An interventional study of Fotona Dynamis Er:YAG Laser System and Fotona Dynamis Er:YAG Laser System with Sham handpiece in Episiotomy Wound, Laser and Vulvodynia, sponsored by Istanbul University - Cerrahpasa. Terminated at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Vulvodynia; 20 are open to participants now.
This study's enrollment of 5 is below the median of 45 across 78 interventional studies indexed under Vulvodynia.
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Exclusion Criteria:
Non-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces
Device: Fotona Dynamis Er:YAG Laser System
The same procedure is applied but with a sham handpiece.
Device: Fotona Dynamis Er:YAG Laser System with Sham handpiece
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.
The same procedure is applied above but with a sham handpiece and parameter presentations masked.
Efficacy: Rate of change of pain
Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10)
Time frame: 6 months
Efficacy: Rate of scar tissue healing
Evaluation of the efficacy and safety of scar tissue healing by USG Elastography for fibrosis
Time frame: 6 months
Efficacy: Rate of improvement in sexual function
Evaluation of the change of Genital Pelvic Pain by Female Sexual Function Index
Time frame: 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)
Time frame: 6 months
Plan to share: No
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Istanbul University - Cerrahpasa