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

This study is currently recruiting participants.
Verified May 2013 by Buddhist Tzu Chi General Hospital
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: May 27, 2013
Last verified: May 2013
  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 LUTS (IPSS-T≥8) and 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 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 efficacy will be assessed using Patient Perception of Bladder Condition (PPBC) after the treatment day [ Time Frame: 2 weeks after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    The efficacy will be assessed using Patient Perception of Bladder Condition (PPBC) from baseline to 2 weeks, 1 month and 3 months; Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 "no problems at all" to 6 "many severe problems".

    Safety:

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



Secondary Outcome Measures:
  • The efficacy will be assessed using International Prostate Symptom Score (IPSS) questionnaires after the treatment day [ Time Frame: 2 weeks after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Net change of the total International Prostate Symptom Score (IPSS), IPSS subscore (IPSS-Voiding, IPSS-Storage) and IPSS QoL score from baseline to 2 weeks, 1 month and 3 months

    Safety:

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


  • The efficacy will be assessed using Overactive Bladder Symptom Score (OABSS) questionnaires after the treatment day [ Time Frame: 2 weeks after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Net change of the item scores and total score of Overactive Bladder Symptom Score (OABSS) from baseline to 2 weeks, 1 month and 3 months

    Safety:

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


  • To evaluate change of the total prostate volume (TPV) at different time points [ Time Frame: 2 weeks after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Net change of the following parameters (total prostate volume (TPV)) from baseline to 2 weeks, 1 month and 3 months

    Safety:

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


  • To evaluate change of Transition zone index (TZI) at different time points [ Time Frame: 2 weeks after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Net change of the following parameters (transition zone index (TZI)) from baseline to 2 weeks, 1 month and 3 months

    Safety:

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


  • To evaluate change of Maximum flow rate (Qmax) at different time points [ Time Frame: 2 weeks after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Net change of the following parameters (maximum flow rate (Qmax)) from baseline to 2 weeks, 1 month and 3 months

    Safety:

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


  • To evaluate change of voided volume at different time points [ Time Frame: 2 weeks after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Net change of the following parameters (voided volume) from baseline to 2 weeks, 1 month and 3 months

    Safety:

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


  • To evaluate change of postvoid residual volume (PVR) at different time points [ Time Frame: 2 weeks after initial treatment ] [ Designated as safety issue: Yes ]

    Efficacy:

    Net change of the following parameters (postvoid residual volume (PVR)) from baseline to 2 weeks, 1 month and 3 months

    Safety:

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



Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated 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. AST>3 x upper limit of normal range
    2. 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 5AR inhibitor within 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01661621

Contacts
Contact: Hann-Chorng Kuo, M.D. 886-3-8561825 ext 2113 hck@tzuchi.com.tw
Contact: Dong-Ling Tang, Miss 886-3-8561825 ext 2117 dong_lin86@yahoo.com.tw

Locations
Taiwan
Buddhist Tzu Chi General Hospital Recruiting
Hualien, Taiwan, 970
Contact: Hann-Chorng Kuo, M.D.    886-3-8561825 ext 2113    hck@tzuchi.com.tw   
Contact: Dong-Ling Tang, Miss    886-3-8561825 ext 2117    dong_lin86@yahoo.com.tw   
Principal Investigator: Hann-Chorng Kuo, M.D.         
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
Last Updated: May 27, 2013
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:
Urethral Diseases
Urinary Bladder Neck Obstruction
Urethral Obstruction
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 April 21, 2014