Ultrasound Evaluation and Vestibular Perception Thresholds Changes in Women Affected by Vestibulodynia (VBD) After One Cycle of Pixel CO2-Alma Fractionated Laser

NCT05156489 | Unknown

• 1 other identifier: SDSV-2020-03.1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vestibulodynia (VBD), term revised by Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia in 2015, is a vulvar pain of at least 3 months' duration, without clear identifiable cause and localized at vestibuli. Women affected by this disease report localized hypersensitivity and pain of the vulvar vestibule to the touch (eg, during sexual intercourse or tampon use). This pattern of responses is suggestive of sensory abnormalities in the form of evoked pain (eg, hyperalgesia or allodynia). Research biopsy studies have demonstrated increased innervation of the vulvar vestibule and increased subepithelial heparinase activity and cytokines that have been associated with neuroinflammatory processes. In addition, the discomfort inherent in VBD is always associated with pelvic floor muscle overactivity, with the development of myofascial trigger points, resulting in localized or radiating pain and/or severe tenderness. A rich nerve plexus was identified within the vaginal submucosa, which was only composed of sympathetic and parasympathetic axons, with contributions of smaller sensory fibers. The sensory nerve endings of the vulvar vestibule are dense and shallow, making this region more physiologically sensitive. Several works suggest that a thinner vestibular mucosa is more sensitive to nociception because nerve endings become more superficial, thus altering the transduction of mechanical pressure to facilitate nociception. The CO2 fractionated laser, has been used to safely and effectively treat symptomatic vaginal atrophy. This tool has also been found to be useful in the treatment of vestibulodynia. In this open pilot study, 30 female subjects aged more 18 years old at inclusion, having symptoms of VBD from at least 6 months, have given her informed consent and meet all the eligibility criteria, will be enrolled. The subjects will be treated with CO2 Fractionated Laser into vestibule, for 3 sessions at monthly intervals with a follow up of 4 months. Subjects will come to a total of 6 visits over a period of 3 months. The primary objectives of the study are to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser in women affected by VBD by the assessment of vestibular mucosa thickness by ultrasound evaluation and vestibular perception thresholds changes at day 84 and 120 and by searching the adverse event during all the study. The secondary objectives are the assessment of VAS for burning/pain, and dyspareunia, evaluation of pain and hypersensitivity to the touch by Swab test, Female Sexual Function Index (FSFI) and by Vulval Pain Functional Questionnaire (VQ) at the visits.

Conditions

Vestibulodynia (VBD) From at Least 6 Months

Keywords

Vestibulodynia (VBD); Fractionated Laser; Vaginal dryness.

Outcome Measures

Primary Outcomes (2)

• Vestibular mucosa thickness measured in µm by B-scan ultrasonography (DermaScan C, Cortex Technology, Denmark)

  The Investigator will use B-scan ultrasonography with a 20-MHz validated system. The changing was evaluated from baseline to day 84 (visit 5), and 120 (final visit).

  120 days

• Vestibular perception thresholds measured with values from 1 to 25 by Neurometer CPT (Neurotron, Inc, Baltimore, MD)

  In Vestibular perception thresholds (VPT) a value ranging from 6 to 13 is classified as normal, while a value ranging from 1 to 5 show hyperesthesia. A value between 14 and 25 shows hypoesthesia. The changing was evaluated from baseline to day 84 (visit 5), and 120 (final visit).

  120 days

Secondary Outcomes (7)

• Dyspareunia by Visual Analogue Scale

  120 days

• Burning/pain by Visual Analogue Scale

  120 days

• Pain/hypersensitivity to the touch at Swab test measured by Visual Analogue Scale.

  120 days

• Sexual Function by Female Sexual Function Index

  120 days

• Vulval pain by Vulval Pain Functional Questionnaire (VQ)

  120 days

Study Arms (1)

Fractionated Laser

EXPERIMENTAL

Device: Fractionated Laser (Pixel CO2-Alma)

Interventions

Fractionated Laser (Pixel CO2-Alma) DEVICE

The Laser will be administered at baseline (visit 2, day 0), at visit 3 (day 28±4) and at visit 4 (day 56±4) into vestibule, following the IFU of the device.

Fractionated Laser

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Women affected by Vestibulodynia (VBD)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women affected by Vestibulodynia (VBD) from 6 months.
• Women older than 18 years and not yet in menopausa period (12 consecutive months without a menstrual period).
• Vulval pain from moderate to severe (in a Likert scale between 0 =absent and 10 =severe, scored at least 5 after sexual intercourse with penetration).
• Pain localized at vestibuli during sexual intercourse or in activities with pressure on vestibuli (ie bike, horsing).
• Willingness to provide informed consent
• Willing to have sexual intercourse in the study period

You may not qualify if:

• Hypersensitivity or intolerance to laser.
• Clinically significant findings on physical examination.
• Any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study.
• Pelvic floor hypertonicity (from moderate to severe) evaluated at screening by the Investigator and scored on a Likert scale between 0 = hypertonicity absent and 3 =severe hypertonicity.
• Active vaginal or vulvar infections (e.g., herpes, candida, STIs)
• Uterine prolapse beyond the hymen.
• Subject has a history of scarring alteration (ie, keloid formation).
• Unknown past or active history of vaginal bleeding disorders.
• Any condition or behavior indicating to the Investigator that the subject is unlikely to be compliant with study procedures and visits.

Sponsors & Collaborators

• Dr. Filippo Murina: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Ospedale dei Bambini "Vittore Buzzi"

Milan, 20154, Italy

Location

Related Publications (8)

• Bornstein J, Goldstein AT, Stockdale CK, Bergeron S, Pukall C, Zolnoun D, Coady D; consensus vulvar pain terminology committee of the International Society for the Study of Vulvovaginal Disease (ISSVD); International Society for the Study of Women's Sexual Health (ISSWSH); International Pelvic Pain Society (IPPS). 2015 ISSVD, ISSWSH, and IPPS Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia. J Sex Med. 2016 Apr;13(4):607-12. doi: 10.1016/j.jsxm.2016.02.167. Epub 2016 Mar 25.

  PMID: 27045260 BACKGROUND

• Goldstein AT, Pukall CF, Brown C, Bergeron S, Stein A, Kellogg-Spadt S. Vulvodynia: Assessment and Treatment. J Sex Med. 2016 Apr;13(4):572-90. doi: 10.1016/j.jsxm.2016.01.020. Epub 2016 Mar 25.

  PMID: 27045258 BACKGROUND

• Wesselmann U, Bonham A, Foster D. Vulvodynia: Current state of the biological science. Pain. 2014 Sep;155(9):1696-1701. doi: 10.1016/j.pain.2014.05.010. Epub 2014 May 22. No abstract available.

  PMID: 24858303 BACKGROUND

• Morin M, Binik YM, Bourbonnais D, Khalife S, Ouellet S, Bergeron S. Heightened Pelvic Floor Muscle Tone and Altered Contractility in Women With Provoked Vestibulodynia. J Sex Med. 2017 Apr;14(4):592-600. doi: 10.1016/j.jsxm.2017.02.012.

  PMID: 28364981 BACKGROUND

• Farmer MA. What is special about the vulvar vestibule? Pain. 2015 Mar;156(3):359-360. doi: 10.1097/j.pain.0000000000000094.

  PMID: 25687538 BACKGROUND

• Murina F, Barbieri S, Lubrano C, Cetin I. Vestibular Mucosa Thickness Measured by Ultrasound in Patients Affected by Vestibulodynia: A Case-Control Study. Sex Med. 2021 Apr;9(2):100320. doi: 10.1016/j.esxm.2020.100320. Epub 2021 Feb 13.

  PMID: 33588370 BACKGROUND

• Salvatore S, Athanasiou S, Candiani M. The use of pulsed CO2 lasers for the treatment of vulvovaginal atrophy. Curr Opin Obstet Gynecol. 2015 Dec;27(6):504-8. doi: 10.1097/GCO.0000000000000230.

  PMID: 26536212 BACKGROUND

• Murina F, Karram M, Salvatore S, Felice R. Fractional CO2 Laser Treatment of the Vestibule for Patients with Vestibulodynia and Genitourinary Syndrome of Menopause: A Pilot Study. J Sex Med. 2016 Dec;13(12):1915-1917. doi: 10.1016/j.jsxm.2016.10.006. Epub 2016 Nov 15.

  PMID: 27864031 BACKGROUND

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

Central Study Contacts

Filippo Murina, MD

CONTACT

+390263635420; filippo.murina@asst-fbf-sacco.it

Dioniso F Barattini, MD

CONTACT

+40774012684; franco.barattini@tigermedgrp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Pathology Service of the lower genital tract

Model Details: Pilot open not comparative

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: December 14, 2021
• Study Start: January 30, 2022
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

IT (1)