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

NCT05793476 | Terminated

• 1 other identifier: E-83045809-604.01.01-416311
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Episiotomy Wound; Laser; Vulvodynia; Vulva Pain

Keywords

Episiotomy; Complications; Er-YAG Laser; Vulvodynia; Vulva Pain

Outcome Measures

Primary Outcomes (2)

• Efficacy: Rate of change of pain

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

  6 months

• Efficacy: Rate of scar tissue healing

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

  6 months

Secondary Outcomes (2)

• Efficacy: Rate of improvement in sexual function

  6 months

• Safety: Incidence and severity of device related Adverse Events

  6 months

Study Arms (2)

Fotona Dynamis Er:YAG Laser System Arm

EXPERIMENTAL

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

Device: Fotona Dynamis Er:YAG Laser System

Fotona Dynamis Er:YAG Laser System with Sham handpience

SHAM COMPARATOR

The same procedure is applied but with a sham handpiece.

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

Interventions

Fotona Dynamis Er:YAG Laser System DEVICE

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.

Fotona Dynamis Er:YAG Laser System Arm

Fotona Dynamis Er:YAG Laser System with Sham handpiece DEVICE

The same procedure is applied above but with a sham handpiece and parameter presentations masked.

Fotona Dynamis Er:YAG Laser System with Sham handpience

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Fotona d.o.o.: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vulvodynia

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Cemal Tamer Erel, Prof.

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant doesn't know if she receives the sham or laser therapy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start: August 4, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)