Actively Recruiting

Phase 2
Phase 3
Age: 40Years - 80Years
All Genders
NCT05955001

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

Led by Mansoura University · Updated on 2025-06-11

110

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 40 years or older
  • Diagnosed with lower urinary tract symptoms secondary to bladder outlet obstruction caused by benign prostatic hyperplasia that did not improve with medical treatment
  • International prostate symptom score (IPSS) greater than 15 with a bother score (quality of life) of 3 or higher
  • Peak urinary flow rate (Qmax) less than 15 ml/sec
  • American Society of Anesthesiologists (ASA) score of 3 or less
  • Sexually active men not currently using phosphodiesterase type 5 inhibitors (PDE5I)
Not Eligible

You will not qualify if you...

  • Use of nitrates, potassium channel openers, or alpha-1 blockers like doxazosin and terazosin for hypertension
  • History of unstable angina, recent heart attack, stroke, or heart failure
  • Severe liver or kidney failure
  • Sexual inactivity
  • Uncontrolled diabetes or neurological conditions such as Parkinson's disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, Egypt, 35516

Actively Recruiting

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Research Team

M

Mahmoud Laymon, MD,MRCS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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