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The assessment of effect of Tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia

The assessment of effect of Tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia on patients treated with standard medication

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201008094541N1
Enrollment
132
Registered
2010-10-18
Start date
2009-02-05
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Benighn Prostatic Hypertrophia. Benign Prostatic Hypertrophia

Interventions

Placebo
Treatment - Drugs
Placebo tablet at 10 pm every night for 12 weeks
Tadalafil tablet 10mg at 10 pm every night for 12 weeks
Intervention 1: Placebo tablet at 10 pm every night for 12 weeks. Intervention 2: Tadalafil tablet 10mg at 10 pm every night for 12 weeks.

Sponsors

Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with score > 8 and without any indications for prostatic surgery such as recurrent retention, persistent gross hematuria, permanent urinary infections associated with BPH, renal function failure and hydronephrosis, bladder stone due to BPH, under previous standard medical treatment with prazocine (max doze 10mg) daily with or without Finastride (5 mg, daily, for 3 months). Response to medication should be in plateau level

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
International score of prostatic signs & symptoms. Timepoint: Baseline and 3 months after the intervention. Method of measurement: IPSS: International Prostatic Symptom Score.

Secondary

MeasureTime frame
Urinary satisfaction. Timepoint: Baseline and 3 months after the intervention. Method of measurement: (IPSS: International Prostatic Symptom Score).;Maximum urinary flow. Timepoint: Baseline and 3 months after the intervention. Method of measurement: Uroflometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Amin Afshari Moghaddam

Urology Research Center

urc@gums.ac.ir+98 13 1552 5259

Outcome results

None listed

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