Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1
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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 |
- 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
- 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 |
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:
- AST>3 x upper limit of normal range
- ALT>3 x upper limit of normal range
- 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| 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 |
| 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. | |
| 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 June 17, 2013