Bladder Outlet Obstruction Clinical Trial
Official title:
Antimuscarinics as the First-line Treatment for Male With International Prostate Symptom Score (IPSS) Voiding-to-storage Subscore Rati (IPSS-V/S)≤1-- A Prospective Randomized Study Comparing With α-blockers
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.
1. STUDY PROCEDURE
1.1.General Study Design 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 LUTS (IPSS-T ≥8)
and IPSS-V/S ≤1.
1.2. Study Visits and Evaluations
1.2.1 Screening Visit (Baseline, 1 day to 1 week of the first treatment day).
1.2.1.1 Explain the nature of the study and have patients to read and sign an Informed
Consent Form.
1.2.1.2 Screen patients for inclusion/exclusion criteria. 1.2.1.3 Medical History of lower
urinary tract symptoms and previous treatment modalities.
1.2.1.4 Vital signs monitoring, general physical examinations of all systems (including
digital rectal examination), serum prostatic specific antigen (PSA), and urinalysis.
1.2.1.5 Record Patient Perception of Bladder Condition (PPBC), IPSS (IPSS-T, IPSS voiding
(IPSS-V), and IPSS storage (IPSS-S)), Overactive Bladder Symptom Score (OAB-SS), and quality
of Life index (QoL-I)scores.
1.2.1.6 Obtain maximum flow rate (Qmax), voided volume, postvoid residual volume (PVR),
total prostate volume (TPV), and transitional zone index (TZI).
1.2.1.7 Randomized assigned patients into 2 groups; men in one group received Doxazosin 4 mg
QD, and those in the other group received Detrusitol 4 mg QD.
1.2.2 First Evaluation Visit (2 weeks after the initial treatment) 1.2.2.1 Vital signs
monitoring and record adverse events. 1.2.2.2 Record PPBC, IPSS (IPSS-T, IPSS-V, IPSS-S),
OAB-SS and QoL. 1.2.2.3 Check urinalysis for urinary tract infection if patient has symptoms
suggestive of urinary tract infection.
1.2.2.4 Check Qmax, voided volume, and PVR.
1.2.3 Second Evaluation Visit (4 weeks after the treatment). 1.2.3.1 Vital signs monitoring
and record adverse events. 1.2.3.3 Check urinalysis for urinary tract infection if patient
has symptoms suggestive of urinary tract infection.
1.2.3.4 Check Qmax, voided volume, and PVR.
1.2.4 Third Evaluation Visit (3 months after the treatment). 1.2.4.1 Vital signs monitoring
and record adverse events. 1.2.4.2 Record PPBC, IPSS (IPSS-T, IPSS-V, IPSS-S), OAB-SS and
QoL. 1.2.4.3 Check urinalysis for urinary tract infection if patient has symptoms suggestive
of urinary tract infection.
1.2.4.4 Check Qmax, voided volume, and PVR.
1.3. Withdrawal Criteria
Patients with any of the following conditions may be withdrawn from the trial:
1.3.1. Patients decide to withdraw their consent. 1.3.2. Patients indicate the status of
lack of efficacy which is of clinical significance judged by the investigators that may lead
to permanent damage to the patients.
1.3.3. Investigators consider that there is of safety concerns for the patients to remain in
the trial (such as development severe medical disease).
1.3.4. Lost of follow-up or death. 1.3.5. PVR≥300 mL
1.4. Concomitant Treatments Investigator will try to minimize the concomitant medications
for the patients during the trial duration. However, patients are allowed to continue taking
stable medication in stable dose for diseases other than genitourinary system.
1.5. Prohibited medication
Patients are not allowed to take any of the following medications during the study:
1. Anticholinergics other than test drug
2. Alpha-adrenergic receptor blockers
3. Tricyclic anti-depressants
4. Calcium channel blockers
5. Skeletal muscle relaxant
6. Cyclooxygenase-2 (COX-2) inhibitors
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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