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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT00803959
Eligibility Criteria:
Inclusion Criteria:
1. Female
2. Predominant SUI as evidenced by all of the following:
1. Self-reported stress-type UI symptoms, of duration \>3 months\*
2. MESA stress symptom score (percent of total possible stress score) greater than MESA urge symptom score (percent of total possible urge score)
3. Observation of leakage by provocative stress test at any volume
4. Eligible for randomization to either treatment group
5. Eligible for SUI surgery
6. Desires non-conservative therapy for SUI
7. PVR \<150ml by any method. (May repeat once if initial measure is abnormal)
8. Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture
9. Available to initiate SUI treatment within 6 weeks of randomization
10. Available for 12-months of follow-up and able to complete study assessments, per clinician judgment.
11. Signed consent form.
* Patient can be rescreened after respective time interval has been met.
Exclusion Criteria:
1. Age \<21 years\*
2. Currently undergoing or has had recommended treatment of apical or anterior prolapse
3. No anterior or apical prolapse \> +1 on standing straining prolapse exam
4. Pregnant or has not completed child bearing.
5. \<12 months post-partum\*†
6. Active malignancy of cervix, uterus, fallopian tube(s) or ovary \> Stage I, or bladder of any Stage
7. History of pelvic radiation therapy
8. Previous incontinence surgery
9. Current catheter use
10. Neurological disease known to affect bladder storage (e.g. MS, Parkinsonism, CVA)
11. Previous (i.e. repaired) or current urethral diverticulum
12. Prior augmentation cystoplasty or artificial sphincter
13. Implanted nerve stimulators for urinary symptoms or previous botox bladder injections.
14. Any pelvic surgery within the last 3 months\*
15. Previous placement of synthetic mesh on a vaginal approach in the anterior compartment
16. Participation in another treatment intervention trial that might influence results of this trial.
17. A urodynamic result reviewed by the investigator in the preceding 12 months or any recollection by the investigator of urodynamic results on that subject.
* Patient can be rescreened after respective time interval has been met.
* "Partum" is defined as a delivery or other termination that occurs after 20 weeks gestation.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT00803959
Study Brief:
Protocol Section:
NCT00803959