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

June 23, 2014 updated by: Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

395

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Hualien, Taiwan, 970
        • Buddhist Tzu Chi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month after initial treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 1 month
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
Baseline and 1 month
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
Baseline and 1 month
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
Baseline and 1 month
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
Baseline and 1 month
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
Baseline and 1 month
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
Baseline and 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Buddhist Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 9, 2012

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCGHUROL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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