A Phase 3 interventional study of estriol cream in Pelvic Organ Prolapse, Pelvic Floor Disorders and Menopause, sponsored by Hatice Tukenmez Kurnaz. Active, not recruiting at 1 site in Turkey. Open to female participants. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Hatice Tukenmez Kurnaz · Phase 3, Interventional, and Treatment
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.
Pelvic organ prolapse (POP) is the herniation of pelvic organs into or beyond the vaginal walls and is a common health problem that affects daily activities and sexual function. Its negative impact on women's quality of life has been the subject of clinical research all over the world due to the economic burden it brings to the healthcare system.
The use of different classification systems for diagnosis and the fact that many women with mild prolapse are asymptomatic make it difficult to determine the exact prevalence of pelvic organ prolapse. Among women aged 50-79, the prevalence is 41% and the lifetime risk of prolapse surgery is 11%. This risk is expected to increase in the future.
Advancing age and postmenopausal status are known risk factors for pelvic organ prolapse. Since estradiol receptors alpha and beta (ESR1/2) are found in the squamous epithelium of the bladder, urethra, vagina, and pelvic floor muscles, it is evident that the pelvic organs and their surrounding muscle and connective tissue are sensitive to estrogen and that menopause is an important risk factor for the development of pelvic organ prolapse. The decline in estrogen during the postmenopausal period contributes not only to symptoms of pelvic organ prolapse but also to other pelvic floor disorders, including vulvovaginal atrophy, stress urinary incontinence (SUI), urge urinary incontinence (UUI), sexual dysfunction, and dyspareunia.
Studies show that estrogen levels have a significant impact on the function of the genital and lower urinary tract. Estrogen regulates the function of the vascular smooth muscles in the vaginal wall, affecting vaginal wall perfusion and smooth muscle tone. It also regulates bladder smooth muscle contractility, cellular and extracellular composition, and nerve density.
Local estrogen therapy (LET) works by increasing vaginal tissue blood flow, epithelial thickening, increased epithelial secretion and decrease in vaginal pH. From a physiological and psychosocial perspective, women using estrogen therapy describe positive effects such as normalization of sexual function, increased quality of life, improvement in relationships with their spouses, feeling 'less old', higher self-esteem and having a better social life.
In recent years, local estrogen therapy has become the focus of treatment of pelvic floor disorders. Various conservative and surgical methods have been described in the treatment of pelvic organ prolapse. Conservative treatment methods include topical estrogen. Among the surgical approaches, many vaginal and abdominal methods with or without graft material have been described. Surgical methods are mostly preferred in treatment.
The primary goal of POP surgery is to reduce symptoms and improve health-related quality of life. However, despite the continuous evolution in current surgical techniques, recurrence of symptoms is common. It is important to find ways to improve pelvic organ prolapse surgery outcomes. It is unclear whether preoperative LET is beneficial. Ismail and colleagues concluded in a Cochrane systematic review that further studies with long-term follow-up are needed to evaluate the effects of estrogen preparations before prolapse surgery.
The aim of this study is to evaluate the effects of preoperative local estriol application on the vaginal tissues and the effects of preoperative local estriol application on early postoperative period pelvic floor functions, satisfaction with the surgery and vaginal health in postmenopausal women planned for vaginal repair surgery.
As a result, steroid receptors (ER, PR, AR), immune cell types and distribution, CD34 and vascular endothelial density, collagen fiber density, S100 in the anterior and/or posterior vaginal wall in patients with and without local estriol treatment before colporrhaphy anterior and/or posterior. The difference in nerve fiber density and epithelial maturation index levels will be investigated. In addition, the Pelvic Floor Distress Inventory (PFDI-20), which is valid in Turkish, Pelvic Floor Impact Questionnaire (PFIQ-7), Patient General Impression of Improvement (PGI-I) and VAS scoring and early postoperative pelvic floor functions were evaluated in the study and control groups before and after surgery. and patient satisfaction regarding the surgery will be compared. There will also be comparisons between the pre-surgical study and control group through the vaginal health index (VHI), which is a quantitative assessment of vaginal health. Follow-ups are planned to be carried out with the patients' routine check-up visits to the hospital.
197 studies on the registry are indexed under Pelvic Floor Disorders; 45 are open to participants now.
This study's planned enrollment of 36 is below the median of 64 across 136 interventional studies indexed under Pelvic Floor Disorders.
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-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:
Patients will receive 1 g of intravaginal estriol via an applicator twice a week before going to bed for 4 weeks preoperatively.
Drug: estriol cream
Patients who met the same criteria as the study group and were not treated with local estriol
1 g intravaginal estriol via applicator twice a week before going to bed for 4 weeks
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups
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
Time frame: 4 weeks after starting local estriol treatment
Immunohistochemical examinations of vaginal tissues obtained after surgery from the study and control groups
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.
Time frame: 4 weeks after starting local estriol treatment
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups
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.
Time frame: 4 weeks after starting local estriol treatment
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups
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.
Time frame: 4 weeks after starting local estriol treatment
Morphological examinations of vaginal tissues obtained after surgery from the study and control groups
Distribution of vaginal vascular structures will be evaluated during routine histopathological evaluation. Distribution of vascular structures will be evaluated as a percentage.
Time frame: 4 weeks after starting local estriol treatment
Turkish version of Pelvic Floor Distress Inventory-20 (PFDI-20) was used to evaluate pelvic floor functions in the study and control groups.
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.
Time frame: The determined questionnaires will be administered to the patients 4 weeks before the surgical procedure, before the surgery and 4 weeks after the surgery.
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.
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.
Time frame: 4 weeks after surgery
Questioning the feeling of pain/discomfort in the vagina after surgery using VAS
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.
Time frame: 4 weeks after surgery
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).
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.
Time frame: 4 weeks before and before surgery
Turkish version of Pelvic Floor Impact Questionnaire (PFIQ-7) was used to evaluate pelvic floor functions in the study and control groups.
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.
Time frame: Determined questionnaires will be administered to patients 4 weeks before the surgical procedure, before surgery, and 4 weeks after the surgery.
VAS scoring for postmenopausal genitourinary syndrome complaints in the study and control groups
Through VAS evaluation, the severity of genital burning, genital dryness, genital itching and dysuria symptoms of the patients in the study and control groups will be scored between 0-10. Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into numerical values.No complaints are scored as 0 points and complaints of the worst severity imaginable are rated as 10 points.
Time frame: Determined questionnaires will be administered to patients 4 weeks before the surgical procedure, before surgery, and 4 weeks after the surgery.
Plan to share: No
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