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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction, Lower Urinary Tract Symptoms

In brief

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.

Key facts

Study ID

NCT05955001

Run by

Mansoura University

People needed

110

Starts

2023-04-01

Expected to finish

2025-07-01

Last updated by the study team

2025-06-11

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Urology and Nephrology Center — Al Mansurah, Dakahlia Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.