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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier:
NCT01661621
First received: August 2, 2012
Last updated: June 23, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 Buddhist Tzu Chi General Hospital:

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

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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
Other Name: Detrusitol 4 mg QD
Experimental: Group 2
α-blockers (Doxazosin 4 mg QD)
Drug: Doxazosin 4 mg QD
Group 2
Other Name: Doxazosin 4 mg QD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 2, 2012
Results First Received: April 21, 2014
Last Updated: June 23, 2014
Health Authority: Taiwan: Department of Health
Taiwan: Research Ethics Committee

Keywords provided by 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
Muscarinic Antagonists
Tolterodine
Doxazosin
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 22, 2014