Effect of Local Estriol Treatment Before Vaginal Repair Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

estriol cream: 1 g intravaginal estriol via applicator twice a week before going to bed for 4 weeks

Study summary

The aim of the study is to evaluate the effects of local estriol treatment applied before vaginal repair surgery on steroid receptors, inflammatory cell response, vascular, connective and nervous tissues in the vagina, and its effects on early postoperative period pelvic floor functions, satisfaction with the surgery and vaginal health.

Eligibility

Primary outcome measure(s)

• Morphological examinations of vaginal tissues obtained after surgery from the study and control groups — 4 weeks after starting local estriol treatment
  1x0.5 cm tissue samples, made by Ankara University Faculty of Medicine, Department of Medical Pathology, will be taken from the vaginal tissues obtained after surgery from the study and control groups. After paraffin blocking, Epithelial thickness will be evaluated during routine histopathological evaluation with H.E staining. Epithelial thickness will be evaluated in micrometers
• Immunohistochemical examinations of vaginal tissues obtained after surgery from the study and control groups — 4 weeks after starting local estriol treatment
  Sections obtained from the blocks will be sectioned with 6 samples per glass, and steroid receptors (ER, PR, AR), CD3/CD20/CD68/CD4/CD8, CD34 and S100 will be stained with the Ventana automatic staining device and as secondary antibodies. (A total of 60 immunohistochemical tests will be performed in 6 glasses of 10 antibodies to be studied). With these dyes, the presence and density of CD3/CD20/CD68/CD4/CD8 and inflammatory cells in the epithelial and subepithelial tissue and the type distribution of immune cells will be determined. Vascular endothelial density will be evaluated with CD34 and nerve fiber density will be evaluated with S100.
• Morphological examinations of vaginal tissues obtained after surgery from the study and control groups — 4 weeks after starting local estriol treatment
  The alignment and maturation of vaginal epithelial squamous cells will be evaluated during routine histopathological evaluation. Alignment and maturation of squamous cells will be evaluated as a percentage.
• Morphological examinations of vaginal tissues obtained after surgery from the study and control groups — 4 weeks after starting local estriol treatment
  Connective tissue changes in the vaginal subepithelial area will be evaluated during routine histopathological evaluation. Connective tissue change in the subepithelial area will be evaluated as a percentage.
• Morphological examinations of vaginal tissues obtained after surgery from the study and control groups — 4 weeks after starting local estriol treatment
  Distribution of vaginal vascular structures will be evaluated during routine histopathological evaluation. Distribution of vascular structures will be evaluated as a percentage.

Trial sites (1)

Other trials for the same condition