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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT01754558
Eligibility Criteria:
Inclusion Criteria:
\- 1. A medical history of stress urinary incontinence, i.e. leakage during coughing, sneezing or leakage during physical exertion. OR 2. A medical history of mixed urinary stress incontinence defined as complaint of involuntary leakage associated with urgency and stress incontinence. Stress incontinence has to the dominating symptom defined as more episodes of leakage due to coughing or physical exertion than with urgency.
3\. A provocative stress test up to ten coughs at a standardized bladder volume (300 ml) confirming urinary leakage from the urethra while the patient is asked to cough or perform a Valsalva manoeuvre standing or lying (7). Furthermore, the patient has to present hypermobility of the urethra/bladder neck defined as significant downward rotation when coughing or during Valsalva.?
Exclusion Criteria:
1. Previous anti-incontinence surgery.
2. Residual urine volume \>100 ml
3. Bladder capacity \<200ml according to diary.
4. Planned or current pregnancy
5. Repeated urinary tract infections (\>4 cystitis last year )
6. Current anticoagulation therapy that can´t be interrupted in due time prior to surgery
7. Known abnormal coagulation
8. Allergy to local anaesthetics
9. Co-existing pelvic pathology, such as ovarian mass etc
10. Vaginal POPQ anterior prolapse grade \>=2
11. A medical history of predominantly urge urinary incontinence.
12. Patients unable to understand the protocol and a follow up
13. Patients younger than 18 and above or equal to 60 years.
14. Known or suspected neurological condition
15. Patients who have not paused acethylsalicylic acid (ASA) medication 7 days prior to surgery
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01754558
Study Brief:
Protocol Section:
NCT01754558