Therapeutic Efficacy of Erbium:YAG Laser in Postpartum Patients With Episiotomy Scars

Vulvodynia Clinical Trial

Official title:

Therapeutic Efficacy of Erbium:YAG Laser in Postpartum Patients With Episiotomy Scars in Respect of Genital Pelvic Pain and Scar Tissue Healing: A Randomized Sham-Controlled Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793476
• Other study ID #: E-83045809-604.01.01-416311
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Cemal Tamer Erel, Prof.
• Phone: +905322946022
• Email: ctamererel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Er:YAG laser is a safe option for the treatment of vulvar pain. Er:YAG 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. Er:YAG 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 Er:YAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain. In this study, the therapeutic effect of Er:YAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain.

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 pain/penetration 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. Er:YAG laser is a safe option for the treatment of vulvar pain. Er:YAG 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. Er:YAG 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 Er:YAG laser will improve the scar tissue of episiotomy and ameliorate the vulvar pain. In this study, the therapeutic effect of Er:YAG laser on the tissue healing of the episiotomy scars and the reduction of vulvar pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Female, 18 years of age or older
• Have given birth in the last 6 months with episiotomy
• Have vulvar pain and dyspareunia

Exclusion Criteria:

• History of connective tissue disease
• History of other diseases that can cause vulvar pain (neurological, dermatological, Infectious etc.)

Related Conditions & MeSH terms

• Episiotomy Wound
• Laser
• Vulvodynia

Intervention

Device:
• Fotona Dynamis Er:YAG Laser System
The patient receives 2940 nm Er:YAG Laser (XS Dynamis, Fotona, Slovenia) at intervals of 15-21 days. She receives 3 sessions, in total. 5% Lidocaine cream is applied 30 minutes before each procedure. Each session consists of application of R11 handpiece to the episiotomy scar at Turbo3 Micro Short Pulse mode, with spot size of 2 mm, fluence of 9.5-10 j/cm2, frequency of 2 Hz and 4 pulses per point and 3 passes followed by PS03 handpiece at Basic Long Pulse mode, with spot size of 5 mm, energy of 800 mJ, frequency of 1.4 Hz and 4 pulses per point and 2 passes.
• Fotona Dynamis Er:YAG Laser System with Sham handpiece
The same procedure is applied above but with a sham handpiece and parameter presentations masked.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)	Fotona d.o.o.

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Rate of change of pain	Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10)	6 months
Primary	Efficacy: Rate of scar tissue healing	Evaluation of the efficacy and safety of scar tissue healing by USG Elastography for fibrosis	6 months
Secondary	Efficacy: Rate of improvement in sexual function	Evaluation of the change of Genital Pelvic Pain by Female Sexual Function Index	6 months
Secondary	Safety: Incidence and severity of device related Adverse Events	Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)	6 months