Effects of tadalafil on postvoided dribbling

Effects of daily tadalafil 5mg administration on post-voided dribbling (PVD) in men with lower urinary tract symptoms: A Prospective, Multicenter, Double-blind, Placebo-Controlled, Randomized Clinical Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002232

Enrollment

102

Registered

2017-02-21

Start date

2017-11-27

Completion date

Unknown

Last updated

2020-03-23

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

Conditions

None listed

Interventions

Drug : experimental group: once a daily oral administration of tadalafil 5mg for 12 weeks control group : once a daily oral administration of placebo for 12 weeks

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. 20 = age < 70 2. intenational prostate symptome score >8 3. Hallym post voided dribbling questionnaire >1 4. He must have a sexual partner and have a sexual relationship more than two per a month 5. He voluntarily participated in this study

Exclusion criteria

Exclusion criteria: (1) stroke, myocardial infarction,Coronary artery bypass graft surgery history with in 6 months (2) cardiac failure, unstable angina, life-threatening arrhythmia with in 6 months (3) uncontrolled Diabetes mellitus (HbA1C > 12%) (4) proliferative diabetic retinopathy (5) Spinal injury, pelvic surgery history (6) lower blood pressure thant 90/50mmHg, higher blood pressure more than170/100mmHg (7) penile curvature, urethral stricture, Pyeronie's disease (8) abnormal liver or renal function (9)retinitis pigmentosa (10) active peptic ulceration within 1 year (11) Obvious candidate of Priapism (leukemia..) (12) congenital QT prolongation syndrome patinet, drug medication with prolonged QT interval (13) psychotic disorder (14) Nitrates/Nitric oxide(NO) donor(ex. nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, Sodium nitroprusside) (15)cancer chemotherapy (16) anticoagulants medication (17) affect for metabolism CYP3A4 (18) other phosphodiesterase-5 (PDE5) inhibitor medication within 2 weeks (19) other Randomized Clinical Trial participants (20) hypersensitivity history associated with phosphodiesterase-5 (PDE5) inhibitor

Design outcomes

Secondary

Measure	Time frame
Scores of International Index of Erectile Function 15	—

Primary

Measure	Time frame
Quantitative Evaluation of Post-Voided Dribbling using paper towel ;Scores of Post Voided Dribbling Questionnaire	—

Countries

Korea, Republic of

Contacts

Public ContactWon Ki Lee

Hallym University Medical Center- Chuncheon

Outcome results