Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 40 to 80

Using Tadalafil to Improve Urinary and Sexual Function After Prostate Surgery

Official title: 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)

Run by Mansoura University · NCT05955001 · Data updated 2026-11-12

This study is testing if Tadalafil can help men over 40 improve their urinary and sexual function after having prostate surgery for an enlarged prostate.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages40 Years to 80 Years
SexAll
Enrollment110 (estimated)
SponsorMansoura University
Academic / other
Locations1 site (Al Mansurah, Dakahlia Governorate)
StatusRecruiting
StartedApril 1, 2023
Main results expectedJuly 2025
Study endsJuly 2025
Registry record updatedJune 11, 2025
Trial IDNCT05955001 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are sexually active men aged 40 and older with lower urinary tract symptoms due to BPH who have failed previous medical treatments.

Probably not a fit

Patients who are sexually inactive or have severe comorbid conditions such as uncontrolled diabetes or significant renal insufficiency may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of Tadalafil, a medication commonly used for erectile dysfunction, in improving lower urinary tract symptoms and erectile function in men who have undergone endoscopic enucleation of the prostate due to benign prostatic hyperplasia (BPH). The study hypothesizes that Tadalafil may alleviate storage symptoms and enhance recovery of erectile function post-surgery. It is a randomized controlled trial comparing Tadalafil to a placebo, focusing on sexually active men aged 40 and older who have not responded to previous medical treatments for BPH. The trial aims to provide insights into the relationship between urinary symptoms and erectile dysfunction following prostate surgery.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for men suffering from erectile dysfunction and urinary symptoms after prostate surgery.

How similar studies have gone: Previous studies have shown mixed results regarding the improvement of erectile function and urinary symptoms after prostate surgery, indicating that this approach may provide new insights but is not entirely novel.

Who can join: the full rules

Show full inclusion / exclusion 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)

Where it's running

  • Urology and Nephrology Center
    Al Mansurah, Dakahlia Governorate, Egypt
    Recruiting

Study contacts

  • Principal investigator: Mahmoud Laymon, MD,MRCS — urology and nephrology center mansoura university
  • Study coordinator: Mahmoud Laymon, MD,MRCS
  • Email: dr_mahmoudlaymon@mans.edu.eg
  • Phone: 01002275698

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.