Recruiting PHASE2, PHASE3 Erectile Dysfunction

Tests treatment safety and results for Erectile Dysfunction

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

ClinicalTrials.gov ID: NCT05955001

What this study is testing

What it's testing
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.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 40 to 80

You may be able to join 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.

You likely can't join 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)
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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)

The study team makes the final eligibility decision.

Where it's taking place

  • Al Mansurah, Dakahlia Governorate, Egypt

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Al Mansurah, Dakahlia Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.