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| Name | Class |
|---|---|
| Kocaeli University | OTHER |
| Akdeniz University | OTHER |
| Cukurova University | OTHER |
| Baskent University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solifenacin | Active Comparator | Anticholinergic molecule used in the treatment of overactive bladder. |
|
| Oxybutynin | Active Comparator | Anticholinergic molecule used in the treatment of overactive bladder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin | Drug | 5 mg, oral, once in a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Murat Api, M.D., PhD. | Contact | +905424241807 | muratapi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Murat Api, M.D., Ph.D. | Turkish Republic Ministry of Health Adana Numune Training and Research Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turkish Republic Ministry of Health Adana Numune Training and Research Hospital | Adana | 01150 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| C005419 | oxybutynin |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| OTHER |
| Ankara University | OTHER |
| University of Gaziantep | OTHER |
| Inonu University | OTHER |
| Gaziosmanpasa University | UNKNOWN |
| Kahramanmaras Sutcu Imam University | OTHER |
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| Oxybutynin | Drug | 5 mg, oral, three times in a day |
|
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |