Overactive BladderPhase 4NCT01824420
Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome
A Phase 4 study testing Detrusitol 4mg QD and Oxybutynin ER 5mg QD and Detrusitol 4mg QD in people with Overactive Bladder, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
To investigate if oxybutynin ER adding on antimuscarinics is more effective than mono-antimuscarinic treatment for patients with refractory OAB Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Detrusitol 4mg QD and Oxybutynin ER 5mg QD and Detrusitol 4mg QD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥20 years of male or female gender with OAB refractory to one antimuscarinics therapy
- Patient or his/her legally acceptable representative has signed the written informed consent form
Who cannot join
- Patients with untreated bladder outlet obstruction, intrinsic sphincter deficiency, pelvic organ prolapse
- Patients with history of urethral injury or transurethral surgery for prostate or bladder
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patients with known active urinary tract infection, urinary stone or malignancy
- 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 urinary retention, PVR≥250 ml
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome - A Prospective Randomized Controlled Comparative Study With Mono-antimuscarinic Therapy
To investigate if oxybutynin ER adding on antimuscarinics is more effective than mono-antimuscarinic treatment for patients with refractory OAB
Read the detailed description
- Introduction:Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urgency incontinence. Usually no metabolic or anatomical disorders can be found in patients with OAB, and the condition may have a great impact on quality of life. Antimuscarinics are the first line treatment and yield a success rate of more than 70%. Urothelial dysfunction and abnormalities of sensory receptor expression or transmitter release in the suburothelial nerves might contribute to OAB which is refractory to antimuscarinics. In patients who failed current antimuscarinic treatment, intravesical botulinum toxin A (BoNT-A) injection provides an chance of improvement. Previous studies reported success rates of BoNT-A injection for OAB ranged from 60 to 80%. Intravesical treatment to inhibit abnormal receptor expression or transmitter release in the sensory nerve terminals of the suburothelial space can provide good therapeutic effects in the treatment of OAB. However, patients might develop large postvoid residual (PVR) and subsequent urinary tract infection (UTI) after BoNT-A injections, therefore, this treatment is usually left for patients who are refractory to antimuscarinic therapy. However, how to define antimuscarinic refractory OAB remains controversial. How many different types of antimuscarinics should be prescribed before we call the case failure has not been elucidated. The aim of this study is to evaluate the effect of flexibly adding-on oxybutynin ER (5mg QD) in patients with OAB who were refractory to monotherapy with the first antimuscarinic agent (tolterodine 4mg QD).
- Methods: A total of 200 patients with refractory OAB will be included in this prospective, open label protocol. Inclusion criteria are persistent OAB symptoms (frequency urgency with/without urgency urinary incontinence) after behaviour therapy and an optimized dose of one antimuscarinic agent (Tolterodine 4mg) for at least 3 months. Patients with neurogenic diseases, untreated bladder outlet obstruction, recurrent UTI, large PVR (>150ml) will be excluded from this study. Patients will be randomized to allocate in the treatment group (receiving tolterodine 4mg QD and oxybutynin 5mg to 15mg QD) or control group (tolterodine 4mg QD) in 1:1 ratio based on the permuted block randomization code. Oxybutynin ER 5mg to 15 mg once daily will be flexibly adding-on from baseline to the third month in the treatment group, depending on patient's effectiveness and tolerability to adverse events. At the baseline, 1 and 3 months after oxybutynin ER adding-on, we will assess the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), Patient Perception of Bladder Condition (PPBC), the Urgency Severity Scale (USS) questionnaires, uroflowmetry and PVR. The therapeutic effect will be considered as successful if there was a reduction of PPBC of 2 from baseline and a reduction of USS of 1 from baseline, or the USS value is 0 at 3 months. The adverse events and tolerability of this combined therapy will also be assessed.
- Expected Results: Compared with baseline, total IPSS, IPSS storage subscore, quality of life indexes, OABSS, USS and PPBC will be expected to significantly decrease at 1 and 3 months. PVR might be increased at 3 months after adding-on treatment. The changes of IPSS voiding subscore, peak urinary flow rate and voided volume might be increased or comparable to the control group during the follow-up. We expect at least one-third of patients can have a successful therapeutic effect without significantly increased adverse events. However, the other patients might withdraw from the study due to adverse events such as severe dry mouth, constipation, large PVR, UTI, severe difficult urination or acute urinary retention.
Adverse events should be cautiously monitored during the treatment course.
- Conditions
- Overactive Bladder
- Being tested
- Detrusitol 4mg QD and Oxybutynin ER 5mg QD, Detrusitol 4mg QD
- Keywords
- Refractory overactive bladder syndrome, Antimuscarinic agent
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detrusitol 4mg QD and Oxybutynin ER 5mg QDDrug
Also called Tolterodine (Detrusitol) 4mg QD, Oxybutynin (Ditropan) ER 5mg QD
Study group
Detrusitol 4mg QDDrug
Also called Tolterodine (Detrusitol) 4mg QD
Control group
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Tolterodine (Detrusitol) 4mg QD and Oxybutynin (Ditropan) ER 5mg QD Receives: Drug: Detrusitol 4mg QD and Oxybutynin ER 5mg QD |
| Control group | Experimental | Tolterodine (Detrusitol) 4mg QD Receives: Drug: Detrusitol 4mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points
Efficacy:
Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points (1 month, 2 months and 3 months). If patients have a PPBC improved by two scales, they are considered as successfully treated, otherwise failed treatment.
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Secondary outcomes (8)
Change from Baseline in the Overactive Bladder Symptom Score (OABSS) at different time points
Efficacy:
Change from Baseline in the Overactive Bladder Symptom Score (OABSS) at different time points (1 month, 2 months and 3 months).
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Change from Baseline in the urinary sensation scale (USS) at different time points
Efficacy:
Change from Baseline in the urinary sensation scale (USS) at different time points (1 month, 2 months and 3 months).
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Change from Baseline in the International Prostate Symptom Score (IPSS) at different time points
Efficacy:
Change from Baseline in the International Prostate Symptom Score (IPSS) at different time points (1 month, 2 months and 3 months).
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Change from Baseline in the maximum flow rate (Qmax) at different time points
Efficacy:
Change from Baseline in the maximum flow rate (Qmax) at different time points (1 month, 2 months and 3 months).
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Change from Baseline in the voided volume at different time points
Efficacy:
Change from Baseline in the voided volume at different time points (1 month, 2 months and 3 months).
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Change from Baseline in the postvoid residual volume (PVR) at different time points
Efficacy:
Change from Baseline in the postvoid residual volume (PVR) at different time points (1 month, 2 months and 3 months).
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Change from Baseline in the total prostate volume (TPV) at different time points
Efficacy:
Change from Baseline in the total prostate volume (TPV) at different time points (1 month, 2 months and 3 months) are evaluated in men
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Change from Baseline in the transition zone index (TZI) at different time points
Efficacy:
Change from Baseline in the transition zone index (TZI) at different time points (1 month, 2 months and 3 months) are evaluated in men
Safety:
Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
Measured: 1 month, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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
- Model description
- Prospective, open-label study. The overactive bladder patients maintained their previous antimuscarinic medication and we flexibly added on the second antimuscarinic drug (oxybutynin ER 5 mg QD) or not.
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital
- Investigators
- Hann-Chorng Kuo, M.D., Principal investigator, Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824420
- Sponsor's protocol ID
- TCGHUROL008
- Status last verified
- Mar 2017
- First submitted
- 1 Apr 2013
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD cannot be released unless approval by the Ethics Committee of the Buddhist Tzu Chi General Hospital, Hualien, Taiwan
Publications
Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000 Jul;6(11 Suppl):S580-90.
PubMed 11183901Chapple CR. Muscarinic receptor antagonists in the treatment of overactive bladder. Urology. 2000 May;55(5A Suppl):33-46; discussion 50. doi: 10.1016/s0090-4295(99)00492-6.
PubMed 10767450Yiangou Y, Facer P, Ford A, Brady C, Wiseman O, Fowler CJ, Anand P. Capsaicin receptor VR1 and ATP-gated ion channel P2X3 in human urinary bladder. BJU Int. 2001 Jun;87(9):774-9. doi: 10.1046/j.1464-410x.2001.02190.x.
PubMed 11412212Apostolidis A, Popat R, Yiangou Y, Cockayne D, Ford AP, Davis JB, Dasgupta P, Fowler CJ, Anand P. Decreased sensory receptors P2X3 and TRPV1 in suburothelial nerve fibers following intradetrusor injections of botulinum toxin for human detrusor overactivity. J Urol. 2005 Sep;174(3):977-82; discussion 982-3. doi: 10.1097/01.ju.0000169481.42259.54.
PubMed 16094018Simpson LL. Kinetic studies on the interaction between botulinum toxin type A and the cholinergic neuromuscular junction. J Pharmacol Exp Ther. 1980 Jan;212(1):16-21.
PubMed 6243359Kuo HC. Urodynamic evidence of effectiveness of botulinum A toxin injection in treatment of detrusor overactivity refractory to anticholinergic agents. Urology. 2004 May;63(5):868-72. doi: 10.1016/j.urology.2003.12.007.
PubMed 15134967Kuo HC. Comparison of effectiveness of detrusor, suburothelial and bladder base injections of botulinum toxin a for idiopathic detrusor overactivity. J Urol. 2007 Oct;178(4 Pt 1):1359-63. doi: 10.1016/j.juro.2007.05.136. Epub 2007 Aug 16.
PubMed 17706718
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome - A Prospective Randomized Controlled Comparative Study With Mono-antimuscarinic Therapy
- ClinicalTrials.gov ID
- NCT01824420
- Acronym / sponsor ID
- TCGHUROL008
- Conditions
- Overactive Bladder
- Keywords
- Refractory overactive bladder syndrome, Antimuscarinic agent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate if oxybutynin ER adding on antimuscarinics is more effective than mono-antimuscarinic treatment for patients with refractory OAB
Detailed description
- Introduction:Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urgency incontinence. Usually no metabolic or anatomical disorders can be found in patients with OAB, and the condition may have a great impact on quality of life. Antimuscarinics are the first line treatment and yield a success rate of more than 70%. Urothelial dysfunction and abnormalities of sensory receptor expression or transmitter release in the suburothelial nerves might contribute to OAB which is refractory to antimuscarinics. In patients who failed current antimuscarinic treatment, intravesical botulinum toxin A (BoNT-A) injection provides an chance of improvement. Previous studies reported success rates of BoNT-A injection for OAB ranged from 60 to 80%. Intravesical treatment to inhibit abnormal receptor expression or transmitter release in the sensory nerve terminals of the suburothelial space can provide good therapeutic effects in the treatment of OAB. However, patients might develop large postvoid residual (PVR) and subsequent urinary tract infection (UTI) after BoNT-A injections, therefore, this treatment is usually left for patients who are refractory to antimuscarinic therapy. However, how to define antimuscarinic refractory OAB remains controversial. How many different types of antimuscarinics should be prescribed before we call the case failure has not been elucidated. The aim of this study is to evaluate the effect of flexibly adding-on oxybutynin ER (5mg QD) in patients with OAB who were refractory to monotherapy with the first antimuscarinic agent (tolterodine 4mg QD).
- Methods: A total of 200 patients with refractory OAB will be included in this prospective, open label protocol. Inclusion criteria are persistent OAB symptoms (frequency urgency with/without urgency urinary incontinence) after behaviour therapy and an optimized dose of one antimuscarinic agent (Tolterodine 4mg) for at least 3 months. Patients with neurogenic diseases, untreated bladder outlet obstruction, recurrent UTI, large PVR (>150ml) will be excluded from this study. Patients will be randomized to allocate in the treatment group (receiving tolterodine 4mg QD and oxybutynin 5mg to 15mg QD) or control group (tolterodine 4mg QD) in 1:1 ratio based on the permuted block randomization code. Oxybutynin ER 5mg to 15 mg once daily will be flexibly adding-on from baseline to the third month in the treatment group, depending on patient's effectiveness and tolerability to adverse events. At the baseline, 1 and 3 months after oxybutynin ER adding-on, we will assess the International Prostate Symptom Score (IPSS), Overactive Bladder Symptom Score (OABSS), Patient Perception of Bladder Condition (PPBC), the Urgency Severity Scale (USS) questionnaires, uroflowmetry and PVR. The therapeutic effect will be considered as successful if there was a reduction of PPBC of 2 from baseline and a reduction of USS of 1 from baseline, or the USS value is 0 at 3 months. The adverse events and tolerability of this combined therapy will also be assessed.
- Expected Results: Compared with baseline, total IPSS, IPSS storage subscore, quality of life indexes, OABSS, USS and PPBC will be expected to significantly decrease at 1 and 3 months. PVR might be increased at 3 months after adding-on treatment. The changes of IPSS voiding subscore, peak urinary flow rate and voided volume might be increased or comparable to the control group during the follow-up. We expect at least one-third of patients can have a successful therapeutic effect without significantly increased adverse events. However, the other patients might withdraw from the study due to adverse events such as severe dry mouth, constipation, large PVR, UTI, severe difficult urination or acute urinary retention.
Adverse events should be cautiously monitored during the treatment course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open-label study. The overactive bladder patients maintained their previous antimuscarinic medication and we flexibly added on the second antimuscarinic drug (oxybutynin ER 5 mg QD) or not.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Detrusitol 4mg QD and Oxybutynin ER 5mg QDTolterodine (Detrusitol) 4mg QD and Oxybutynin (Ditropan) ER 5mg QD |
| Control group | Experimental | Drug: Detrusitol 4mg QDTolterodine (Detrusitol) 4mg QD |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged ≥20 years of male or female gender with OAB refractory to one antimuscarinics therapy
- Patient or his/her legally acceptable representative has signed the written informed consent form
Key exclusion criteria (12 listed)
- Patients with untreated bladder outlet obstruction, intrinsic sphincter deficiency, pelvic organ prolapse
- Patients with history of urethral injury or transurethral surgery for prostate or bladder
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patients with known active urinary tract infection, urinary stone or malignancy
- 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 4mg QD and Oxybutynin ER 5mg QDAlso: Tolterodine (Detrusitol) 4mg QD, Oxybutynin (Ditropan) ER 5mg QDStudy group | Drug | Study group |
| Detrusitol 4mg QDAlso: Tolterodine (Detrusitol) 4mg QDControl group | Drug | Control group |
Primary outcome
Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points
Time frame: 1 month, 2 months and 3 months
Efficacy: Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points (1 month, 2 months and 3 months). If patients have a PPBC improved by two scales, they are considered as successfully treated, otherwise failed treatment. Safety: Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
8 secondary outcomes
Change from Baseline in the Overactive Bladder Symptom Score (OABSS) at different time points
Time frame: 1 month, 2 months and 3 months
Change from Baseline in the urinary sensation scale (USS) at different time points
Time frame: 1 month, 2 months and 3 months
Change from Baseline in the International Prostate Symptom Score (IPSS) at different time points
Time frame: 1 month, 2 months and 3 months
Change from Baseline in the maximum flow rate (Qmax) at different time points
Time frame: 1 month, 2 months and 3 months
Change from Baseline in the voided volume at different time points
Time frame: 1 month, 2 months and 3 months
Change from Baseline in the postvoid residual volume (PVR) at different time points
Time frame: 1 month, 2 months and 3 months
Change from Baseline in the total prostate volume (TPV) at different time points
Time frame: 1 month, 2 months and 3 months
Change from Baseline in the transition zone index (TZI) at different time points
Time frame: 1 month, 2 months and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Background: PubMed 11183901Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000 Jul;6(11 Suppl):S580-90.
- Background: PubMed 10767450Chapple CR. Muscarinic receptor antagonists in the treatment of overactive bladder. Urology. 2000 May;55(5A Suppl):33-46; discussion 50. doi: 10.1016/s0090-4295(99)00492-6.
- Background: PubMed 11412212Yiangou Y, Facer P, Ford A, Brady C, Wiseman O, Fowler CJ, Anand P. Capsaicin receptor VR1 and ATP-gated ion channel P2X3 in human urinary bladder. BJU Int. 2001 Jun;87(9):774-9. doi: 10.1046/j.1464-410x.2001.02190.x.
- Background: PubMed 16094018Apostolidis A, Popat R, Yiangou Y, Cockayne D, Ford AP, Davis JB, Dasgupta P, Fowler CJ, Anand P. Decreased sensory receptors P2X3 and TRPV1 in suburothelial nerve fibers following intradetrusor injections of botulinum toxin for human detrusor overactivity. J Urol. 2005 Sep;174(3):977-82; discussion 982-3. doi: 10.1097/01.ju.0000169481.42259.54.
- Background: PubMed 6243359Simpson LL. Kinetic studies on the interaction between botulinum toxin type A and the cholinergic neuromuscular junction. J Pharmacol Exp Ther. 1980 Jan;212(1):16-21.
- Background: PubMed 15134967Kuo HC. Urodynamic evidence of effectiveness of botulinum A toxin injection in treatment of detrusor overactivity refractory to anticholinergic agents. Urology. 2004 May;63(5):868-72. doi: 10.1016/j.urology.2003.12.007.
- Background: PubMed 17706718Kuo HC. Comparison of effectiveness of detrusor, suburothelial and bladder base injections of botulinum toxin a for idiopathic detrusor overactivity. J Urol. 2007 Oct;178(4 Pt 1):1359-63. doi: 10.1016/j.juro.2007.05.136. Epub 2007 Aug 16.
- Individual participant dataSharing planned: No. IPD cannot be released unless approval by the Ethics Committee of the Buddhist Tzu Chi General Hospital, Hualien, Taiwan
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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 4mg QD and Oxybutynin ER 5mg QD and Detrusitol 4mg QD in people with Overactive Bladder, 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 8 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points (time frame: 1 month, 2 months and 3 months). 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 NCT01824420, which also lists 7 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 8 Mar 2017.