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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorAssiut University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Tadalafil 5mg (Male)

    Drug

    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.

  • Omiga 3

    Drug

    Giving omiga 3 for patients who are not in tadalafil group

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Daily tadalafil 5 mg userActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 weeks

Secondary outcomes

1

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

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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