Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicentric Comparative Randomized Study of the Single-incision Sling Ajust® Versus Suburethral Transobturator Slings.
Brief Summary: The transobturator tension-free vaginal tape (TOT) procedure has demonstrated high cure rates comparable to those obtained by retropubic suburethral tape, becoming the first line treatment for stress urinary incontinence (SUI) in many cases. The TOT procedure is not exempt from complications such as bleeding, bladder injuries and pain in the thigh/groin. In addition it is commonly performed under general or regional anesthesia1-3. The single-incision mini-slings (SIMS) were developed to reduce the risk of complications by avoiding the blind passage of the trocars through the obturator space. In addition, the use of SIMS could enable surgeons to perform the procedure truly under local anesthesia.

Different devices for SIMS procedure are available. However, the evidence about their efficacy is controversial4-7. The main limitation of these devices could be the predetermined length of the mesh and the weakness on its fixation. The design of the SIMS Ajust® allows adjusting the length of the sling to each individual woman and provides a robust fixation into the obturator membrane. Recent prospective studies on the efficacy and safety of the sling Ajust® have obtained promising results8,9. Even so, the NICE guidelines advise to use SIMS in the context of research studies10.

The objective of this study is to establish if the effectiveness of the SIMS Ajust® is non-inferior to that of a standard TOT, as well as to compare the comorbidity of both procedures. Owing to the new appearance and fast evolution of these procedures, randomized comparative studies with SIMS are required in order to determine its place in the treatment of SUI.


Options:
A: Inclusion Criteria:

1. Patients must be female
2. Subjective evidence of stress predominant symptoms on symptom specific questionnaire
3. Stress incontinence on urodynamics
4. Patients who are capable of understanding and signing the written consent form for participation in the study
5. Patients must have completed their family
6. Patients must be capable of filling in the symptom diary and micturition diary

Exclusion Criteria:

1. Patients who are medically unfit to undergo surgical intervention.
2. Patients who have undergone previous continence surgery
3. Prolapse beyond the introitus
4. Patients with voiding dysfunction
5. Patients with recurrent urinary tract infections
6. Patients with haematuria of unknown origin or known bladder pathology
7. Patients who are not sure that their family is complete
8. Patients unwilling to use a safe method of contraception following the procedure
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:

* Stress urinary incontinence with urethral hypermobility.

Exclusion Criteria:

* Incapacity to understand the information or give their consent.
* Previous anti-incontinence surgery with slings.
* Urethral hypomobility (Q-tip test \<30º).
* Low pressure urethra (MUCP \< 20cmH2O).
* Detrusor overactivity.
D: 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

Answer: C