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

I

Istanbul University - Cerrahpasa

Status

Terminated

Conditions

Episiotomy Wound
Vulva Pain
Laser
Vulvodynia

Treatments

Device: Fotona Dynamis Er:YAG Laser System
Device: Fotona Dynamis Er:YAG Laser System with Sham handpiece

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05793476
E-83045809-604.01.01-416311

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

5 participants in 2 patient groups

Fotona Dynamis Er:YAG Laser System Arm
Experimental group
Description:
Non-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces
Treatment:
Device: Fotona Dynamis Er:YAG Laser System
Fotona Dynamis Er:YAG Laser System with Sham handpience
Sham Comparator group
Description:
The same procedure is applied but with a sham handpiece.
Treatment:
Device: Fotona Dynamis Er:YAG Laser System with Sham handpiece

Trial contacts and locations

1

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Central trial contact

Ipek B Ozcivit Erkan, MD; Cemal Tamer Erel, Prof.

Data sourced from clinicaltrials.gov

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