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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Urology and Nephrology Center
RECRUITING
Al Mansurah
Contact Information
Primary
Mahmoud Laymon, MD,MRCS
dr_mahmoudlaymon@mans.edu.eg
01002275698
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-07
Participants
Target number of participants: 110
Treatments
Experimental: Tadalafil 5 mg daily
those patients will receive Tadalafil 5 mg daily after HoLEP
Experimental: Placebo
Those patients will receive Placebo after HoLEP
Related Therapeutic Areas
Sponsors
Leads: Mansoura University

This content was sourced from clinicaltrials.gov