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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT00984958
Eligibility Criteria:
Inclusion Criteria:
Ability to understand the information and to give informed consent.
* At least 50 years of age
* History of urinary leakage during low grade physical activity. A woman with genuine stress incontinence has urinary incontinence during running or jumping. Women with suspected ISD have incontinence at much lower grade of physical activity such as slow walking or standing up and just coughing. Walking, standing up from a chair, and coughing are regarded as low grade of physical activity.
* A positive pad-test (after coughing 10 times) with increase of minimum of 10 grams of urine with 300 ml in the bladder or a 24 h pad-test of more than 100 mg of urine
* No hypermobility of the urethra during cough test.
* Low pressure of the urethra (optional?)
* With a of average miction volume of minimum 150 ml and at least one volume of more than 250
Exclusion Criteria:
* Women with hypermobility of the urethra during coughing and positive Bonney's test
* Women suitable for a TVT procedure.
* Positive urinary culture
* Urge incontinence
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Study:
NCT00984958
Study Brief:
Protocol Section:
NCT00984958