Please select the eligibility criteria that correspond to the clinical trial below.
Title: Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling (OPUS) Trial
Brief Summary: Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incision. Some women develop stress urinary incontinence (SUI) after surgery. A prior randomized trial has shown that use of a Burch sling at the time of an abdominal sacrocolpopexy decreases the risk of urinary incontinence; however, the benefit of adding an anti incontinence procedure to prevent SUI at the time of prolapse surgery performed via a vaginal approach is unclear. Thus, the objective of the Outcomes following vaginal Prolapse repair and mid Urethral Sling (OPUS) trial is to determine whether prophylactic treatment with Tension-free Vaginal Tape (TVT)® at the time of prolapse surgery done via a vaginal approach is effective in preventing urinary incontinence.


Options:
A: 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).
B: Inclusion Criteria:

* Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery

Exclusion Criteria:

* an apical defect indicating concomitant vaginal fixation, or stress urinary incontinence necessitating surgery, or her main symptomatic prolapse component was in the posterior vaginal wall.
C: 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.)
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