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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Episiotomy Wound, Laser, Vulvodynia, Vulva Pain

Intervention / Treatment
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* Device: Fotona Dynamis Er:YAG Laser System
* Device: Fotona Dynamis Er:YAG Laser System with Sham handpiece


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fotona Dynamis Er:YAG Laser System Arm<br>Non-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces | Device: Fotona Dynamis Er:YAG Laser System<br>* 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.<br>|
| Sham Comparator: Fotona Dynamis Er:YAG Laser System with Sham handpience<br>The same procedure is applied but with a sham handpiece. | Device: Fotona Dynamis Er:YAG Laser System with Sham handpiece<br>* The same procedure is applied above but with a sham handpiece and parameter presentations masked.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Rate of change of pain | Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10) | 6 months | 
| Efficacy: Rate of scar tissue healing | Evaluation of the efficacy and safety of scar tissue healing by USG Elastography for fibrosis | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Rate of improvement in sexual function | Evaluation of the change of Genital Pelvic Pain by Female Sexual Function Index | 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Episiotomy; Complications, Er-YAG Laser, Vulvodynia, Vulva Pain