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

JRCT ID: jRCT1051200099

Registered date:18/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: benign prostatic hyperplasia
• Date of first enrollment: 18/12/2020
• Target sample size: 200
• Study type: Interventional
• Intervention(s): crossovertrial

Outcome(s)

• Primary Outcome: The amount of change of the international prostate symptom score (IPSS) in each drug dosage start 12 weeks later

Secondary Outcome

The 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
• Gender: Male

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Ukimura Osamu