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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT03671694
Eligibility Criteria:
Inclusion Criteria:
1. Female patient, aged 18 years or older at the time of enrollment,
2. primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation; for a duration of at least 3 months (patient can be rescreened after this time interval has passed).
3. The patient agrees to no new parallel treatment for SUI during the treatment period and the 6 months following it.
4. objective proof of SUI: Observation of urine leakage by cough and valsalva (positive stress test) at a bladder volume of ≤ 300cc
5. Bladder capacity ≥200cc
6. Post void residual ≤100cc with Stage I or lower pelvic organ prolapse
Exclusion Criteria:
1. Patient is pregnant, lactating, or plans to become pregnant during the course of the Study; or Patient is \<12 months post partum
2. Patient has other predominant type of UI (eg Urgency UI, overflow UI, fistula)
3. Patient has a vaginal condition that does not allow proper vaginal placement of the laser probe in its protective speculum
4. Current chemo/ radiotherapy; history of pelvic radiation
5. Systemic diseases known to affect bladder function (eg Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury)
6. Current or history of urethral diverticulum, prior augmentation cystoplasty, implanted nerve stimulators for bladder symptoms
7. History of synthetic sling
8. Pelvic surgery \< 3 months
9. Current evaluation or treatment for chronic pelvic pain
10. Patient has pelvic organ/ vaginal prolapse extending to or out of the vaginal opening
11. Participation in another treatment intervention that might interfere with the results of this trial
12. Patient has a medical condition or disorder that may limit life expectancy or that may cause non-compliance with the protocol (e.g. unable to perform self-evaluations and/or accurately report medical history, urinary symptoms, and/or data).
13. Patient has ambulatory 24 hour pad test, where the increased pad weight is \< 3 grams.
14. Patient is non-ambulatory (ambulatory with assistive devices allowed)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03671694
Study Brief:
Protocol Section:
NCT03671694