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Not yet recruiting NCT07466030

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

Phase I Interventional BPH (Benign Prostatic Hyperplasia)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tadalafil 5mg (Male), Omiga 3.
Who it may be relevant to
Registry conditions: BPH (Benign Prostatic Hyperplasia). Basic parameters: No limits · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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"

Overview

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

  • Drug Tadalafil 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.
  • Drug Omiga 3
    Giving omiga 3 for patients who are not in tadalafil group

Primary outcome measures

  • Proportion of patients achieving stress urine incontinence at 12 weeks post op, assessed by IPSS score [Time frame: 12 weeks]
Secondary outcome measures (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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07466030 · Tadalafil 5mg post AEEP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗