Overview

Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1

Status:
Completed
Trial end date:
2013-08-01
Target enrollment:
0
Participant gender:
Male
Summary
This study is a prospective randomized, open label, controlled, double arm, post-marketing study to compare the treatment efficacy of first-line antimuscarinics and α-blockers monotherapy for men with moderate to severe lower urinary tract symptoms (LUTS) (International Prostate Symptom Score (IPSS-T) ≥8) and IPSS voiding-to-storage subscore ratio (IPSS-V/S) ≤1.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Treatments:
Doxazosin
Muscarinic Antagonists
Tolterodine Tartrate
Criteria
Inclusion Criteria:

- Men aged ≥40 years with lower urinary tract symptoms (IPSS ≥8)

- Patient or his/her legally acceptable representative has signed the written informed
consent form

Exclusion Criteria:

- Patients with severe cardiopulmonary disease and such as congestive heart failure,
arrhythmia, poorly controlled hypertension, not able to receive regular follow-up

- Patients with urinary retention, urodynamically proven detrusor underactivity or PVR
≥250 mL

- Patients with known active urinary tract infection, urinary stone or malignancy

- Patients with history of urethral injury or transurethral surgery for prostate or
bladder

- Patients have laboratory abnormalities at screening including:

1. Aspartate aminotransferase (AST) >3 x upper limit of normal range

2. Alanine aminotransferase (ALT) >3 x upper limit of normal range

3. Patients have abnormal serum creatinine level >2 x upper limit of normal range

- Patients with any other serious disease or condition considered by the investigator
not suitable for entry into the trial

- Patients participated investigational drug trial within 1 month before entering this
study

- Patients with major psychiatric illness or drug abuse

- Patients taken medication such as alpha-blocker, antimuscarinic or 5 alpha-reductase
(5AR) inhibitor within 6 months