NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1051200099

Registered date:18/12/2020

COMPARISON OF TADALAFIL AND TAMSULOSIN IN THE TREATMENT OF MALE LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA : A RANDOMIZED, CROSSOVER STUDY

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedbenign prostatic hyperplasia
Date of first enrollment18/12/2020
Target sample size200
Countries of recruitment
Study typeInterventional
Intervention(s)crossovertrial

Outcome(s)

Primary OutcomeThe amount of change of the international prostate symptom score (IPSS) in each drug dosage start 12 weeks later
Secondary OutcomeThe amount of change of the following item each drug dosage start 12 weeks later QOL, IPSS-vas, overactivity bladder symptom score (OABSS), OABSS-vas, individual score of IPSS, NIH- Chronic Prostatitis Symptom Index (NIH-CPSI), a satisfaction questionnaire, adverse event and side effect

Key inclusion & exclusion criteria

Age minimum>= 50age old
Age maximum< 90age old
GenderMale
Include criteria1) male patients (50 years or older, male patient younger than 90 years,and prostate volume is 20 mL or more In the sonography,and IPSS score 8 or more, and QOL score 3 or more) 2) the patients who acquired an agreement for participation of this study
Exclude criteria1) the patients with prostate cancer 2) the patients with neurogenic bladder 3) the patients who was treated with other alpha1blockers or drug for overactive bladder 4) the patients who Tadalafil is administration contraindication 5) the patient who was judged to be inappropriateby by a doctor

Related Information

Contact

Public contact
Name Atuko Iwata
Address 465 kajiityou kawaramachi-hirokoji,kyoto,japan Kyoto Japan 602-8566
Telephone +81-75-251-5595
E-mail fujihara@koto.kpu-m.ac.jp
Affiliation University Hospital Kyoto Prefectural University of Medicine
Scientific contact
Name Osamu Ukimura
Address 465 kajiityou kawaramachi-hirokoji,kyoto,japan Kyoto Japan 602-8566
Telephone +81-75-251-5595
E-mail ukimura@koto.kpu-m.ac.jp
Affiliation University Hospital Kyoto Prefectural University of Medicine