Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01824420
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01824420
Study Brief:
Protocol Section:
NCT01824420