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Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

A

Adana Numune Training and Research Hospital

Status and phase

Unknown
Phase 4

Conditions

Overactive Bladder

Treatments

Drug: Solifenacin
Drug: Oxybutynin

Study type

Interventional

Funder types

Other

Identifiers

NCT01423838
Solifenacin vs Oxybutynin

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

Solifenacin
Active Comparator group
Description:
Anticholinergic molecule used in the treatment of overactive bladder.
Treatment:
Drug: Solifenacin
Oxybutynin
Active Comparator group
Description:
Anticholinergic molecule used in the treatment of overactive bladder.
Treatment:
Drug: Oxybutynin

Trial contacts and locations

1

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Central trial contact

Murat Api, M.D., PhD.

Data sourced from clinicaltrials.gov

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