Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study
Brief Summary: Summary:

Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure.

Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse.

Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%.

The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. We therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure.

The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits.

Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive our standard treatment.

The study is performed in all the Scandinavian countries.


Options:
A: Inclusion Criteria:

* Women aged \> 55 yr
* Women with anterior vaginal wall prolapse stage \>2 according to POP-Q classification
* Good understanding the language in word and writing

Exclusion Criteria:

* A history of previous major pelvic surgery with the exception of a hysterectomy for reasons other than genital prolapse
* Patients with previous vaginal surgery because of defects in the anterior of posterior compartments
* Previous hysterectomy because of vaginal prolapse
* Patients with prolapse of uterus or an enterocele \> stage 2
* Patients with previous TVT performed through the obturator membrane
* History of genital or abdominal cancer
* Patients treated with corticosteroids
* Not able to understand the study protocol (language problems, cognitive dysfunction etc.)
B: Inclusion Criteria:

* All patiAll patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.

Exclusion Criteria:

* Unable to give informed consent to participate
C: Inclusion Criteria:

Vaginal bulge symptoms as indicated by an affirmative response to either questions 4 or 5 of the PFDI:

* Do you usually have a sensation of bulging or protrusion from the vaginal area?
* Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? Anterior vaginal prolapse defined by pelvic organ prolapse quantification (POP-Q) Point Aa ≥ -1 cm (i.e., -1,0,1,2, or 3 cm).

Surgical plan that includes a vaginal approach for apical or anterior prolapse repair.

Able and willing to complete data collection per protocol, including written informed consent.

Exclusion Criteria:

Pregnancy or planning pregnancy in the first postoperative year. Any prior mid urethral sling. Currently participating in another interventional study for urinary incontinence.

Untreated urinary tract infection (may be included after resolution).

Overt symptoms of stress urinary incontinence as defined by a positive response to any of the following 3 PFDI items:

* Do you usually experience urine leakage related to coughing, sneezing, or laughing?
* Do you usually experience urine leakage related to physical exercise such as walking, running, aerobics, or tennis?
* Do you usually experience urine leakage related to lifting or bending over? Currently being treated for stress urinary incontinence with pessary/incontinence ring, pelvic floor muscle exercise or medication (duloxetine and imipramine, and alpha agonists).
D: Inclusion Criteria

1. Eligibility for primary procedure (sacrocolpopexy)
2. Eligibility for secondary procedure (Burch colposuspension)
3. Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
4. Negative stress incontinence screen
5. Negative stress incontinence screen (MESA questionnaire)

Exclusion Criteria

1. Contraindication for sacrocolpopexy or Burch colposuspension.

   * Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm).
   * Surgeon judgment that a contraindication to Burch colposuspension exists.
2. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
3. Inability to provide informed consent or to complete testing or data collection.
4. Currently pregnant.

Answer: A