Bladder Outlet ObstructionPhase 4NCT01661621

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

A Phase 4 study testing Detrusitol 4 mg QD and Doxazosin 4 mg QD in people with Bladder Outlet Obstruction, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 40 years and older, men only
Conditions the study is for: Bladder Outlet Obstruction
What is being tested?: Detrusitol 4 mg QD and Doxazosin 4 mg QD
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 395 participants
Where: 1 siteTaiwan
Study dates: Aug 2012to Aug 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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:
Aspartate aminotransferase (AST) >3 x upper limit of normal range

Show all 12Show fewer

Alanine aminotransferase (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 5 alpha-reductase (5AR) inhibitor within 6 months

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Buddhist Tzu Chi General Hospital
Hualien City, 970

Other trials in Taiwan

About this study

Official title: 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

Read the detailed description

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:

Anticholinergics other than test drug
Alpha-adrenergic receptor blockers
Tricyclic anti-depressants
Calcium channel blockers
Skeletal muscle relaxant
Cyclooxygenase-2 (COX-2) inhibitors

Conditions: Bladder Outlet Obstruction
Being tested: Detrusitol 4 mg QD, Doxazosin 4 mg QD
Keywords: Lower urinary tract symptoms (LUTS), International Prostate Symptom Score (IPSS), Antimuscarinics, α-blockers
Medical subject headings: Urinary Bladder Neck Obstruction, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Detrusitol 4 mg QDDrug
Group 1
Doxazosin 4 mg QDDrug
Group 2

Study groups in NCT01661621
Study group	Role	What they receive
Group 1	Experimental	Antimuscarinics (Detrusitol 4 mg QD) Receives: Drug: Detrusitol 4 mg QD
Group 2	Experimental	α-blockers (Doxazosin 4 mg QD) Receives: Drug: Doxazosin 4 mg QD

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 month after initial treatment

Secondary outcomes (7)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Aug 2013

First posted9 Aug 2012 (estimated)
Study startAug 2012
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Bladder Outlet ObstructionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 395 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01661621
Sponsor's protocol ID: TCGHUROL002
Status last verified: Jun 2014
First submitted: 2 Aug 2012
Last updated: 25 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671
Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol. 2006 Apr;49(4):651-8. doi: 10.1016/j.eururo.2006.02.018. Epub 2006 Feb 17.
PubMed 16530611
Athanasopoulos A, Gyftopoulos K, Giannitsas K, Fisfis J, Perimenis P, Barbalias G. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. J Urol. 2003 Jun;169(6):2253-6. doi: 10.1097/01.ju.0000067541.73285.eb.
PubMed 12771763
Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004 Oct;94(6):817-20. doi: 10.1111/j.1464-410X.2004.05039.x.
PubMed 15476515
Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319.
PubMed 17105794
Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.
PubMed 19837435
Chung DE, Te AE, Staskin DR, Kaplan SA. Efficacy and safety of tolterodine extended release and dutasteride in male overactive bladder patients with prostates >30 grams. Urology. 2010 May;75(5):1144-8. doi: 10.1016/j.urology.2009.12.010. Epub 2010 Mar 5.
PubMed 20206978
Chung SD, Chang HC, Chiu B, Liao CH, Kuo HC. The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia. Neurourol Urodyn. 2011 Apr;30(4):568-71. doi: 10.1002/nau.20923. Epub 2011 Feb 22.
PubMed 21344494
Blake-James BT, Rashidian A, Ikeda Y, Emberton M. The role of anticholinergics in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a systematic review and meta-analysis. BJU Int. 2007 Jan;99(1):85-96. doi: 10.1111/j.1464-410X.2006.06574.x. Epub 2006 Oct 9.
PubMed 17026588
Martin-Merino E, Garcia-Rodriguez LA, Masso-Gonzalez EL, Roehrborn CG. Do oral antimuscarinic drugs carry an increased risk of acute urinary retention? J Urol. 2009 Oct;182(4):1442-8. doi: 10.1016/j.juro.2009.06.051. Epub 2009 Aug 15.
PubMed 19683302
McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
PubMed 21420124
Djavan B, Margreiter M, Dianat SS. An algorithm for medical management in male lower urinary tract symptoms. Curr Opin Urol. 2011 Jan;21(1):5-12. doi: 10.1097/MOU.0b013e32834100ef.
PubMed 21045704
Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011 Apr;65(4):487-507. doi: 10.1111/j.1742-1241.2010.02611.x. Epub 2011 Jan 7.
PubMed 21210910
Athanasopoulos A, Chapple C, Fowler C, Gratzke C, Kaplan S, Stief C, Tubaro A. The role of antimuscarinics in the management of men with symptoms of overactive bladder associated with concomitant bladder outlet obstruction: an update. Eur Urol. 2011 Jul;60(1):94-105. doi: 10.1016/j.eururo.2011.03.054. Epub 2011 Apr 9.
PubMed 21497434
Chapple C. Antimuscarinics in men with lower urinary tract symptoms suggestive of bladder outlet obstruction due to benign prostatic hyperplasia. Curr Opin Urol. 2010 Jan;20(1):43-8. doi: 10.1097/MOU.0b013e3283330862.
PubMed 19875964

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01661621
Acronym / sponsor ID: TCGHUROL002
Conditions: Bladder Outlet Obstruction
Keywords: Lower urinary tract symptoms (LUTS), International Prostate Symptom Score (IPSS), Antimuscarinics, α-blockers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 395 participants (actual)
Lead sponsor: Buddhist Tzu Chi General HospitalUniversity, hospital or other
Study start: Aug 2012
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 9 Aug 2012 (estimated)
Results: Posted 25 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

STUDY PROCEDURE

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.

1.2.1.6 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.

1.2.2.4 Check Qmax, voided volume, and PVR.

1.2.3.4 Check Qmax, voided volume, and PVR.

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:

1.3.3. 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

1.5. Prohibited medication

Patients are not allowed to take any of the following medications during the study:

Anticholinergics other than test drug
Alpha-adrenergic receptor blockers
Tricyclic anti-depressants
Calcium channel blockers
Skeletal muscle relaxant
Cyclooxygenase-2 (COX-2) inhibitors

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Drug: Detrusitol 4 mg QDAntimuscarinics (Detrusitol 4 mg QD)
Group 2	Experimental	Drug: Doxazosin 4 mg QDα-blockers (Doxazosin 4 mg QD)

Who may qualify

Ages: 40 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (12 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Detrusitol 4 mg QDGroup 1	Drug	Group 1
Doxazosin 4 mg QDGroup 2	Drug	Group 2

Primary outcome

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

7 secondary outcomes

The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day
Time frame: Baseline and 1 month
The Maximum Flow Rate (Qmax) After the Treatment Day
Time frame: Baseline and 1 month
The Voided Volume After the Treatment Day
Time frame: Baseline and 1 month
The Postvoid Residual Volume (PVR) After the Treatment Day
Time frame: Baseline and 1 month
The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day
Time frame: Baseline and 1 month
The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day
Time frame: 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

Results and safety

Results posted to the registry on 25 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	116	116
Group 2	279	279

Primary outcome: The Global Response Assessment (GRA) After the Treatment Day

Time frame: 1 month after initial treatment. Number. Unit: participants

Measure	Group 1 n = 116	Group 2 n = 279
GRA≥1	89	218
GRA<1	27	61

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 116 (0%)	18 of 116 (15.5%)	Not reported
Group 2	0 of 279 (0%)	33 of 279 (11.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
Background: PubMed 16530611Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol. 2006 Apr;49(4):651-8. doi: 10.1016/j.eururo.2006.02.018. Epub 2006 Feb 17.
Background: PubMed 12771763Athanasopoulos A, Gyftopoulos K, Giannitsas K, Fisfis J, Perimenis P, Barbalias G. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. J Urol. 2003 Jun;169(6):2253-6. doi: 10.1097/01.ju.0000067541.73285.eb.
Background: PubMed 15476515Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004 Oct;94(6):817-20. doi: 10.1111/j.1464-410X.2004.05039.x.
Background: PubMed 17105794Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319.
Background: PubMed 19837435Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W. Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency. J Urol. 2009 Dec;182(6):2825-30. doi: 10.1016/j.juro.2009.08.023. Epub 2009 Oct 17.
Background: PubMed 20206978Chung DE, Te AE, Staskin DR, Kaplan SA. Efficacy and safety of tolterodine extended release and dutasteride in male overactive bladder patients with prostates >30 grams. Urology. 2010 May;75(5):1144-8. doi: 10.1016/j.urology.2009.12.010. Epub 2010 Mar 5.
Background: PubMed 21344494Chung SD, Chang HC, Chiu B, Liao CH, Kuo HC. The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia. Neurourol Urodyn. 2011 Apr;30(4):568-71. doi: 10.1002/nau.20923. Epub 2011 Feb 22.
Background: PubMed 17026588Blake-James BT, Rashidian A, Ikeda Y, Emberton M. The role of anticholinergics in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a systematic review and meta-analysis. BJU Int. 2007 Jan;99(1):85-96. doi: 10.1111/j.1464-410X.2006.06574.x. Epub 2006 Oct 9.
Background: PubMed 19683302Martin-Merino E, Garcia-Rodriguez LA, Masso-Gonzalez EL, Roehrborn CG. Do oral antimuscarinic drugs carry an increased risk of acute urinary retention? J Urol. 2009 Oct;182(4):1442-8. doi: 10.1016/j.juro.2009.06.051. Epub 2009 Aug 15.
Background: PubMed 21420124McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
Background: PubMed 21045704Djavan B, Margreiter M, Dianat SS. An algorithm for medical management in male lower urinary tract symptoms. Curr Opin Urol. 2011 Jan;21(1):5-12. doi: 10.1097/MOU.0b013e32834100ef.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hann-Chorng Kuo, M.D. principal investigator

Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Detrusitol 4 mg QD and Doxazosin 4 mg QD in people with Bladder Outlet Obstruction, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Global Response Assessment (GRA) After the Treatment Day (time frame: 1 month after initial treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01661621, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2014.