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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT03082118
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal women with SUI or stress predominant mixed incontinence
* Maximum score on IQOL of 60
* Positive cough test for leakage
* Willing to undergo procedures
* Free from infection
* Have previously tried (and failed) noninvasive treatment for SUI
Exclusion Criteria:
* SUI due to SUI
* Urge-predominant mixed incontinence
* Incontinence of neurogenic etiology
* 2 or more UTIs in past year and 1 in past 3 months
* Surgery for SUI in the past 6 months
* taking medication that can be used to treat SUI
* taking medication that affects urinary symptoms for less than 3 months
* undergoing biofeedback
* Grade 3 or worse cystocele
* last menstrual period within 12 months
* oral progesterone or estrogen in the past 12 months
* BMI \> 40
* involuntary detrusor contractions or discomfort during bladder filling
* previous stage III or worse cancer
* previous cancer of the urinary tract
* previous symptoms for early stage cancer in the past 2 years
* anticoagulation therapy other than aspirin
* history of prosthetic heart valve
* neurological or connective tissue condition or disease affecting bladder function
* known allergy to device components
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03082118
Study Brief:
Protocol Section:
NCT03082118