Clinical trial NCT01661621: Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bladder Outlet Obstruction
Keywords: Lower urinary tract symptoms (LUTS)
International Prostate Symptom Score (IPSS)
Antimuscarinics
α-blockers
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 395
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

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:

  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

Primary outcomes:
measure: The Global Response Assessment (GRA) After the Treatment Day
timeFrame: 1 month after initial treatment
Secondary outcomes:
measure: The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day
timeFrame: Baseline and 1 month
measure: The Maximum Flow Rate (Qmax) After the Treatment Day
timeFrame: Baseline and 1 month
measure: The Voided Volume After the Treatment Day
timeFrame: Baseline and 1 month
measure: The Postvoid Residual Volume (PVR) After the Treatment Day
timeFrame: Baseline and 1 month
measure: The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day
timeFrame: Baseline and 1 month
measure: The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day
timeFrame: Baseline and 1 month
measure: The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day
timeFrame: Baseline and 1 month
Other outcomes:
Locations:
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
Study officials:
affiliation: Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
name: Hann-Chorng Kuo, M.D.
role: PRINCIPAL_INVESTIGATOR
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