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
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.
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.) |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University-Cerrahpasa | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) | Fotona d.o.o. |
Turkey,
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 |
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