Overactive BladderPhase 4NCT01423838
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
A Phase 4 study testing Solifenacin and Oxybutynin in people with Overactive Bladder, run by Adana Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Null hypothesis of the trial is that there is no difference between solifenacin and oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life measures in patients with overactive bladder. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin and Oxybutynin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2011to Sep 2012
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Women between 18-70 years of age, diagnosed to have overactive bladder (presence of at least two of the following three main criteria: urgency, urge incontinence, frequency and nocturia)
Exclusion Criteria: Presence of stress urinary incontinence, patients who are still using a drug for overactive bladder, pregnant women, women in postpartum period (women on lactation), patients who have closed angle glaucoma, patients with chronic constipation, having allergy to the ingredients of the drugs, patients having the contraindicated conditions listed in the printed instructions of the drugs.
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Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
Adana, 01150
Murat Api, M.D., Ph.D., +905424241807, muratapi@hotmail.com
Hakan Aytan, M.D., +905056833866, drhakanaytan@yahoo.com
About this study
Official title: Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial
Null hypothesis of the trial is that there is no difference between solifenacin and oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life measures in patients with overactive bladder.
Read the detailed description
In this two-month follow-up study, the patients with overactive bladder will be randomly assigned into two groups (solifenacin or oxybutynin in their usual doses) and will be assessed with respect to baseline characteristics and complaints before treatment. After initiation of the treatment at first and second months follow-up visits the patients will be reassessed with respect to compliance, satisfaction, degree of improvement, reasons for dropouts, number and severity of side effects.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin, Oxybutynin
- Keywords
- Overactive bladder, Solifenacin, Oxybutynin
- 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.
SolifenacinDrug
Also called Kinzy
5 mg, oral, once in a day
OxybutyninDrug
Also called Uropan
5 mg, oral, three times in a day
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin | Active comparator | Anticholinergic molecule used in the treatment of overactive bladder. Receives: Drug: Solifenacin |
| Oxybutynin | Active comparator | Anticholinergic molecule used in the treatment of overactive bladder. Receives: Drug: Oxybutynin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of improvement in overactive bladder symptoms
The main symptoms of overactive bladder are frequency, urgency, urge incontinence and nocturia (if any). The primary outcome of the trial will be comparison of the improvement of these symptoms in terms of number and severity between two study groups.
Measured: 2 months
Secondary outcomes (1)
To compare the degree of side effects between two study groups
Outcome measures will be compliance to the study drugs, patient satisfaction, willingness to continue treatment, degree of side effects.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adana Numune Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Kocaeli University, Akdeniz University, Cukurova University, Baskent University, Ankara University, University of Gaziantep, Inonu University, Gaziosmanpasa University, Kahramanmaras Sutcu Imam University
- Responsible party
- Principal investigator, Murat Api, Adana Numune Training and Research Hospital
- Investigators
- Murat Api, M.D., Ph.D., Study director, Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423838
- Sponsor's protocol ID
- Solifenacin vs Oxybutynin
- Status last verified
- Aug 2011
- First submitted
- 25 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT01423838
- Acronym / sponsor ID
- Solifenacin vs Oxybutynin
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Solifenacin, Oxybutynin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Adana Numune Training and Research HospitalOther government
- Collaborators
- Kocaeli University, Akdeniz University, Cukurova University, Baskent University, Ankara University, University of Gaziantep, Inonu University, Gaziosmanpasa University, Kahramanmaras Sutcu Imam University
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 26 Aug 2011 (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.
Null hypothesis of the trial is that there is no difference between solifenacin and oxybutynin with respect to efficacy, side effects, patient satisfaction and quality of life measures in patients with overactive bladder.
Detailed description
In this two-month follow-up study, the patients with overactive bladder will be randomly assigned into two groups (solifenacin or oxybutynin in their usual doses) and will be assessed with respect to baseline characteristics and complaints before treatment. After initiation of the treatment at first and second months follow-up visits the patients will be reassessed with respect to compliance, satisfaction, degree of improvement, reasons for dropouts, number and severity of side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solifenacin | Active comparator | Drug: SolifenacinAnticholinergic molecule used in the treatment of overactive bladder. |
| Oxybutynin | Active comparator | Drug: OxybutyninAnticholinergic molecule used in the treatment of overactive bladder. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SolifenacinAlso: Kinzy5 mg, oral, once in a day | Drug | Solifenacin |
| OxybutyninAlso: Uropan5 mg, oral, three times in a day | Drug | Oxybutynin |
Primary outcome
Degree of improvement in overactive bladder symptoms
Time frame: 2 months
The main symptoms of overactive bladder are frequency, urgency, urge incontinence and nocturia (if any). The primary outcome of the trial will be comparison of the improvement of these symptoms in terms of number and severity between two study groups.
1 secondary outcome
To compare the degree of side effects between two study groups
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
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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.
Murat Api, M.D., Ph.D. study director
Turkish Republic Ministry of Health Adana Numune Training and Research Hospital
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 Solifenacin and Oxybutynin in people with Overactive Bladder, run by Adana Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Aug 2011. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Murat Api, M.D., PhD. (+905424241807, muratapi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of improvement in overactive bladder symptoms (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2011.