Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Enlarged Prostate With Lower Urinary Tract Symptoms
• Intervention / Treatment: Drug: Vardenafil 5 Mg Oral Tablet

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hazem B. Baz, M.B.B.Ch; Phone Number: 00201020337967; Email: hazem30839637@med.tanta.edu.eg
• Study Contact Backup: Name: Mohamed G. Soliman, M.D; Phone Number: 00201018362537; Email: mohamed.soliman@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 31528
      • Recruiting
      • Faculity of medicine - Tanta university
      • Contact: Mohamed G. Soliman, MD; Phone Number: 01018362537; Email: mohamed.soliman@med.tanta.edu.eg
      • Contact: Ahmed R. Abouramadan, MD; Phone Number: 01001424064; Email: ahmed.abouramadan@med.tanta.edu.eg
      • Principal Investigator: Mohamed G. Soliman, MD
      • Principal Investigator: Hazem B. Baz, M.B.B.Ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Sexually active patients .
2. 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 ).
3. Patients accepted medical treatment and completed 12 weeks on medical treatment and strict follow up .

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 bengin prostatic 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia; 50 patients will take Vardenafil 5 mg tabs twice daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects	Drug: Vardenafil 5 Mg Oral Tablet; 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
Active Comparator: Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia; 50 patients will take Tadalafil 5 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects	Drug: Vardenafil 5 Mg Oral Tablet; 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
Active Comparator: Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia; 50 patients will take Tamsulosin 0.4 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects	Drug: Vardenafil 5 Mg Oral Tablet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International prostate symptom score (IPSS total score)	Change in pre and post treatment condition (IPSS : international prostate symptom score - decresing in the score equals improving the symptoms )	3 months
The maximum urinary flow rate (Q-max)	Change in pre and post treatment condition (increasing at Q-max equals improving the symptoms )	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Health Inventory for Men (SHIM)	Change in pre and post treatment condition (SHIM: Sexual Health Inventory for Men - increasing in the score equals improving the symptoms )	3 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Hazem B. Baz, M.B.B.Ch, Tanta University

Publications and helpful links

General Publications

• Nagasubramanian S, John NT, Antonisamy B, Mukha RP, Jeyachandra Berry CS, Kumar S, Devasia A, Kekre NS. Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double-blinded, randomised controlled trial. BJU Int. 2020 May;125(5):718-724. doi: 10.1111/bju.15027. Epub 2020 Feb 27.
• Stief CG, Porst H, Neuser D, Beneke M, Ulbrich E. A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol. 2008 Jun;53(6):1236-44. doi: 10.1016/j.eururo.2008.01.075. Epub 2008 Feb 4.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 29, 2024
• First Submitted That Met QC Criteria: July 5, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Vardenafil Dihydrochloride
• Other Study ID Numbers: Vardenafil for BPH / LUTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No