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:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
NCT ID:
NCT01924728
Eligibility Criteria:
Inclusion Criteria:
* Female aged at least 21 years old
* Demonstration of stress urinary incontinence by vaginal examination with half full bladder (200 to 250ml)
* ICIQ UI SF score ≥ 6 points
* Able and agree to carry out one hour pad test
Exclusion Criteria:
* Acute severe infections
* Urinary tract infections and hematuria, active vaginal lesions or infections
* Pelvic organ prolapse stage III and IV, severe urethral sphincter weakness/defect, suspected fistula
* Severe cardiac arrhythmia
* Cardiac pacemaker or other implanted metallic devices
* History of pelvic irradiation
* Pregnant, or actively trying to conceive.
* Neurologic conditions such as epilepsy, Parkinson disease, multiple sclerosis
* Patient who has been treated with electromagnetic stimulation
* Concurrent medications with alpha-adrenergic antagonists (e.g. terazosin, tamsulosin, doxazosin), diuretics, serotonin/norepinephrine reuptake inhibitors (SNRIs) or any other medications known to worsen incontinence.
* Post void residual volume of ≥ 200ml
* Random blood sugar \>10 mmol/L
* Patient who had pelvic or gynaecological surgery for less than three weeks
* Patient scheduled for pelvic or gynaecological surgery in the next eight weeks
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT01924728
Study Brief:
Protocol Section:
NCT01924728