Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of Trimo-San Gel for the Prevention of Pessary-associated Bacterial Vaginosis
Brief Summary: The primary objective of this prospective, randomized, controlled study is to assess the effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for \>1 year are recruited in to the study and randomized to using Trimo-San gel daily or not using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain, but will have a positive effect on the subjective symptoms experienced by women wearing pessaries.


Options:
A: Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains. (baseline and 2-12 weeks after treatment (at time of surgery))
B: Vaginal Wall Composition: Epithelium (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Epithelium (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Muscularis (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Muscularis (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); hCOL1A1, Per-Protocol (Time of surgery, i.e. after 6-8 weeks of intervention); Total Collagen Content in Vaginal Muscularis, (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Degradative Activity, Muscularis, MMP-9 (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Lamina Propria (Intention to Treat) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Composition: Lamina Propria (Per-Protocol) (Time of surgery, i.e. 6-8 weeks of intervention); hCOL3, (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Lysyl Oxidase (LOX) (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); LOXL1 (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Tropoelastin (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); TGFB1 (Per-Protocol) (Time of surgery, i.e. after 6-8 weeks of intervention); Vaginal Wall Degradative Activity, Mucosa, MMP-9 (Time of surgery, i.e. after 6-8 weeks of intervention)
C: "Much Better" or "Very Much Better" on PGI-I at 3 Months (Outcome was measured at three months following randomization.); No Bothersome Stress Incontinence Symptoms at 3 Months (Outcome was measured at three months following randomization.)
D: Number of Patients With Bacterial Vaginosis at 3 Months (3 months)

Answer: D