Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391372
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-05
Brief Title:
Effect of Local Estriol Treatment Before Vaginal Repair Surgery
Sponsor:
Hatice Tukenmez Kurnaz
Organization:
Ankara University
Study Overview
Official Title:
Effect of Local Estriol Treatment Before Vaginal Repair Surgery on Vaginal Tissues and Early Postoperative Pelvic Floor Functions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 womens 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 ESR12 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 andor posterior vaginal wall in patients with and without local estriol treatment before colporrhaphy anterior andor 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
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 ESR12 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 andor posterior vaginal wall in patients with and without local estriol treatment before colporrhaphy anterior andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None