Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793476
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-03-20
Brief Title:
Therapeutic Efficacy of ErbiumYAG Laser in Postpartum Patients With Episiotomy Scars
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
Therapeutic Efficacy of ErbiumYAG Laser in Postpartum Patients With Episiotomy Scars in Respect of Genital Pelvic Pain and Scar Tissue Healing A Randomized Sham-Controlled Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Episiotomy is a planned surgical incision to the perineum and posterior wall of the vagina during the second stage of labor The fibrotic and sclerotic scar tissue formed as part of the healing process of episiotomies may cause pain Therefore episiotomy is associated with sexual dysfunction due to the painful sexual intercourse chronic pain and infections and scarring in long term ErYAG laser is a safe option for the treatment of vulvar pain
ErYAG laser is a non-invasive and non-ablative procedure that strengthens the connective tissue in the vaginal wall It provides controlled thermal energy and causes shrinkage of collagen fibrils of the vaginal epithelium and lamina propria It also induces neocollagenesis elastogenesis and neoangiogenesis by temperature change ErYAG laser is also an effective modality to treat the scar tissue formed after the mediolateral episiotomy since it is a matter of functionality and esthetics By tissue remodeling effect ErYAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain
In this study the therapeutic effect of ErYAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain
ErYAG laser is a non-invasive and non-ablative procedure that strengthens the connective tissue in the vaginal wall It provides controlled thermal energy and causes shrinkage of collagen fibrils of the vaginal epithelium and lamina propria It also induces neocollagenesis elastogenesis and neoangiogenesis by temperature change ErYAG laser is also an effective modality to treat the scar tissue formed after the mediolateral episiotomy since it is a matter of functionality and esthetics By tissue remodeling effect ErYAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain
In this study the therapeutic effect of ErYAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain
Detailed Description:
Episiotomy is a planned surgical incision to the perineum and posterior wall of the vagina during the second stage of labor The fibrotic and sclerotic scar tissue formed as part of the healing process of episiotomies may cause pain Therefore episiotomy is associated with sexual dysfunction due to the painful sexual intercourse chronic pain and infections and scarring in long term 40 of the patients complain about persisted dyspareunia after 6 months of delivery Genital pelvic painpenetration disorders disturb the quality of sexual life of the couple and affect the psychology and wellbeing of the partners Since vulva is rich in afferent nerve endings episiotomy scar healing is associated with pain ErYAG laser is a safe option for the treatment of vulvar pain
ErYAG laser is a non-invasive and non-ablative procedure that strengthens the connective tissue in the vaginal wall It provides controlled thermal energy and causes shrinkage of the collagen fibrils in the vaginal epithelium and lamina propria It also induces neocollagenesis elastogenesis and neoangiogenesis by temperature change With minimum damage to the peripheral tissue the viable cells in the target tissue react to this temperature change by expressing heat shock proteins HSP Then HSP increases the levels of transforming growth factor-beta fibroblast growth factor epidermal growth factor platelet-derived growth factor vascular epithelial growth factor which induce neocollagenesis and neoangiogenesis Therefore the thermal energy stored in the vaginal wall induces proliferation of the epithelium which is rich in glycogen neovascularization and collagen production in the lamina propria ErYAG laser is also an effective modality to treat the scar tissue formed after the mediolateral episiotomy since it is a matter of functionality and esthetics By tissue remodeling effect ErYAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain
In this study the therapeutic effect of ErYAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain
ErYAG laser is a non-invasive and non-ablative procedure that strengthens the connective tissue in the vaginal wall It provides controlled thermal energy and causes shrinkage of the collagen fibrils in the vaginal epithelium and lamina propria It also induces neocollagenesis elastogenesis and neoangiogenesis by temperature change With minimum damage to the peripheral tissue the viable cells in the target tissue react to this temperature change by expressing heat shock proteins HSP Then HSP increases the levels of transforming growth factor-beta fibroblast growth factor epidermal growth factor platelet-derived growth factor vascular epithelial growth factor which induce neocollagenesis and neoangiogenesis Therefore the thermal energy stored in the vaginal wall induces proliferation of the epithelium which is rich in glycogen neovascularization and collagen production in the lamina propria ErYAG laser is also an effective modality to treat the scar tissue formed after the mediolateral episiotomy since it is a matter of functionality and esthetics By tissue remodeling effect ErYAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain
In this study the therapeutic effect of ErYAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain
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?:
None
Is an FDA AA801 Violation?:
None