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The effect of Tadalafil on night time frequency refractory to treatment with alfa-adrenergic inhibitors

Evaluation and comparison of the effect of Tadalafil and placebo on nighttime frequency refractory to treatment with alfa-adrenergic inhibitors in males with LUTS/BPH referred to Razi Hospital

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201208091853N9
Enrollment
100
Registered
2016-05-13
Start date
2014-08-06
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

Nocturnal frequency or nocturia. Polyuria

Interventions

Intervention 1: tadalafil 5mg, daily for 12 weeks Made in Iran. Intervention 2: placebo, daily for 12 weeks Made in Iran.
Treatment - Drugs
tadalafil 5mg, daily for 12 weeks Made in Iran
placebo, daily for 12 weeks Made in Iran

Sponsors

Vice chancellor for research, Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
50 Years to 149 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age above 50, refractory LUTS to life style change such as: quite smoking and limit consumption of liquid alcohol and caffeine before sleeping, having moderate physical activity. Exclusion criteria: BMI above 30kg/m2, surgery indication for BPH, urinary residual above 200CC, chronic pelvic pain syndrome (CPPS) over active bladder (OAB) urethral or bladder stone, history of pervious neurogenic bladder ureteral or bladder stone history of urethral bladder or prostate malignancy, PSA above 4 ng/ml or PSA between 4-10 ng/ml with positive biopsy for prostate malignancy, active urinary tract infection (UTI) or active sexual transmitted disease (STD)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Nocturia. Timepoint: 2, 4, 8 and 12 weeks after intervention. Method of measurement: Examination and evaluation by Night Time Voiding Diary, SPSS and Quality of Life score questionnaires, and uroflowmetry (Maximum Flow Rate or Qmax).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Keivan Gholamjani Moghadam

Guilan University of Medical Sciences

urc1384@yahoo.com+98 13 3352 5259

Outcome results

None listed

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