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:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT00847535
Eligibility Criteria:
Inclusion Criteria:
* Patient has SUI with normal detrusor activity confirmed with urodynamics
* Patient has bladder capacity \>200 mL
* Patient's incontinence has not shown any improvement for at least -6 months
* Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
Exclusion Criteria:
* Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
* Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
* Patient has uncontrolled diabetes
* Patient is pregnant, lactating, or plans to become pregnant during the course of the study
* Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
* Patient has current or acute conditions involving cystitis or urethritis
* Patient is scheduled to receive radiation treatment to the vicinity
* Patients with a history of radiation treatment to the urethra or adjacent structures
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00847535
Study Brief:
Protocol Section:
NCT00847535