Episiotomy WoundNCT05793476
Therapeutic Efficacy of Erbium:YAG Laser in Postpartum Patients With Episiotomy Scars
A study testing Fotona Dynamis Er:YAG Laser System in people with Episiotomy Wound and Laser, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Episiotomy Wound, Laser, Vulvodynia
- What is being tested?
- Fotona Dynamis Er:YAG Laser System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Female, 18 years of age or older
- Have given birth in the last 6 months with episiotomy
- Have vulvar pain and dyspareunia
Who cannot join
- History of connective tissue disease
- History of other diseases that can cause vulvar pain (neurological, dermatological, Infectious etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34098
About this study
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.
Read the 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.
- Conditions
- Episiotomy Wound, Laser, Vulvodynia, Vulva Pain
- Being tested
- Fotona Dynamis Er:YAG Laser System, Fotona Dynamis Er:YAG Laser System with Sham handpiece
- Keywords
- Episiotomy; Complications, Er-YAG Laser, Vulvodynia, Vulva Pain
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fotona Dynamis Er:YAG Laser SystemDevice
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 with Sham handpieceDevice
The same procedure is applied above but with a sham handpiece and parameter presentations masked.
| Study group | Role | What they receive |
|---|---|---|
| Fotona Dynamis Er:YAG Laser System Arm | Experimental | Non-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces Receives: 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. Receives: Device: Fotona Dynamis Er:YAG Laser System with Sham handpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Rate of change of pain
Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10)
Measured: 6 months
Efficacy: Rate of scar tissue healing
Evaluation of the efficacy and safety of scar tissue healing by USG Elastography for fibrosis
Measured: 6 months
Secondary outcomes (2)
Efficacy: Rate of improvement in sexual function
Evaluation of the change of Genital Pelvic Pain by Female Sexual Function Index
Measured: 6 months
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start4 Aug 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Why it stopped: Not able to find enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy WoundStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Fotona d.o.o.
- Responsible party
- Principal investigator, Cemal Tamer Erel, Istanbul University - Cerrahpasa
- Investigators
- Cemal Tamer Erel, Prof., Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793476
- Sponsor's protocol ID
- E-83045809-604.01.01-416311
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05793476
- Acronym / sponsor ID
- E-83045809-604.01.01-416311
- Conditions
- Episiotomy Wound, Laser, Vulvodynia, Vulva Pain
- Keywords
- Episiotomy; Complications, Er-YAG Laser, Vulvodynia, Vulva Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not able to find enough participants
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Fotona d.o.o.
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fotona Dynamis Er:YAG Laser System Arm | Experimental | Device: Fotona Dynamis Er:YAG Laser SystemNon-ablative thermal-only Er:YAG laser treatment using R11 and PS03 handpieces |
| Fotona Dynamis Er:YAG Laser System with Sham handpience | Sham comparator | Device: Fotona Dynamis Er:YAG Laser System with Sham handpieceThe same procedure is applied but with a sham handpiece. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Female, 18 years of age or older
- Have given birth in the last 6 months with episiotomy
- Have vulvar pain and dyspareunia
Key exclusion criteria (2 listed)
- History of connective tissue disease
- History of other diseases that can cause vulvar pain (neurological, dermatological, Infectious etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fotona Dynamis Er:YAG Laser SystemThe 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. | Device | Fotona Dynamis Er:YAG Laser System Arm |
| Fotona Dynamis Er:YAG Laser System with Sham handpieceThe same procedure is applied above but with a sham handpiece and parameter presentations masked. | Device | Fotona Dynamis Er:YAG Laser System with Sham handpience |
Primary outcome
Efficacy: Rate of change of pain
Time frame: 6 months
Change of vulvar pain in patients with mediolateral episiotomy measured by visual analogue scale (0-10)
Efficacy: Rate of scar tissue healing
Time frame: 6 months
Evaluation of the efficacy and safety of scar tissue healing by USG Elastography for fibrosis
2 secondary outcomes
Efficacy: Rate of improvement in sexual function
Time frame: 6 months
Safety: Incidence and severity of device related Adverse Events
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Not able to find enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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RELIEVE Study- Platelet-Rich Plasma to Reduce Postpartum Pain After Perineal Tears or Episiotomy
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Platelet-Rich Plasma Versus Standard Care for Episiotomy Wound Healing in Postpartum Women
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemal Tamer Erel, Prof. principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fotona Dynamis Er:YAG Laser System in people with Episiotomy Wound and Laser, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not able to find enough participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Rate of change of pain (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.