A Phase 4 interventional study of Detrusitol 4 mg QD and Doxazosin 4 mg QD in Bladder Outlet Obstruction, sponsored by Buddhist Tzu Chi General Hospital. Completed at 1 site in Taiwan. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2014-06-25.
Sponsored by Buddhist Tzu Chi General Hospital · Phase 4, Interventional, and Treatment
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.
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:
46 studies on the registry are indexed under Urinary Bladder Neck Obstruction; 10 are open to participants now.
This study's enrollment of 395 is above the median of 88 across 30 interventional studies indexed under Urinary Bladder Neck Obstruction.
Browse Urinary Bladder Neck Obstruction studies →Buddhist Tzu Chi General Hospital is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients have laboratory abnormalities at screening including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Antimuscarinics (Detrusitol 4 mg QD)
Drug: Detrusitol 4 mg QD
α-blockers (Doxazosin 4 mg QD)
Drug: Doxazosin 4 mg QD
Group 1
Group 2
The Global Response Assessment (GRA) After the Treatment Day
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
Time frame: 1 month after initial treatment
The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day
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
Time frame: Baseline and 1 month
The Maximum Flow Rate (Qmax) After the Treatment Day
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
Time frame: Baseline and 1 month
The Voided Volume After the Treatment Day
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
Time frame: Baseline and 1 month
The Postvoid Residual Volume (PVR) After the Treatment Day
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
Time frame: Baseline and 1 month
The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day
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
Time frame: Baseline and 1 month
The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day
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
Time frame: Baseline and 1 month
The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day
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
Time frame: Baseline and 1 month
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 116 | 279 |
| Completed | 116 | 279 |
| Not completed | 0 | 0 |
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
| participants | Group 1 | Group 2 |
|---|---|---|
| GRA≥1 | 89 | 218 |
| GRA<1 | 27 | 61 |
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
| units on a scale | Group 1 | Group 2 |
|---|---|---|
| Baseline | 14.8 ± 5.40 | 18.0 ± 6.47 |
| 1 month | 11.2 ± 6.81 | 10.8 ± 6.36 |
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
| mL/s | Group 1 | Group 2 |
|---|---|---|
| Baseline | 13.1 ± 8.10 | 11.4 ± 5.95 |
| 1 month | 13.6 ± 7.90 | 13.6 ± 6.63 |
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
| mL | Group 1 | Group 2 |
|---|---|---|
| Baseline | 212.5 ± 168.8 | 244.0 ± 148.3 |
| 1 month | 231.6 ± 163.6 | 268.3 ± 150.7 |
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
| mL | Group 1 | Group 2 |
|---|---|---|
| Baseline | 50.1 ± 62.6 | 53.9 ± 58.7 |
| 1 month | 60.4 ± 60.4 | 42.9 ± 49.3 |
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
| units on a scale | Group 1 | Group 2 |
|---|---|---|
| Baseline | 5.31 ± 3.51 | 12.3 ± 4.37 |
| 1 month | 4.84 ± 4.75 | 6.49 ± 4.97 |
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
| units on a scale | Group 1 | Group 2 |
|---|---|---|
| Baseline | 9.51 ± 3.05 | 5.70 ± 3.09 |
| 1 month | 6.40 ± 3.47 | 4.31 ± 2.80 |
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
| units on a scale | Group 1 | Group 2 |
|---|---|---|
| Baseline | 3.91 ± 1.01 | 3.88 ± 0.82 |
| 1 month | 2.82 ± 1.18 | 2.82 ± 0.96 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | — | 0/116 (0%) | 18/116 (15.5%) |
| Group 2 | — | 0/279 (0%) | 33/279 (11.8%) |
| Event | Group 1 | Group 2 |
|---|---|---|
| DizzinessGeneral disorders | 12/116 | 0/279 |
| Dry mouthGeneral disorders | 0/116 | 13/279 |
| Blurred visionGeneral disorders | 0/116 | 10/279 |
| General weaknessGeneral disorders | 3/116 | 0/279 |
| PalpitationGeneral disorders | 3/116 | 0/279 |
| Dry eyeGeneral disorders | 0/116 | 7/279 |
| ConstipationGeneral disorders | 0/116 | 3/279 |
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 68.4 ± 11.3 | 65.6 ± 10.5 | 66.4 ± 10.8 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 116 | 279 | 395 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Taiwan | 116 | 279 | 395 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Tolterodine · Doxazosin
Urinary Bladder Neck Obstruction →
Buddhist Tzu Chi General Hospital