Flexibly adding-on Second Antimuscarinic Agent to the First Antimuscarinics for Refractory Overactive Bladder Syndrome

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate if oxybutynin ER adding on antimuscarinics is more effective than mono-antimuscarinic treatment for patients with refractory OAB

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Treatments: Mandelic Acids; Muscarinic Antagonists; Oxybutynin; Tolterodine Tartrate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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:

1. Aspartate aminotransferase (AST) > 3 x upper limit of normal range.

2. Alanine aminotransferase (ALT) > 3 x upper limit of normal range.

3. 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