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

Overactive Bladder Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01876186
• Other study ID #: 201212143RINB
• Status: Recruiting
• Phase: Phase 4
• First received: June 10, 2013
• Last updated: July 5, 2015
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: National Taiwan University Hospital
• Contact: Ho-Hsiung Lin, MD, PhD
• Phone: +886-2-23123456
• Email: hhlin[@]ntuh.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Women who have overactive bladder syndrome

Exclusion Criteria:

• Women who are less than 20 year-old

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin for 12 weeks
Solifenacin 5 mg one a day for 12 weeks
• Solifenacin for 24 weeks
Solifenacin 5 mg once a day for 24 weeks

Locations

Country	Name	City	State
Taiwan	Department of Obstetrics & Gynecology, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of normalized urodynamic findings	The rate of normalized urodynamic finding after antimuscarinics	6 months	No
Secondary	The cure rate of overactive bladder	The cure rate of overactive bladder after antimuscarinics	24 weeks	No
Secondary	The recurrence rate of overactive bladder	The recurrence rate of overactive bladder after antimuscarinics	2.5 years	No
Secondary	The difference of urine nerve growth factor level	The difference of urine nerve growth factor level after antimuscarinics	24 weeks	No