UnknownPhase 3

Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Egypt150 participantsStarted 2024-06-01

Plain-language 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.

Who can participate

Age range

40 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 .

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

International prostate symptom score (IPSS total score)

Timeframe: 3 months

The maximum urinary flow rate (Q-max)

Timeframe: 3 months

Trial details

NCT IDNCT06491108

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-01

Contact for this trial

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

00201020337967 hazem30839637@med.tanta.edu.eg

View on ClinicalTrials.gov More Enlarged Prostate With Lower Urinary Tract Symptoms trials