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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT04253067
Eligibility Criteria:
Inclusion Criteria:
1. Female
2. Age ≥18 years and ≤75 of age
3. Mild to moderate SUI defined by Stamey Grade 1 and 2
4. Positive bladder stress test at screening
5. Negative urinary tract infection (UTI) at the time of study enrollment. If a patient does have a UTI, they may be rescreened after treatment
6. No additional SUI therapy in the past 2 months such as pelvic floor physical therapy, medications, or participation in another SUI study
7. No prior history of midurethral sling or fascial sling for SUI
8. No prior history of urethral bulking procedure for SUI
9. No prior history of autologous muscle derived stem cell injection in the urethra
10. Must sign the informed consent form
11. Must be willing to comply with the study protocol
Exclusion Criteria:
1. Contraindications to fCO2 laser treatment, such as:
1. previous pelvic mesh surgery
2. current or previous genital cancers,
3. radiation to the vaginal or colo-rectal tissue,
4. currently pregnant or less than 3 months following pregnancy
5. active infections (candidiasis, herpes genitalis, etc.)
6. vaginal or cervical lesions noted on initial exam
2. Patients with undiagnosed vaginal bleeding not related to menses
3. Active vulvar or vaginal infection, including herpes
4. Current UTI, confirmed by positive urine culture and patient-reported UTI symptoms
5. Recurrent UTI defined as 3 UTIs in the past 6 months or 4 UTIs in the past 1 year
6. Pelvic or vaginal surgery within the past 9 months
7. Pelvic organ prolapse beyond the introitus
8. Patient possesses any other characteristics that, per the investigator's judgment, deems them unsuitable (i.e. may increase patient's risk, may affect the conduct of the study, etc.) for the treatment and/or study.
9. Participation in an investigational trial that used a study treatment, medication and/or biologic within 30 days or less prior to the date of the screening visit.
Deferral
Patients may be deferred and rescreened at a later date under the following conditions:
* Patients with active vulvar or vaginal infections may be rescreened after treatment
* Patients with an active UTI may be rescreened after treatment
* Patients with undiagnosed vaginal bleeding may be rescreened after complete work-up, treatment and resolution of vaginal bleeding
* Patients pregnant within the past 3 months
* Patients with recent vaginal or uterine surgery within the 9 months
Note: To preserve the scientific integrity of the study some inclusion and exclusion criteria are not listed. At the conclusion of the study all items will be posted.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04253067
Study Brief:
Protocol Section:
NCT04253067