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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01661621
First Posted: August 9, 2012
Last Update Posted: June 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
  Purpose
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.

Condition Intervention Phase
Bladder Outlet Obstruction Drug: Detrusitol 4 mg QD Drug: Doxazosin 4 mg QD Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital:

Primary Outcome Measures:
  • The Global Response Assessment (GRA) After the Treatment Day [ Time Frame: 1 month after initial treatment ]

    Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.

    The global response assessment on a 6-point scale ranging from 1 "No problems at all" to 6 "Many severe problems".

    Changes of the global response assessment (GRA) improved or reduction by 1 points.

    Change = Baseline minus Month 1 value

    Safety:

    Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness



Secondary Outcome Measures:
  • The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day [ Time Frame: Baseline and 1 month ]

    Efficacy:

    Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.

    The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always".

    Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35

    Safety:

    Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness


  • The Maximum Flow Rate (Qmax) After the Treatment Day [ Time Frame: Baseline and 1 month ]

    Efficacy:

    Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.

    Safety:

    Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness


  • The Voided Volume After the Treatment Day [ Time Frame: Baseline and 1 month ]

    Efficacy:

    Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.

    Safety:

    Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness


  • The Postvoid Residual Volume (PVR) After the Treatment Day [ Time Frame: Baseline and 1 month ]

    Efficacy:

    Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.

    Safety:

    Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness


  • The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day [ Time Frame: Baseline and 1 month ]

    Efficacy:

    Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.

    The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.

    The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).

    Safety:

    Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness


  • The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day [ Time Frame: Baseline and 1 month ]

    Efficacy:

    Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.

    The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.

    The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).

    Safety:

    Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness


  • The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day [ Time Frame: Baseline and 1 month ]

    Efficacy:

    Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.

    The IPSS quality of life question score on a 7-point scale ranging from 0 "Delighted" to 6 "Terrible".

    IPSS-QoL ranges 0 to 6 (Delighted to Terrible)

    Safety:

    Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness



Enrollment: 395
Study Start Date: August 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Antimuscarinics (Detrusitol 4 mg QD)
Drug: Detrusitol 4 mg QD
Group 1
Experimental: Group 2
α-blockers (Doxazosin 4 mg QD)
Drug: Doxazosin 4 mg QD
Group 2

  Hide Detailed Description

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661621


Locations
Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan, 970
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
Principal Investigator: Hann-Chorng Kuo, M.D. Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
  More Information

Publications:

Responsible Party: Hann-Chorng Kuo, Department of Urology, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT01661621     History of Changes
Other Study ID Numbers: TCGHUROL002
First Submitted: August 2, 2012
First Posted: August 9, 2012
Results First Submitted: April 21, 2014
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital:
Lower urinary tract symptoms (LUTS)
International Prostate Symptom Score (IPSS)
Antimuscarinics
α-blockers

Additional relevant MeSH terms:
Urinary Bladder Neck Obstruction
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases
Doxazosin
Tolterodine Tartrate
Muscarinic Antagonists
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Urological Agents