5 hours | Approximate |
| Bioavailability | ~80% | Oral administration |
| Absorption Time | 2 hours | Peak plasma concentration |
| Metabolism | Liver (via CYP3A4 enzyme) | - |
| Excretion | Feces (~61%), Urine (~36%) | - |
The allocation process is illustrated in the CONSORT flow diagram Fig.1.
Additional information
Our study has been approved by local ethical committee Kafrelsheikh university(MKSU50-3–1) on 20/5/2021 and by clinical trials (NCT06788704) on 25/1/2025. La fonction érectile a été évaluée à l’aide du questionnaire de l’International Index of Erectile Function-5 (IIEF-5), et les LUTS ont été évalués à l’aide de l’International Prostate Symptom Score (IPSS). Men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) have a higher incidence of erectile dysfunction (ED) [1]. Moreover, LUTS themselves serve as an independent risk factor for ED, significantly compromising quality of life (QoL). The underlying pathophysiological mechanisms linking LUTS secondary to BPH and ED remain incompletely understood, although both conditions share several common determinants [9, 16].
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Transurethral resection of the prostate (TURP) remains the gold standard for managing benign prostatic hyperplasia (BPH), despite the introduction of newer minimally invasive surgical techniques [5, 22]. However, the impact of TURP on sexual function remains uncertain. While some studies report a negative effect, others suggest an improvement in sexual function among patients with ED [19, 26]. TURP may contribute to ED through various mechanisms, primarily due to thermal injury affecting the cavernous nerves during surgery. Additional factors include the psychological impact of the procedure and the temporary cessation of sexual activity in the postoperative period [24]. There is a statistically non-significant difference between the studied groups regarding age, BMI, medical comorbidities and prostate size Table 1. With regard to erectile function, there was no statistically significant difference in baseline IIEF-5 scores between the two groups (p = 0.131). In Group A, a significant improvement in IIEF-5 scores was observed following TURP.
Side Effects
The study was conducted at a tertiary care hospital between May 2021 and October 2022. A total of 195 patients were enrolled and randomized into two groups: Group A (n = 103), which received tadalafil 5 mg once daily, and Group B (n = 92), which received a placebo. The mean ± standard deviation (SD) scores for the International Index of Erectile Function (IIEF-5) in Group A at 1, 3, and 6 months post-TURP were 11.59 ± 1.90, 19.80 ± 1.12, and 20.97 ± 0.72, respectively. In Group B, the corresponding scores were 4.88 ± 0.82, 12.86 ± 1.56, and 15.32 ± 1.28. These differences were statistically significant (P < 0.001).
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Similarly, the mean ± SD values for the International Prostate Symptom Score (IPSS) in Group A at 1, 3, and 6 months post-TURP were 7.31 ± 1.66, 4.46 ± 0.97, and 2.33 ± 0.69, respectively, compared to 9.62 ± 3.34, 5.40 ± 1.98, and 2.83 ± 1.27 in Group B (P < 0.001). Regarding storage symptom subscores, Group A demonstrated preoperative and postoperative mean ± SD values of 8.63 ± 1.82, 3.05 ± 0.78, 1.63 ± 0.49, and 0.92 ± 0.67 at preoperative, 1, 3, and 6 months, respectively. In contrast, Group B showed corresponding values of 3.22 ± 0.72, 2.48 ± 0.50, and 1.69 ± 0.47. These differences were also statistically significant (P < 0.001). Tadalafil 5 mg daily as monotherapy following TURP can lead to early improvement in erectile function; however, its effect on persistent storage lower urinary tract symptoms (LUTS) post-TURP appears to be modest. The mean ± SD IIEF-5 score in Group A was 9.84 ± 2.6 at baseline, which increased to 11.59 ± 1.9, 19.8 ± 1.12, and 20.97 ± 0.72 at 1, 3, and 6 months postoperatively, respectively (P < 0.001), as shown in Fig.2.
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Previous studies have reported that some patients experience persistent irritative symptoms following TURP, requiring postoperative medication to manage ongoing urinary symptoms. These symptoms significantly impact patients'quality of life after surgery. When selecting candidates for TURP, predicting the persistence of irritative bladder symptoms is crucial; however, studies investigating prognostic factors for bladder irritation remain limited. According to recent research, severe preoperative irritative bladder symptoms or frequent nocturia may increase the likelihood of persistent postoperative symptoms [11]. Phosphodiesterase type 5 inhibitors (PDE5-Is) were initially approved for the treatment of ED; however, they have also been shown to be highly effective in alleviating LUTS in men, regardless of the presence of ED [3, 17, 20, 23].
Authors’ contributions
PDE5-Is promote relaxation of the bladder neck and prostate by increasing nitric oxide levels in smooth muscle, thereby directly influencing micturition phases in addition to their role in penile erection erectile dysfunction pills tadalafil [6, 7]. Another study indicates that a once-daily dose of 5 mg tadalafil is a potentially effective, well-tolerated, and safe treatment option for patients with LUTS [4]. Tadalafil 5 mg once daily is currently approved for the treatment of LUTS, regardless of the presence of coexisting ED [16]. Another study reported that Tadalafil 5 mg once daily improved LUTS in men without ED by a magnitude like that observed in men with ED [2]. Once-daily tadalafil 5 mg has been shown to be most effective in enhancing drug-assisted erectile function in men with ED following radical prostatectomy. In contrast, Group B showed a significant decline in erectile function at 1 month post-TURP, with the IIEF-5 score decreasing from a baseline of 10.43 ± 2.81 to 4.88 ± 0.82.
| Indication | Purpose | Approved By FDA | Additional Notes |
|---|---|---|---|
| Erectile Dysfunction | Improve penile blood flow | Yes | Taken once daily |
| Benign Prostatic Hyperplasia | Relieve urinary symptoms | Yes | Off-label, consult doctor |
| Pulmonary Hypertension | Vasodilation in lungs | Off-label | Not typical for 5mg dose |
| Prevention of Altitude Sickness | Improve blood flow at high altitudes | No | Experimental use |
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