Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Comparison of Oxybutynin and Solifenacin in the Treatment of Overactive Bladder: a Randomized Controlled Multicenter Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01423838

Enrollment

500

Registered

2011-08-26

Start date

2011-09-30

Completion date

2012-09-30

Last updated

2011-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Overactive bladder, Solifenacin, Oxybutynin

Brief 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.

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.

Interventions

DRUGSolifenacin

5 mg, oral, once in a day

DRUGOxybutynin

5 mg, oral, three times in a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame	Description
Degree of improvement in overactive bladder symptoms	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.

Secondary

Measure	Time frame	Description
To compare the degree of side effects between two study groups	2 months	Outcome measures will be compliance to the study drugs, patient satisfaction, willingness to continue treatment, degree of side effects.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMurat Api, M.D., PhD.

muratapi@hotmail.com+905424241807

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026