Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Enlarged Prostate With Lower Urinary Tract Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Vardenafil 5 Mg Oral Tablet

Intervention Type 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 )

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

Group Type ACTIVE_COMPARATOR

Vardenafil 5 Mg Oral Tablet

Intervention Type 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 )

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

Group Type ACTIVE_COMPARATOR

Vardenafil 5 Mg Oral Tablet

Intervention Type 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 )

Interventions

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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 )

Intervention Type DRUG

Other Intervention Names

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Vardenafil 5 mg

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No