Clinical trial

Effect of Local Estriol Treatment Before Vaginal Repair Surgery on Vaginal Tissues and Early Postoperative Pelvic Floor Functions

ID

Name

2023000504-2

Description

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.

Trial arms

Trial start

2024-04-01

Estimated PCD

2025-01-01

Trial end

2025-01-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

estriol cream

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

Arms:

local estriol

Size

36

Primary endpoint

Morphological examinations of vaginal tissues obtained after surgery from the study and control groups

4 weeks after starting local estriol treatment

Immunohistochemical examinations of vaginal tissues obtained after surgery from the study and control groups

4 weeks after starting local estriol treatment

Morphological examinations of vaginal tissues obtained after surgery from the study and control groups

4 weeks after starting local estriol treatment

Morphological examinations of vaginal tissues obtained after surgery from the study and control groups

4 weeks after starting local estriol treatment

Morphological examinations of vaginal tissues obtained after surgery from the study and control groups

4 weeks after starting local estriol treatment

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients who will be administered 1 g of intravaginal estriol via an applicator twice a week before going to bed for 4 preoperative weeks will constitute the study group. Patients who meet the same criteria as the study group and are not treated with local estriol will constitute the control group.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'pathologist who will examine the tissue samples in the study', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

Updated at

2024-04-30

1 organization

1 product

4 indications

Organization

Hatice Tukenmez Kurnaz

Product

Indication

Pelvic organ prolapse

Indication

Pelvic Floor Disorders

Indication

Indication

Atrophic vaginitis