Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

NCT06491108 | Recruiting Phase 3

• 1 other identifier: Vardenafil for BPH / LUTS
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Enlarged Prostate With Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Sexual Health Inventory for Men (SHIM)

  3 months

Study Arms (3)

Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia

EXPERIMENTAL

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

Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia

ACTIVE COMPARATOR

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

Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia

ACTIVE COMPARATOR

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

Interventions

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 )

Also known as: Vardenafil 5 mg

Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia; Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia; Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia

Eligibility Criteria

• Age: 40 Years - 70 Years
• Gender Eligibility Details: male gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculity of medicine - Tanta university

Tanta, Gharbia Governorate, 31528, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 32012409 BACKGROUND

• 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.

  PMID: 18281145 RESULT

MeSH Terms

Interventions

Vardenafil Dihydrochloride; Tablets

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hazem B. Baz, M.B.B.Ch

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

00201020337967; hazem30839637@med.tanta.edu.eg

Mohamed G. Soliman, M.D

CONTACT

00201018362537; mohamed.soliman@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology resident at Tanta university hospitals

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: June 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)