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Recruiting Phase 2, Phase 3 NCT05955001

Efficacy of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Endoscopic Enucleation of Prostate

Trial Parameters

Condition Erectile Dysfunction
Sponsor Mansoura University
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 110
Sex ALL
Min Age 40 Years
Max Age 80 Years
Start Date 2023-04-01
Completion 2025-07
Interventions
Tadalafil 5mg / Placebo

Brief Summary

From previous studies, the investigators found that sexual outcomes after prostate surgery may show insignificant improvement, remain unchanged or deteriorate in non-negligible number of patients especially those with high preoperative IIEF scores. Deterioration of erectile function could be attributed to persistence of storage symptoms specially nocturia. Several pathophysiologic mechanisms, described before, are involved in pathogenesis of LUTS and ED and one can imagine that after relief of obstruction, the erectile function should improve, however lack of improvement or even deterioration suggests that damage associated with these mechanisms is irreversible and patients may require some sort of penile rehabilitation after surgery. The investigators hypothesized that Tadalafil may enhance relief of storage symptoms and enhance recovery of erectile function after surgery for BPH. With this assumption, a RCT was designed to examine the utility and efficacy of Tadalafil, once daily dose, to relieve persistent/ de novo storage symptoms and early erectile function deterioration after endoscopic prostate surgery.

Eligibility Criteria

Inclusion Criteria: * Patients' age ≥ 40 years * LUTS secondary to BOO due to BPH who failed medical treatment * International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8) * Peak urinary flow rate (Qmax) \<15 ml/sec. * ASA (American society of anaesthesiologists) score ≤ 3. * Sexually active men, not receiving PDE5I Exclusion Criteria: * Patients using nitrates, potassium channel opener, or α1-blockers doxazosin and terazosin for control of hypertension * Patients with unstable angina pectoris, recent myocardial infarction or stroke myocardial insufficiency. * Patients with severe hepatic or renal insufficiency. * Patients who are sexually inactive. * Patients with uncontrolled diabetes mellitus or neurologic condition(eg. parkinsoism)

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