RecruitingPhase 2Phase 3NCT05955001

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

A Randomized Controlled Trial to Examine the Utility of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Anatomical Endoscopic Enucleation of Prostate (AEEP)


Sponsor

Mansoura University

Enrollment

110 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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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Interventions

DRUGTadalafil 5mg / Placebo

Patients after Holmium laser Enucleation of Prostate (HoLEP) will receive single daily dose of Tadalafil for 3 months and compared to Placebo


Locations(1)

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, Egypt

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NCT05955001


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