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tadalafil in BPH

Comparison of the effect of different doses of tadalafil on urinary symptoms and urodynamic findings in Benign Prostatic Hyperplasia patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241027063519N1
Enrollment
264
Registered
2025-01-05
Start date
2025-01-09
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BENIGN PROSTATIC HYPERPLASIA. Enlarged prostate

Interventions

Intervention 1: The group receiving a dose of 10 mg tadalafil from Farabi Pharmaceuticals daily for 12 weeks, once a day. Intervention 2: The group receiving a dose of 20mg tadalafil from Farabi Pharm

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: Age more than 45 years Patient satisfaction Having symptoms of Lower Urinary Tract Syndrom( LUTS) for at least 4 weeks Prostate-specific antigen( PSA) lesser than 4 nm Post Void Residual( PVR) volume 300 ml or more Qmax 4 to 15 mL/s of pre-void bladder volume

Exclusion criteria

Exclusion criteria: Lack of consent to participate in the study Severe liver or kidney failure Simultaneous use of nitrates

Design outcomes

Primary

MeasureTime frame
Presence or absence of lower urinary tract symptoms. Timepoint: Before starting the medication and after 12 weeks of taking the medication. Method of measurement: checklist.

Secondary

MeasureTime frame
The volume remaining in the bladder after voiding. Timepoint: At the beginning of the study and after twelve weeks of taking tadalafil tablets. Method of measurement: Urodynamic test.;Maximum urine flow( Qmax). Timepoint: At the beginning of the study and after twelve weeks of taking tadalafil tablets. Method of measurement: Urodynamic test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRasool Jafari

Arak University of Medical Sciences

Ra.jafari009@yahoo.com+98 86 3313 6055

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026