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

Primary Purpose

Overactive Bladder Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Solifenacin for 12 weeks
Solifenacin for 24 weeks
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder Syndrome focused on measuring antimuscarinic treatment, urodynamic studies, nerve growth factor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women who have overactive bladder syndrome

Exclusion Criteria:

  • Women who are less than 20 year-old

Sites / Locations

  • Department of Obstetrics & Gynecology, National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Solifenacin for 12 weeks group

Solifenacin for 24 weeks group

Arm Description

Solifenacin (5 mg qd) for 12 weeks

Solifenacin (5 mg qd) for 24 weeks

Outcomes

Primary Outcome Measures

The rate of normalized urodynamic findings
The rate of normalized urodynamic finding after antimuscarinics

Secondary Outcome Measures

The cure rate of overactive bladder
The cure rate of overactive bladder after antimuscarinics
The recurrence rate of overactive bladder
The recurrence rate of overactive bladder after antimuscarinics
The difference of urine nerve growth factor level
The difference of urine nerve growth factor level after antimuscarinics

Full Information

First Posted
June 10, 2013
Last Updated
July 5, 2015
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01876186
Brief Title
Comparisons of 3-month Versus 6-month Solifenacin Treatment for Female OAB Patients
Official Title
Comparisons of Urodynamic Effects, Urinary Nerve Growth Factor Levels and Outcomes in Female Overactive Bladder Patients After 3-month Versus 6-month Solifenacin Treatment: a Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder Syndrome
Keywords
antimuscarinic treatment, urodynamic studies, nerve growth factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Solifenacin for 12 weeks group
Arm Type
Experimental
Arm Description
Solifenacin (5 mg qd) for 12 weeks
Arm Title
Solifenacin for 24 weeks group
Arm Type
Active Comparator
Arm Description
Solifenacin (5 mg qd) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Solifenacin for 12 weeks
Other Intervention Name(s)
Vesicare
Intervention Description
Solifenacin 5 mg one a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Solifenacin for 24 weeks
Other Intervention Name(s)
Vesicare
Intervention Description
Solifenacin 5 mg once a day for 24 weeks
Primary Outcome Measure Information:
Title
The rate of normalized urodynamic findings
Description
The rate of normalized urodynamic finding after antimuscarinics
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The cure rate of overactive bladder
Description
The cure rate of overactive bladder after antimuscarinics
Time Frame
24 weeks
Title
The recurrence rate of overactive bladder
Description
The recurrence rate of overactive bladder after antimuscarinics
Time Frame
2.5 years
Title
The difference of urine nerve growth factor level
Description
The difference of urine nerve growth factor level after antimuscarinics
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who have overactive bladder syndrome Exclusion Criteria: Women who are less than 20 year-old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho-Hsiung Lin, MD, PhD
Phone
+886-2-23123456
Ext
71557
Email
hhlin@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Hsiung Lin, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics & Gynecology, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho-Hsiung Lin, MD, PhD
Phone
+886-2-23123456
Ext
71557
Email
hhlin@ntuh.gov.tw
First Name & Middle Initial & Last Name & Degree
Ho-Hsiung Lin, MD, PhD

12. IPD Sharing Statement

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

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