Trial · NCT06391372
Effect of Local Estriol Treatment Before Vaginal Repair Surgery
NCT06391372, Phase 3, Active not recruiting, Hatice Tukenmez Kurnaz
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Local Estriol Treatment Before Vaginal Repair Surgery. Trials, record NCT06391372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06391372
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Local Estriol Treatment Before Vaginal Repair Surgery
- NCT number
- NCT06391372
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Hatice Tukenmez Kurnaz
- Conditions
- Pelvic Organ Prolapse, Pelvic Floor Disorders, Menopause, Vaginal Atrophy
- Interventions
- estriol cream
- First posted
- 2024-04-30
- Last updated
- 2025-02-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Secondary | Turkish version of Pelvic Floor Distress Inventory-20 (PFDI-20) was used to evaluate pelvic floor functions in the study and control groups. | The determined questionnaires will be administered to the patients 4 weeks before the surgical procedure, before the surgery and 4 weeks after the surgery. | The PFDI-20 Scale includes 20 items with 3 subscales:POPDI-6,UDI-6, and CRADI-8. The total score of the scale is between 0-300. The best score that can be obtained from the entire survey is 0, the worst score is 300. The higher the score obtained as a result of this survey, the greater the degree of complaint of pelvic floor dysfunction. |
| Secondary | Patient Global Improvement Impression Scale (PGI-I) was used to understand the change in the patient's complaints after vaginal repair surgery in the treatment and control groups. | 4 weeks after surgery | The Patient Global Impression of Improvement Scale (PGI-I) is a tool designed to measure patient interpretation of symptom changes following intervention. We will use it in this study to understand the change in the patient's complaints after vaginal repair surgery in the treatment and control groups. In this way, we will avoid relying on disease-specific questions and the inherent researcher bias that may be present in these questions. PGI-I score was recorded on a 7-point scale where 1 = very much better/improved, 2 = much better/improved, 3 = a little better/improved, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. |
| Secondary | Questioning the feeling of pain/discomfort in the vagina after surgery using VAS | 4 weeks after surgery | Questioning the feeling of pain/discomfort in the vagina after surgery using VAS; We aim to compare the effect of local estriol treatment applied in the preoperative period on these complaints. |
| Secondary | To evaluate the effect of preoperative local estirol treatment on vaginal health in the preoperative period between the study and control groups using the vaginal health index (VHI). | 4 weeks before and before surgery | Vaginal health index (VHI), a quantitative assessment of vaginal health, is used to evaluate vaginal elasticity, fluid volume, vaginal pH level, epithelial integrity, and changes in moisture. The VHI scale is interpreted as ranging from 5 points (severe) to 25 points (normal) on all five parameters. The vaginal health index will be determined in line with the vaginal examination performed by me 4 weeks before and just before the operation. In this way, the effect of preoperative local estirol treatment on vaginal health in the preoperative period will be compared between the study and control groups. |
| Secondary | Turkish version of Pelvic Floor Impact Questionnaire (PFIQ-7) was used to evaluate pelvic floor functions in the study and control groups. | Determined questionnaires will be administered to patients 4 weeks before the surgical procedure, before surgery, and 4 weeks after the surgery. | The Pelvic Floor Impact Questionnaire (PFIQ-7) is a functional status measure that assesses the degree of impact of a person's bowel, bladder, and/or pelvic symptoms on different activities of daily living, social relationships, or emotions. It also has three scales: POPIQ-7; UIO-7; and CRAIQ-7. In the form, patients' complaints were none (0); less (1); middle (2); many (3); It is rated as. Total score ranges from 0 to 21. Lower score means less quality of life impact expresses. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06391372
GET https://conductscience.org/api/trials/v1/NCT06391372/registered