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

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.

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Key information

Conditions

BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score

Time frame: 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 outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Adel Kurkar Abdallah, Prof Dr

CONTACT

[email protected]

+201098197880

Ali adel Mansour Hageb, GP

CONTACT

[email protected]

+201109049717 ext. +967781118703

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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"

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Mar 12, 2026
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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