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

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 11, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Nov 2024 to Jul 2025 Completion date: May 2025 to Jul 2025 · Secondary endpoints: details revised at 1 of 1 entry · Study description expanded, about 78 wordsv3 Show 3 more changesShow less
    • Completion date: May 2025 to Jul 2025
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 78 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Active, Not Recruiting to Recruiting Primary completion date: May 1, 2024 to Nov 2024 · Completion date: May 1, 2025 to May 2025 · Interventions: Tadalafil 5mg (Drug) to Tadalafil 5mg / Placebo (Drug) · 1 morev2 Show 4 more changesShow less
    • Primary completion date: May 1, 2024 to Nov 2024
    • Completion date: May 1, 2025 to May 2025
    • Interventions: Tadalafil 5mg (Drug) to Tadalafil 5mg / Placebo (Drug)
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05955001
Lead Sponsor Mansoura University
Conditions Erectile Dysfunction, Lower Urinary Tract Symptoms
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov