Comparisons of 3-month Versus 6-month Solifenacin Treatment for Female OAB Patients

National Taiwan University

Status and phase: Unknown; Phase 4

Conditions: Overactive Bladder Syndrome

Treatments: Drug: Solifenacin for 24 weeks; Drug: Solifenacin for 12 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT01876186

201212143RINB

Details and patient eligibility

About

To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.

Full description

Overactive bladder syndrome (OAB), with or without urge incontinence, is characterized by urinary urgency, frequency and nocturia. Thus, patients with OAB could be considered to have a reduced quality of life. Patients with overactive bladder syndrome have a higher risk of falling and fracture due to nocturia. OAB affects around 17 % of female population. At present, muscarinic receptor antagonists are the first-line pharmacotherapeutic agents for OAB. However, discontinuation of the treatment often results in symptom relapse. Until now, optimal duration of the treatment and durability of the efficacy have not been determined. We plan to use urodynamic studies outcome to evaluate therapeutic effect, with the change of urinary nerve growth factor level. This study is a randomized prospective study, comparing female OAB patient after 3 months and 6 months of antimuscarinic treatment.

The purpose of this study is to investigate the difference of urodynamic effects, therapeutic effect and urinary urinary nerve growth factor level between OAB females after 3 months and 6 months antimuscarinic treatment.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who have overactive bladder syndrome

Exclusion criteria

• Women who are less than 20 year-old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Solifenacin for 12 weeks group

Experimental group

Description:

Solifenacin (5 mg qd) for 12 weeks

Treatment:

Drug: Solifenacin for 12 weeks

Solifenacin for 24 weeks group

Active Comparator group

Description:

Solifenacin (5 mg qd) for 24 weeks

Treatment:

Drug: Solifenacin for 24 weeks