NCT05955001 Efficacy of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Endoscopic Enucleation of Prostate
| NCT ID | NCT05955001 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Mansoura University |
| Condition | Erectile Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2023-04-01 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Mahmoud Laymon, MD,MRCS
PRINCIPAL INVESTIGATOR
urology and nephrology center mansoura university
Frequently Asked Questions
Who can join the NCT05955001 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Erectile Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05955001 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05955001 currently recruiting?
Yes, NCT05955001 is actively recruiting participants. Contact the research team at dr_mahmoudlaymon@mans.edu.eg for enrollment information.
Where is the NCT05955001 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT05955001 clinical trial?
NCT05955001 is sponsored by Mansoura University. The principal investigator is Mahmoud Laymon, MD,MRCS at urology and nephrology center mansoura university. The trial plans to enroll 110 participants.