Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate

Impact of Daily Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate :A Randomized , Single Blinded ,Controlled Trial"

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07466030

Enrollment

Registered

2026-03-12

Start date

2026-03-01

Completion date

2028-09-01

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

Storage LUTS post AEEP

Brief summary

The aim of this study is to evaluate the impact of daily tadalafil 5 mg on storage lower urinary tract symptoms (LUTS) during the early postoperative period following Anatomical endoscopic enucleation of prostate in a randomized controlled clinical trial.

Interventions

DRUGTadalafil 5mg (Male)

Tadalafil 5 mg is a phosphodiesterase type 5 (PDE-5) inhibitor taken orally, commonly prescribed as a once-daily low dose therapy. It works by relaxing smooth muscle and improving blood flow in specific tissues.

DRUGOmiga 3

Giving omiga 3 for patients who are not in tadalafil group

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

The drug

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* Must be able to swallow tablets * Adult males undergoing elective AEEP for symptomatic benign prostatic hyperplasia (BPH) with prostate volume ≥40 ml , Moderate to severe LUTS defined by International Prostate Symptom Score (IPSS) ≥19 at baseline. * Patient is Willing to participate and able to provide written informed consent

Exclusion criteria

* Contraindications to tadalafil (e.g., nitrate use, severe hepatic/renal impairment, uncontrolled hypotension) , neurogenic bladder. , Preoperative urinary catheter dependence , post-void residual urine \>350 ml. ,, Cognitive impairment precluding questionnaire completion

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score	12 weeks	More Precise Academic Wording: * Proportion of patients: The percentage (%) of the total study population. * Stress urinary incontinence (SUI): Involuntary leakage of urine during activities that increase intra-abdominal pressure (e.g., coughing, sneezing, lifting). * 12 weeks post-operative: Three months after surgery. * Assessed by IPSS score: Evaluation based on patient responses to the International Prostate Symptom Score questionnaire. Important Methodological Note: The International Prostate Symptom Score (IPSS) is primarily designed to assess lower urinary tract symptoms (LUTS) such as: * Frequency * Urgency * Weak stream * Nocturia

Secondary

Measure	Time frame
Change from baseline in IPSS storage subdomain score at 4 weeks , 8weeks , and 12 weeks. Time to micturate freely IPSS total .	12 weeks

Contacts

CONTACTAli adel Mansour Hageb, GP

Alihajeb42@gmail.com+201109049717

CONTACTAdel Kurkar Abdallah, Prof Dr

kurkar1970@gmail.com+201098197880

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026