Using Tadalafil to Improve Urinary and Sexual Function After Prostate Surgery
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)
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
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT05955001 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Al Mansurah, Dakahlia Governorate
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.