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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01230450
Eligibility Criteria:
Inclusion Criteria:
* USI
* Mixed incontinence symptoms with predominantly bothering stress component (No DO on UDS).
* Primary Incontinence Surgery.
* BMI \< 35
* Ability to understand the information leaflet and sign an informed consent form in English.
* All would have had failed or declined PFMT.
Exclusion Criteria:
* Mixed incontinence with pre-dominant OAB and/or Neurological conditions e.g. MS.
* Detrusor Overactivity on Urodynamics.
* Inability to understand English.
* Un-willing for randomisation.
* Concomitant surgery.
* Patient requiring postoperative hospital-stay for medical or social reasons
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT01230450
Study Brief:
Protocol Section:
NCT01230450