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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01054833
Eligibility Criteria:
Inclusion Criteria:
A patient must satisfy the following criteria before entering the study:
1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with ISD. Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
2. Patient is age 18 or older.
3. Patient had a hysterectomy, tubal ligation or is otherwise incapable of pregnancy, or had a negative pregnancy test prior to study entry and has decided to cease childbearing.
4. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent.
Exclusion Criteria:
* A patient who meets any of the following criteria will be excluded from participating in the study:
1. Patient has an associated or suspected neurological disease.
2. Patient is on anti-coagulation therapy.
3. Patient has received an investigational drug or device in the past 60 days.
4. Patient has an active lesion or present injury to perineum or urethra.
5. Patient has a urethral obstruction.
6. Patient has a significant cystocele \> ICS Stage 2.
7. The subject has active infection upon urine dipstick analysis, defined as ≥ +1 leukocytes or ≥ +1 nitrates (Must reschedule appointment after UTI resolves.)
8. Patients with combined POP surgery.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01054833
Study Brief:
Protocol Section:
NCT01054833