Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Last updated: July 5, 2024
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

3

Condition

Prostate Disorders

Enuresis

Interstitial Cystitis

Treatment

Vardenafil 5 Mg Oral Tablet

Clinical Study ID

NCT06491108
Vardenafil for BPH / LUTS
  • Ages 40-70
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sexually active patients .

  2. ModerateBPH related LUTS ( bengin prostatic hyperplasia related lower urinary tractsymtoms ) i.e: (international prostatic symptom score 8 to 19 : the higher score isthe worse symptoms ).

  3. Patients accepted medical treatment and completed 12 weeks on medical treatment andstrict follow up .

Exclusion

Exclusion Criteria:

  1. Indication for combined therapy as prostate size over 40 gm .

  2. Gross hematuria.

  3. Refractory urine retention .

  4. Bilateral hydro-ureteronephrosis or renal insufficiency secondary to benginprostatic hyperplasia.

  5. Bladder diverticula or calculi .

  6. History of bladder or prostate cancer.

  7. Unwilling patients to medical therapy.

  8. History of pelvic surgery or urethral stricture.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Vardenafil 5 Mg Oral Tablet
Phase: 3
Study Start date:
June 01, 2024
Estimated Completion Date:
July 01, 2025

Study Description

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.

Connect with a study center

  • Faculity of medicine - Tanta university

    Tanta, Gharbia 31528
    Egypt

    Active - Recruiting

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