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NCT Number: NCT06491108

Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS.

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Key information

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Faculity of medicine - Tanta university

Tanta, Gharbia Governorate, 31528, Egypt

Location status: Recruiting

Location contact

Ahmed R. Abouramadan, MD

CONTACT

[email protected]

01001424064

Hazem B. Baz, M.B.B.Ch

PRINCIPAL_INVESTIGATOR

Mohamed G. Soliman, MD

CONTACT

[email protected]

01018362537

Mohamed G. Soliman, MD

PRINCIPAL_INVESTIGATOR

About this study

This is prospective randomized controlled study that will be conducted on men with BPH related LUTS amenable to medical treatment at Urology Department, Faculty of Medicine, Tanta University - Egypt after having their written informed consent.

The study is planned to include 150 patients in the study period from April 2024 to April 2025. Each enrolled patient must complete 12 weeks on medication with strict scheduled follow up.

Inclusion criteria

Sexually active patients with moderate BPH related LUTS amenable to medical treatment and completed 12 weeks follow up period.

Exclusion criteria

Indication for combined therapy in patients who have moderate to severe LUTS and an increased risk of disease progression (e.g. prostate volume more than 40 ml) or patients in need for anti-muscarinic for predominant storage symptoms.

Indication for surgical intervention:

Medically complicated patients:

Cardiac patients, unstable angina, recent myocardial infarction (<3months), hypotension.

Concomitant uses (potassium channel openers, alpha 1 blockers, nitrates). Stroke since less than 6 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sexually active patients .
  • ModerateBPH related LUTS ( bengin prostatic hyperplasia related lower urinary tract symtoms ) i.e: (international prostatic symptom score 8 to 19 : the higher score is the worse symptoms ).
  • Patients accepted medical treatment and completed 12 weeks on medical treatment and strict follow up .

Exclusion criteria

  • Indication for combined therapy as prostate size over 40 gm .
  • Gross hematuria.
  • Refractory urine retention .
  • Bilateral hydro-ureteronephrosis or renal insufficiency secondary to bengin prostatic hyperplasia.
  • Bladder diverticula or calculi .
  • History of bladder or prostate cancer.
  • Unwilling patients to medical therapy.
  • History of pelvic surgery or urethral stricture.

Treatment and study plan

Vardenafil 5 Mg Oral Tablet

Drug

Comparing safety and efficacy of Vardenafil 5 mg twice oral daily versus established drugs e.g.Tadalafil 5mg and Tamsulosin 0.4 mg once oral daily in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS (benign prostatic hyperplasia related lower urinary tract syptoms )

Other names: Vardenafil 5 mg

Primary outcomes

  1. International prostate symptom score (IPSS total score)

    Time frame: 3 months

    Change in pre and post treatment condition (IPSS : international prostate symptom score - decresing in the score equals improving the symptoms )

  2. The maximum urinary flow rate (Q-max)

    Time frame: 3 months

    Change in pre and post treatment condition (increasing at Q-max equals improving the symptoms )

Secondary outcomes

  1. Sexual Health Inventory for Men (SHIM)

    Time frame: 3 months

    Change in pre and post treatment condition (SHIM: Sexual Health Inventory for Men - increasing in the score equals improving the symptoms )

Study contacts

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

Hazem B. Baz, M.B.B.Ch

CONTACT

[email protected]

00201020337967

Mohamed G. Soliman, M.D

CONTACT

[email protected]

00201018362537

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

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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