Enlarged Prostate With Lower Urinary Tract Symptoms
Conditions
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.
Interventions
DRUGVardenafil 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 )
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
40 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 ) |
Countries
Egypt
Contacts
Primary ContactHazem B. Baz, M.B.B.Ch
Backup ContactMohamed G. Soliman, M.D
Outcome results
None listed