Effect of Local Estriol Treatment Before Vaginal Repair Surgery

What this trial studies

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.

Conditions in scope

• Pelvic Organ Prolapse
• Pelvic Floor Disorders
• Menopause
• Vaginal Atrophy

Interventions

• estriol cream (Drug) — 1 g intravaginal estriol via applicator twice a week before going to bed for 4 weeks

Who can join

Women only · Adults (Child, Adult, Older Adult)

Inclusion criteria

• Postmenopausal women with a diagnosis of pelvic organ prolapse and an indication for vaginal repair surgery including colporrhaphy anterior and/or posterior surgery

Exclusion criteria

• Psychiatric and neurological disease that causes disability in mental and motor functions
• receiving systemic/local hormone replacement therapy in the last three months
• applying vulvar/local steroids for any reason within the last three months
• receiving treatment for pelvic and/or lower genital tract infection in the last three months
• history of malignancy
• previous vaginal repair surgery with/without mesh

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE3
• Start date: 2024-04-01
• Primary completion: 2025-03
• Last update posted: 2025-02-05
• First posted: 2024-04-30

Sponsor & contact

Lead sponsor: Hatice Tukenmez Kurnaz (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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…
• 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.

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