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NCT05955001
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)
Phase 2/Phase 3 trial testing Tadalafil 5mg / Placebo in Erectile Dysfunction in 110 participants. Currently enrolling.
1 July 2025
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 110 |
| Start date | 1 April 2023 |
| Primary completion | 1 July 2025 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Tadalafil 5mg / Placebo — full drug profile →
Conditions studied
- Erectile Dysfunction — all drugs for Erectile Dysfunction →
- Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →
Sponsor
Mansoura University
Who can join
Adults 40 to 80, any sex, with Erectile Dysfunction or Lower Urinary Tract Symptoms. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Orgasm perception domain of International Index of Erectile Function (IIEF-15) questionnaire at 6 months among the study groups
Time frame: 1 and 3 months postoperatively (during treatment), and at 6 months postoperatively (3 months after treatment cessation)
the erectile function will be assessed using a validated questionnaire and compared to baseline .
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05955001
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05955001 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University
- Last refreshed: 6 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05955001.
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