Health TrialsbyHealthPanel

Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

ConditionEnlarged Prostate With Lower Urinary Tract Symptoms
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age40-70
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vardenafil 5 Mg Oral Tablet

    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 )

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasiaExperimental treatment 1 intervention
Group B: Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasiaActive comparator 1 intervention
Group C: Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

International prostate symptom score (IPSS total score)

Change in pre and post treatment condition (IPSS : international prostate symptom score - decresing in the score equals improving the symptoms )

Time frame
3 months
2

The maximum urinary flow rate (Q-max)

Change in pre and post treatment condition (increasing at Q-max equals improving the symptoms )

Time frame
3 months

Secondary outcomes

1

Sexual Health Inventory for Men (SHIM)

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

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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