Predictors for Retreatement of OAB After DC Mirabegron

Recurrence of Overactive Bladder Syndrome Clinical Trial

Official title:

Predictor for Re-treatment of Overactive Bladder Syndrome After Discontinuation of Mirabegron Treatment for Female Overactive Bladder Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550702
• Other study ID #: 202006091RIND
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: July 31, 2019

Study information

• Verified date: July 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recurrence of female overactive bladder syndrome (OAB) is not uncommon. It is important to decrease the recurrence of female OAB. However, factors predicting recurrence of female OAB, especially for those women who need retreatment is undetermined. Thus, the aim of this study was to elucidate factors predicting retreatment of female OAB.

Description:

The medical records, including pad testing, urodynamic studies, lower urinary tract symptoms related questionnaires and bladder diaries of all consecutive women with OAB, who visited urogynecologic clinics in a tertiary referral center, were reviewed. Persistence interval was defined from the date of prescription of mirabegron to the date of discontinuation of mirabegron treatment. Statistical analysis was performed with Kaplan-Meier estimator. Multivariable Cox proportional-hazard model with all variables with p < 0.25 in the univariate analysis was performed to predict OAB retreatment probability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• Women with overactive bladder syndrome

• Women complete urodynamic study and bladder diary

Exclusion Criteria:

• Pregnant women

• Incomplete data

• Loss of follow-up

• Acute or chronic urinary tract infection

Related Conditions & MeSH terms

• Recurrence
• Recurrence of Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• Mirabegron 25mg
Mirabegron 25 mg per day

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Coyne KS, Wein AJ, Tubaro A, Sexton CC, Thompson CL, Kopp ZS, Aiyer LP. The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:4-11. doi: — View Citation

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/Internation — View Citation

Hsiao SM, Chang TC, Chen CH, Wu WY, Lin HH. Frequent nocturia episodes, a suboptimal response to treatment, and small bladder capacity predict the need for persistent antimuscarinic therapy or re-treatment after discontinuation of antimuscarinics in femal — View Citation

Hsiao SM, Liao SC, Chen CH, Chang TC, Lin HH. Psychometric assessment of female overactive bladder syndrome and antimuscarinics-related effects. Maturitas. 2014 Dec;79(4):428-34. doi: 10.1016/j.maturitas.2014.08.009. Epub 2014 Sep 3. — View Citation

Hsiao SM, Lin HH. Medical treatment of female overactive bladder syndrome and treatment-related effects. J Formos Med Assoc. 2018 Oct;117(10):871-878. doi: 10.1016/j.jfma.2018.01.011. Epub 2018 Feb 15. Review. — View Citation

Hsiao SM, Su TC, Chen CH, Chang TC, Lin HH. Autonomic dysfunction and arterial stiffness in female overactive bladder patients and antimuscarinics related effects. Maturitas. 2014 Sep;79(1):65-9. doi: 10.1016/j.maturitas.2014.06.001. Epub 2014 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent OAB	Recurrent OAB with needs to retreatment	January 2015 to July 2019