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

Primary Purpose

Episiotomy Wound, Laser, Vulvodynia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fotona Dynamis Er:YAG Laser System
Fotona Dynamis Er:YAG Laser System with Sham handpiece
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episiotomy Wound focused on measuring Episiotomy; Complications, Er-YAG Laser, Vulvodynia, Vulva Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.)

Sites / Locations

  • Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Fotona Dynamis Er:YAG Laser System Arm

Fotona Dynamis Er:YAG Laser System with Sham handpience

Arm Description

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

The same procedure is applied but with a sham handpiece.

Outcomes

Primary Outcome Measures

Efficacy: Rate of change of pain
Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10)
Efficacy: Rate of scar tissue healing
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
Evaluation of the change of Genital Pelvic Pain by Female Sexual Function Index
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)

Full Information

First Posted
March 20, 2023
Last Updated
April 1, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Fotona d.o.o.
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1. Study Identification

Unique Protocol Identification Number
NCT05793476
Brief Title
Therapeutic Efficacy of Erbium:YAG Laser in Postpartum Patients With Episiotomy Scars
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Fotona d.o.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episiotomy Wound, Laser, Vulvodynia, Vulva Pain
Keywords
Episiotomy; Complications, Er-YAG Laser, Vulvodynia, Vulva Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The participant doesn't know if she receives the sham or laser therapy.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fotona Dynamis Er:YAG Laser System Arm
Arm Type
Experimental
Arm Description
Non-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces
Arm Title
Fotona Dynamis Er:YAG Laser System with Sham handpience
Arm Type
Sham Comparator
Arm Description
The same procedure is applied but with a sham handpiece.
Intervention Type
Device
Intervention Name(s)
Fotona Dynamis Er:YAG Laser System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fotona Dynamis Er:YAG Laser System with Sham handpiece
Intervention Description
The same procedure is applied above but with a sham handpiece and parameter presentations masked.
Primary Outcome Measure Information:
Title
Efficacy: Rate of change of pain
Description
Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10)
Time Frame
6 months
Title
Efficacy: Rate of scar tissue healing
Description
Evaluation of the efficacy and safety of scar tissue healing by USG Elastography for fibrosis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy: Rate of improvement in sexual function
Description
Evaluation of the change of Genital Pelvic Pain by Female Sexual Function Index
Time Frame
6 months
Title
Safety: Incidence and severity of device related Adverse Events
Description
Incidence and severity of device related Adverse Events (i.e., infections, edema, superficial burns, wound dehiscence)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cemal Tamer Erel, Prof.
Phone
+905322946022
Email
ctamererel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ipek B Ozcivit Erkan, MD
Phone
+905322715059
Email
ipekbetulozcivit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cemal Tamer Erel, Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ipek B Ozcivit Erkan, MD
Phone
+905322715059
Email
ipekbetulozcivit@gmail.com
First Name & Middle Initial & Last Name & Degree
Cemal Tamer Erel, Prof
First Name & Middle Initial & Last Name & Degree
Ipek B Ozcivit Erkan, Prof
First Name & Middle Initial & Last Name & Degree
Mert Urfalioglu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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