跳至主要内容
临床试验/NCT05793476
NCT05793476终止不适用

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

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2022年8月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
5
试验地点
2
主要终点
Efficacy: Rate of change of pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The participant doesn't know if she receives the sham or laser therapy.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult Female, 18 years of age or older
  • Have given birth in the last 6 months with episiotomy
  • Have vulvar pain and dyspareunia

排除标准

  • History of connective tissue disease
  • History of other diseases that can cause vulvar pain (neurological, dermatological, Infectious etc.)

研究组 & 干预措施

Fotona Dynamis Er:YAG Laser System Arm

Experimental

Non-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces

干预措施: Fotona Dynamis Er:YAG Laser System (Device)

Fotona Dynamis Er:YAG Laser System with Sham handpience

Sham Comparator

The same procedure is applied but with a sham handpiece.

干预措施: Fotona Dynamis Er:YAG Laser System with Sham handpiece (Device)

结局指标

主要结局

Efficacy: Rate of change of pain

时间窗: 6 months

Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10)

Efficacy: Rate of scar tissue healing

时间窗: 6 months

Evaluation of the efficacy and safety of scar tissue healing by USG Elastography for fibrosis

次要结局

  • Efficacy: Rate of improvement in sexual function(6 months)
  • Safety: Incidence and severity of device related Adverse Events(6 months)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cemal Tamer Erel

Clinical Professor

Istanbul University - Cerrahpasa

研究点 (2)

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