Therapeutic Efficacy of Erbium:YAG Laser in Postpartum Patients With Episiotomy Scars
Study Details
Study Description
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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fotona Dynamis Er:YAG Laser System Arm Non-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces |
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.
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| Sham Comparator: Fotona Dynamis Er:YAG Laser System with Sham handpience The same procedure is applied but with a sham handpiece. |
Device: Fotona Dynamis Er:YAG Laser System with Sham handpiece
The same procedure is applied above but with a sham handpiece and parameter presentations masked.
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Outcome Measures
Primary Outcome Measures
- Efficacy: Rate of change of pain [6 months]
Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10)
- Efficacy: Rate of scar tissue healing [6 months]
Evaluation of the efficacy and safety of scar tissue healing by USG Elastography for fibrosis
Secondary Outcome Measures
- Efficacy: Rate of improvement in sexual function [6 months]
Evaluation of the change of Genital Pelvic Pain by Female Sexual Function Index
- Safety: Incidence and severity of device related Adverse Events [6 months]
Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult Female, 18 years of age or older
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Have given birth in the last 6 months with episiotomy
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Have vulvar pain and dyspareunia
Exclusion Criteria:
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History of connective tissue disease
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History of other diseases that can cause vulvar pain (neurological, dermatological, Infectious etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istanbul University-Cerrahpasa | Istanbul | Turkey | 34098 |
Sponsors and Collaborators
- Istanbul University - Cerrahpasa (IUC)
- Fotona d.o.o.
Investigators
- Principal Investigator: Cemal Tamer Erel, Prof., Istanbul University - Cerrahpasa (IUC)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E-83045809-604.01.01-416311