Status:
COMPLETED
Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Conditions:
Overactive Bladder
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief Summary
To investigate if oxybutynin ER adding on antimuscarinics is more effective than mono-antimuscarinic treatment for patients with refractory OAB
Detailed Description
* Introduction:Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urgency incontinence. Usually no metabolic or anatomical disorders can be found in pati...
Eligibility Criteria
Inclusion
- Patients aged ≥20 years of male or female gender with OAB refractory to one antimuscarinics therapy
- Patient or his/her legally acceptable representative has signed the written informed consent form
Exclusion
- Patients with untreated bladder outlet obstruction, intrinsic sphincter deficiency, pelvic organ prolapse
- Patients with history of urethral injury or transurethral surgery for prostate or bladder
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patients with known active urinary tract infection, urinary stone or malignancy
- Patients have laboratory abnormalities at screening including:
- Aspartate aminotransferase (AST) \> 3 x upper limit of normal range.
- Alanine aminotransferase (ALT) \> 3 x upper limit of normal range.
- Patients have abnormal serum creatinine level \> 2 x upper limit of normal range.
- Patients with urinary retention, PVR≥250 ml
- Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial
- Patients participated investigational drug trial within 1 month before entering this study
- Patients with major psychiatric illness or drug abuse
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01824420
Start Date
March 1 2013
End Date
February 1 2017
Last Update
March 8 2017
Active Locations (1)
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1
Buddhist Tzu Chi General Hospital
Hualien City, Taiwan, 970