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

NCT07466030 | Not Yet Recruiting Phase 1

• 1 other identifier: Tadalafil 5mg post AEEP
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

Storage LUTS post AEEP

Outcome Measures

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

  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 .

  12 weeks

Study Arms (2)

Daily tadalafil 5 mg user

ACTIVE COMPARATOR

Patients will have daily tadalafil 5 mg for 3 months post AEEP

Drug: Tadalafil 5mg (Male)

Placebo

PLACEBO COMPARATOR

Omiga 3 for patient

Drug: Omiga 3

Interventions

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.

Daily tadalafil 5 mg user

Omiga 3 DRUG

Giving omiga 3 for patients who are not in tadalafil group

Placebo

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Pang KH, Ortner G, Yuan Y, Biyani CS, Tokas T. Complications and functional outcomes of endoscopic enucleation of the prostate: a systematic review and meta-analysis of randomized-controlled studies. Cent European J Urol \[Internet\]. 2022 \[cited 2026 Jan
• Vo LT, Armany D, Chalasani V, Bariol S V., Baskaranathan S, Hossack T, et al. Endoscopic enucleation of the prostate versus transurethral resection of the prostate for benign prostatic hyperplasia: a systematic review and meta-analysis. Prostate Cancer P
• 4\. Kim TH, Song PH. Anatomical endoscopic enucleation of the prostate for bladder outlet obstruction: a narrative review. Journal of Yeungnam Medical Science \[Internet\]. 2021 Jan 1 \[cited 2026 Jan 3\];39(1):12-7.:
• Ma J, Liu Z, Wu J, Zhou Z, Zhang X, Cui Y, et al. Role of application of tadalafil 5 mg once-daily (≥6 months) in men with erectile dysfunction from six randomized controlled trials. Transl Androl Urol \[Internet\]. 2020 Jun 1 \[cited 2026 Jan 3\];9(3):14054
• Yang J, Jian ZY, Wang J, Zhang G. Phosphodiesterase type-5 inhibitors for erectile dysfunction following nerve-sparing radical prostatectomy: A network meta-analysis. Medicine \[Internet\]. 2021 Feb 26 \[cited 2026 Jan 3\];100(8):e23778.
• Goh HJ, Sung JM, Lee KH, Jo JK, Kim KN. Efficacy of phosphodiesterase type 5 inhibitors in patients with erectile dysfunction after nerve-sparing radical prostatectomy: a systematic review and meta-analysis. Transl Androl Urol \[Internet\]. 2022 Feb 1 \[cit
• Kaulback K, Argáez C. Phosphodiesterase Type 5 Inhibitors for Penile Rehabilitation Post Radical Prostatectomy: A Review of Clinical Effectiveness and Guidelines. Phosphodiesterase Type 5 Inhibitors for Penile Rehabilitation Post Radical Prostatectomy: A
• Gadelha GCA, Júnior AM de C. Phosphodiesterase-5 inhibitors for erectile function rehabilitation in patients undergoing nerve sparing radical prostatectomy: a scoping review. Rev Col Bras Cir \[Internet\]. 2024 \[cited 2026 Jan 3\];51:e20243757
• Clavell-Hernández J, Wang R. PDE-5 inhibitors should be used post radical prostatectomy as erection function rehabilitation? Opinion: No. International Brazilian Journal of Urology : official journal of the Brazilian Society of Urology \[Internet\]. 2017 M

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Ali adel Mansour Hageb, GP

CONTACT

+201109049717; Alihajeb42@gmail.com

Adel Kurkar Abdallah, Prof Dr

CONTACT

+201098197880; kurkar1970@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The drug
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share