Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Comparison Among Three Single-incision Devices for the Treatment of Female Urinary Genuine Stress Incontinence: a Randomized Controlled Study.
Brief Summary: The prevalence of urinary stress incontinence in middle age women is rated at about 30%. To date, there is an increasing use in the clinical practice of new techniques for the treatment of this condition and several surgical devices, characterized by minimally invasive approach, are commercialized.

Recently, single-incision devices have been proposed. One of the most relevant potential advantages of these devices is the possibility of performing their positioning under local anesthesia, thus, in ambulatory regimen. The employment of these devices is particularly useful in two subgroups of patients with urinary incontinence, i.e. women with genuine stress incontinence not associated to pelvic organ prolapse (POP) and women whose stress incontinence raised after surgical correction of (severe) POP.

Poor data coming from randomized controlled trials (RCTs) are available regarding single-incision devices for the treatment of stress incontinence, and there are no conclusions in terms of their feasibility, efficacy and safety. Finally, to our knowledge no randomized controlled trial is actually available in literature comparing different single-incision devices.


Options:
A: Inclusion Criteria:

* genuine stress incontinence

Exclusion Criteria:

* pregnancy
* \<12 months postpartum
* systemic disease and/or drugs known to affect bladder function
* current chemotherapy or radiation therapy
* urethral diverticulum
* augmentation cytoplasty
* artificial sphincter
* genital prolapse equal to or more than second degree
* history of severe abdominopelvic infections
* detrusor instability and/or intrinsic sphincter dysfunction
* other gynecologic pathologies
* BMI \>30
B: Inclusion Criteria:

* Urinary incontinence symptoms
* Urodynamic stress incontinence confirmed with multichannel urodynamic testing
* Age of at least 21 years
* Desires surgical correction of stress urinary incontinence

Exclusion Criteria:

* Post-void residual volume \>100cc
* Detrusor overactivity on preoperative multichannel urodynamic testing
* History of previous synthetic, biologic or fascial sub-urethral sling
* Desires future childbearing
* History of bleeding diathesis or current anti-coagulation therapy
* Current genitourinary fistula or urethral diverticulum
* Reversible cause of incontinence (i.e. drug effect)
* Contraindication to surgery
C: 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
D: Inclusion Criteria:

* Clinical and urodynamic for stress urinary

Exclusion Criteria:

* Detrusor overactivity (urodynamic study)
* Urodynamic changes suggesting reduced vesical capacity
* Associated neurological diseases
* Coagulopathies
* Pregnancy
* Foreign matter sensitiveness history
* Acute urinary tract infection
* Sequel from high ionizing radiation exposure
* Use of drugs that may result in high surgical risk and/or significant postoperative complication
* Anesthetic procedure contraindication
* Vulvovaginitis: presence of vaginal secretion with infection clinically or lab supported

Answer: A