Phase 4
N=395
Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1
Bladder Outlet Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT01661621 ↗Enrolled (actual)
395
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: The Global Response Assessment (GRA) After the Treatment Day — 89; 218; 27; 61 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Detrusitol 4 mg QD (Drug); Doxazosin 4 mg QD (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Buddhist Tzu Chi General Hospital
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Global Response Assessment (GRA) After the Treatment Day |
89; 218; 27; 61 | — |
| SECONDARY The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day |
14.8; 18.0; 11.2; 10.8 | — |
| SECONDARY The Maximum Flow Rate (Qmax) After the Treatment Day |
13.1; 11.4; 13.6; 13.6 | — |
| SECONDARY The Voided Volume After the Treatment Day |
212.5; 244.0; 231.6; 268.3 | — |
| SECONDARY The Postvoid Residual Volume (PVR) After the Treatment Day |
50.1; 53.9; 60.4; 42.9 | — |
| SECONDARY The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day |
5.31; 12.3; 4.84; 6.49 | — |
| SECONDARY The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day |
9.51; 5.70; 6.40; 4.31 | — |
| SECONDARY The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day |
3.91; 3.88; 2.82; 2.82 | — |
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.
Eligibility 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:
- Aspartate aminotransferase (AST) >3 x upper limit of normal range
- Alanine aminotransferase (ALT) >3 x upper limit of normal range
- 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
Data sourced from ClinicalTrials.gov (NCT01661621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.