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The efficacy and safety of Tadarafil for treatment of nocturia and sleep quality

The efficacy and safety of Tadarafil for treatment of nocturia and sleep quality - The efficacy of Tadarafil for nocturia and sleep disturbance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018292
Enrollment
50
Registered
2015-07-13
Start date
2015-03-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Disease with lower urinary tract symptom

Interventions

5mg of Tadarafil is administered to the patients once a day for 12 weeks

Sponsors

Fujita Health University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.Patients with nocturia(OABSS Total Score 3 or more and Q2 2 or more ) 2.Patients who are considered eligible for the study by the attending physician 3.Patients who can understand the contents of the questionnaire without the help of others, and who can answer on their own 4.Patients who voluntarily provide written consent to participate in the study

Exclusion criteria

Exclusion criteria: 1.Patients with a history of hypersensitivity to components of this drug 2.Patients with a history of serious cardiovascular (It have been reported heart rate increases, and there is a risk that symptoms worse. 3.Patients with severe hypertension 4.Patients with severe liver dysfunction (Child-Pugh score 10 or more) [There is a possibility that the blood concentration is excessively increased.] 5.Patients treated with flecainide acetate or propafenone hydrochloride in administration 6.Patients with chronic bacterial prostatitis or activity of urinary tract infection 7.Patients who carried the radiation therapy to the pelvis 8.Patients who suspected of having prostate cancer by PSA or rectal examination 9.Patients with urethral stricture 10.Patients who are considered ineligible for the study by the attending physician

Design outcomes

Primary

MeasureTime frame
Improving of urinary symptom score and sleep quality after 12 weeks medication

Secondary

MeasureTime frame
IPSS, QOL, OABSS, athene sleeing score, diary of urination

Countries

Japan

Contacts

Public ContactHitomi Sasaki

Fujita Health University Medicine/Department of Urology

sasakih@fujita-hu.ac.jp0562-93-9257

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026