Actively Recruiting
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)
Led by Mansoura University · Updated on 2025-06-11
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of Tadalafil, a medication, for improving early storage symptoms and erectile dysfunction in men after endoscopic enucleation of the prostate, a surgery for benign prostatic hyperplasia (BPH). BPH causes bothersome lower urinary tract symptoms (LUTS) such as frequent urination, urgency, and nocturia, which can be linked to erectile dysfunction. Despite surgical relief of obstruction, some men experience persistent or worsening symptoms, possibly due to irreversible damage from underlying mechanisms. The study investigates whether Tadalafil can help relieve these symptoms and support erectile function recovery. Participants who have undergone Holmium laser enucleation of the prostate (HoLEP) will be randomly assigned to receive either a daily 5 mg dose of Tadalafil or a placebo for three months. The study compares these two groups to assess the effectiveness of Tadalafil in reducing persistent or new storage symptoms and early decline in erectile function after surgery. The treatment phase lasts three months, followed by an additional three-month follow-up to observe symptom durability and recovery. During the study, participants will complete questionnaires measuring erectile function and prostate symptoms at multiple time points: 2 weeks, 1 month, 3 months (during treatment), and 6 months after surgery. The primary outcome focuses on orgasm perception using the International Index of Erectile Function (IIEF-15). Secondary outcomes include changes in the International Prostate Symptom Score (IPSS), assessing voiding and storage symptoms. Safety and quality of life will be monitored throughout the study period, which spans six months from surgery to final follow-up.
CONDITIONS
Brief Title
Efficacy of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Endoscopic Enucleation of Prostate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 40 years or older
- Men with lower urinary tract symptoms due to bladder outlet obstruction from benign prostatic hyperplasia who did not improve with medical treatment
- International prostate symptom score (IPSS) greater than 15 and quality of life score 3 or higher
- Peak urinary flow rate 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)
You will not qualify if you...
- Use of nitrates, potassium channel openers, or alpha-1 blockers doxazosin and terazosin for hypertension control
- Unstable angina, recent heart attack, stroke, or heart failure
- Severe liver or kidney insufficiency
- Sexually inactive men
- Uncontrolled diabetes mellitus or neurological conditions such as Parkinson's disease
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo Anatomical Endoscopic Enucleation of Prostate (AEEP) including HoLEP surgery for treatment of benign prostatic hyperplasia.
1 surgical visit (in-person)
Duration - 3 months
Participants receive either Tadalafil 5 mg daily or placebo for 3 months after surgery to relieve storage symptoms and support recovery of erectile function.
Regular visits during treatment for assessments at 2 weeks, 1 month, and 3 months
Duration - 3 months
Participants are monitored for symptom durability and recovery after treatment cessation.
1 visit at 6 months postoperatively (3 months after treatment ends)
Trial Site Locations
Total: 1 location
1
Urology and Nephrology Center
Al Mansurah, Dakahlia Governorate, Egypt, 35516
Actively Recruiting
Research Team
M
Mahmoud Laymon, MD,MRCS
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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