Clinical trial NCT06491108: Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
Official title: Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Enlarged Prostate With Lower Urinary Tract Symptoms
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 150
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: International prostate symptom score (IPSS total score)
timeFrame: 3 months
measure: The maximum urinary flow rate (Q-max)
timeFrame: 3 months
Secondary outcomes:
measure: Sexual Health Inventory for Men (SHIM)
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculity of medicine - Tanta university
state: Gharbia
Study officials:
affiliation: Tanta University
name: Hazem B. Baz, M.B.B.Ch
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.