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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT03987594
Eligibility Criteria:
Inclusion Criteria:
* 1\. cystoscopically proven Hunner lesion, without other demonstrable lower urinary tract diseases
* 2\. Adult patient aged more than 19 years
* 3\. Duration of IC/BPS symptom of more than 6 months
* 4\. VAS pain score more than point 4 (including point 4)
* 5\. The total score of O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) symptom and problem is more than 12 with the score of pain item is more than 2
* 6\. The total score of Pelvic pain urgency/frequency patient symptom scale more than point 13
Exclusion Criteria:
* 1\. Patient with history of bladder hydrodistension or transurethral fulguration within the period of 3 months
* 2\. Women patients who are likely to become pregnant
* 3\. Patients with average voided volume more than 400ml
* 4\. Patients with hematuria suspicious of malignancy
* 5\. Patients with microbiologically proven urinary tract infection during the screening period
* 6\. Patients with microbiologically proven recurrent urinary tract infection, more than twice during the last 6 months or more than three times of infection during the last year
* 7\. Patients with previous history of genitourinary tuberculosis
* 8\. Patients with previous history of genitourinary malignancy
* 9\. Patients with previous history of bladder augmentation
* 10\. Patient with following surgery within recent 6 months at screening; hysterectomy, midureteral or suburethral sling operation, transvaginal operation, pelvic organ prolapse surgery, vaginal delivery, Caesarean section, prostate surgery, and any other treatment that might affect bladder sensation and bladder function.
* 11\. Patients with neurological diseases which might affect bladder function
* 12\. patients who rely on assisted emptying ; like clean intermittent catheterization or indwelling catheterization
* 13\. patients who are planning to rehabilitation treatment affect the bladder function, like intravesical electronic stimulation
* 14\. patient with alcohol or drug addiction
* 15\. any patient who are not fit for the study based on the investigator's decision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
29 Years
Maximum Age:
83 Years
Study:
NCT03987594
Study Brief:
Protocol Section:
NCT03987594