Trial · NCT01661621
Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1
NCT01661621, Phase 4, Completed, Buddhist Tzu Chi General Hospital; results first posted 2014-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1. Trials, record NCT01661621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01661621
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antimuscarinics as the First-line Treatment for Male With IPSS-V/S≤1
- NCT number
- NCT01661621
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 395 participants, actual
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Conditions
- Bladder Outlet Obstruction
- Interventions
- Detrusitol 4 mg QD, Doxazosin 4 mg QD
- First posted
- 2012-08-09
- Last updated
- 2014-06-25
- Results first posted
- 2014-06-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Global Response Assessment (GRA) After the Treatment Day | 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 |
| Secondary | The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day | 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 |
| Secondary | The Maximum Flow Rate (Qmax) After the Treatment Day | 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 |
| Secondary | The Voided Volume After the Treatment Day | 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 |
| Secondary | The Postvoid Residual Volume (PVR) After the Treatment Day | 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 |
| Secondary | The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day | 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 |
| Secondary | The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day | 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 |
| Secondary | The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day | 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 |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Global Response Assessment (GRA) After the Treatment Day | 1 month after initial treatment | participants | NUMBER | |
| SECONDARY | The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day | Baseline and 1 month | units on a scale | MEAN | |
| SECONDARY | The Maximum Flow Rate (Qmax) After the Treatment Day | Baseline and 1 month | mL/s | MEAN | |
| SECONDARY | The Voided Volume After the Treatment Day | Baseline and 1 month | mL | MEAN | |
| SECONDARY | The Postvoid Residual Volume (PVR) After the Treatment Day | Baseline and 1 month | mL | MEAN | |
| SECONDARY | The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day | Baseline and 1 month | units on a scale | MEAN | |
| SECONDARY | The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day | Baseline and 1 month | units on a scale | MEAN | |
| SECONDARY | The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day | Baseline and 1 month | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Global Response Assessment (GRA) After the Treatment Day | Group 1 | GRA≥1 | 89 | participants | |
| The Global Response Assessment (GRA) After the Treatment Day | Group 2 | GRA≥1 | 218 | participants | |
| The Global Response Assessment (GRA) After the Treatment Day | Group 1 | GRA<1 | 27 | participants | |
| The Global Response Assessment (GRA) After the Treatment Day | Group 2 | GRA<1 | 61 | participants | |
| The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day | Group 1 | Baseline | 14.8 | Standard Deviation 5.40 | units on a scale |
| The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day | Group 2 | Baseline | 18.0 | Standard Deviation 6.47 | units on a scale |
| The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day | Group 1 | 1 month | 11.2 | Standard Deviation 6.81 | units on a scale |
| The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day | Group 2 | 1 month | 10.8 | Standard Deviation 6.36 | units on a scale |
| The Maximum Flow Rate (Qmax) After the Treatment Day | Group 1 | Baseline | 13.1 | Standard Deviation 8.10 | mL/s |
| The Maximum Flow Rate (Qmax) After the Treatment Day | Group 2 | Baseline | 11.4 | Standard Deviation 5.95 | mL/s |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 116 | |
| Overall Study | STARTED | Group 2 | 279 | |
| Overall Study | COMPLETED | Group 1 | 116 | |
| Overall Study | COMPLETED | Group 2 | 279 | |
| Overall Study | NOT COMPLETED | Group 1 | 0 | |
| Overall Study | NOT COMPLETED | Group 2 | 0 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | General disorders | Group 1 | 12 | 116 | |
| other | Dizziness | General disorders | Group 2 | 0 | 279 | |
| other | General weakness | General disorders | Group 1 | 3 | 116 | |
| other | General weakness | General disorders | Group 2 | 0 | 279 | |
| other | Palpitation | General disorders | Group 1 | 3 | 116 | |
| other | Palpitation | General disorders | Group 2 | 0 | 279 | |
| other | Dry mouth | General disorders | Group 1 | 0 | 116 | |
| other | Dry mouth | General disorders | Group 2 | 13 | 279 | |
| other | Blurred vision | General disorders | Group 1 | 0 | 116 | |
| other | Blurred vision | General disorders | Group 2 | 10 | 279 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | ||
| Total, all-cause mortality | Group 2 | ||
| Total, other adverse events | Group 1 | 18 | 116 |
| Total, other adverse events | Group 2 | 33 | 279 |
| Total, serious adverse events | Group 1 | 0 | 116 |
| Total, serious adverse events | Group 2 | 0 | 279 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1 vs Group 2: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01661621
GET https://conductscience.org/api/trials/v1/NCT01661621/results?page=2