About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Tadalafil 5mg (Male)
DrugTadalafil 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.
Omiga 3
DrugGiving omiga 3 for patients who are not in tadalafil group
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score
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 outcomes
Change from baseline in IPSS storage subdomain score at 4 weeks , 8weeks , and 12 weeks. Time to micturate freely IPSS total .
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: