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| Name | Class |
|---|---|
| Recalcine (GynoPharm) | UNKNOWN |
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Overactive bladder is a common problem among adult women. Darifenacin is an antimuscarinic drug that is frequently used as part of the management of the condition. However, current evidence backing its use is limited. This study aims to address Darifenacin's effectiveness in adjunct to physiotherapy in treating symptoms due to overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darifenacin + Physiotherapy | Experimental | Patients allocated to this group will receive Darifenacin 7.5mg daily in addition to physiotherapy for 12 weeks. This dose may be increased up to 7.5mg twice daily in follow-up visits in cases of refractory symptoms. |
|
| Physiotherapy | Active Comparator | Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darifenacin | Drug | Darifenacin will be prescribed in a starting dose of 7.5mg, once daily. This dose may be increased to 15mg a day in cases with refractory symptoms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Overall quality of life as established by the Overactive Bladder Questionnaire. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overactive Bladder Symptoms | Presence of symptoms of overactive bladder, as established by the King's Health Questionnaire and the International Consultation on Incontinence Questionnaire. | 12 weeks |
| Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Cifuentes, M.D. | Senior Urologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Carlos Van Buren | ValparaÃso | Valparaiso | 2341131 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37160401 | Derived | Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3. |
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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 |
|---|---|
| C101207 | darifenacin |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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|
| Physiotherapy | Procedure | All patients will received a tailored pelvic floor exercise programme as part of the standard of care of overactive bladder at the study centre. This intervention will be mainly comprised of biofeedback stimulation techniques. |
|
Development of any adverse event attributable to darifenacin and as established by a standardised questionnaire.
| 12 weeks |
| 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 |