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. Author manuscript; available in PMC: 2010 May 29.
Published in final edited form as: Clin Trials. 2009 Apr;6(2):162–171. doi: 10.1177/1740774509102605

Table 1.

Inclusion and Exclusion Criteria*

Inclusion criteria:
  • Vaginal bulge symptoms as indicated by an affirmative response to either question 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 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)

  • 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). Current use of vaginal or systemic (oral, skin patch) estrogen is not an exclusion criterion.

PFDI= Pelvic Floor Distress Inventory, POPQ=Pelvic Organ Prolapse Quantification

*

Urodynamic studies are not required as a part of this trial.