Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Phase 3

Recruiting

• Conditions: Enlarged Prostate With Lower Urinary Tract Symptoms
• Interventions: Drug: Vardenafil 5 Mg Oral Tablet

• Registration Number: NCT06491108
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-06-29
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-05
• Last Update Submitted: 2024-07-05
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia	Vardenafil 5 Mg Oral Tablet	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
Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia	Vardenafil 5 Mg Oral Tablet	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
Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia	Vardenafil 5 Mg Oral Tablet	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculity of medicine - Tanta university; 🇪🇬 Tanta, Gharbia, Egypt