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

NCT ID: NCT01876186

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-12-31

Brief Summary

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

Detailed 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.

Conditions

Overactive Bladder Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Solifenacin for 12 weeks group

Solifenacin (5 mg qd) for 12 weeks

Group Type: EXPERIMENTAL

Solifenacin for 12 weeks

Intervention Type: DRUG

Solifenacin 5 mg one a day for 12 weeks

Solifenacin for 24 weeks group

Solifenacin (5 mg qd) for 24 weeks

Group Type: ACTIVE_COMPARATOR

Solifenacin for 24 weeks

Intervention Type: DRUG

Solifenacin 5 mg once a day for 24 weeks

Interventions

Solifenacin for 12 weeks

Solifenacin 5 mg one a day for 12 weeks

Intervention Type: DRUG

Solifenacin for 24 weeks

Solifenacin 5 mg once a day for 24 weeks

Intervention Type: DRUG

Other Intervention Names

Vesicare; Vesicare

Eligibility Criteria

Inclusion Criteria

• Women who have overactive bladder syndrome

Exclusion Criteria

• Women who are less than 20 year-old

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ho-Hsiung Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Department of Obstetrics & Gynecology, National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ho-Hsiung Lin, MD, PhD

Role: CONTACT

hhlin@ntuh.gov.tw

+886-2-23123456 ext. 71557

Facility Contacts

Ho-Hsiung Lin, MD, PhD

Role: primary

hhlin@ntuh.gov.tw

+886-2-23123456 ext. 71557

Other Identifiers

201212143RINB

Identifier Type: -

Identifier Source: org_study_id