Efficacy of Tadalafil (5mg) For Treatment of Early Storage Symptoms and Erectile Dysfunction After Endoscopic Enucleation of Prostate
Recruiting
Phase 2
Phase 3
Interventional Study
Erectile Dysfunction
Lower Urinary Tract Symptoms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 – 80
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 110 (estimated)
- Sponsor
- Mansoura University · Other
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About This Trial
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, desc…
Trial Locations
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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 anaest…
Contacts