Ultrasound Evaluation and Vestibular Perception Thresholds Changes in Women Affected by Vestibulodynia (VBD) After One Cycle of Pixel CO2-Alma Fractionated Laser
NCT ID: NCT05156489
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2022-01-30
2022-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fractionated Laser
Fractionated Laser (Pixel CO2-Alma)
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.
Interventions
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Fractionated Laser (Pixel CO2-Alma)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
55 Years
FEMALE
Yes
Sponsors
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Opera CRO, a TIGERMED Group Company
OTHER
Dr. Filippo Murina
OTHER
Responsible Party
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Dr. Filippo Murina
Head of the Pathology Service of the lower genital tract
Locations
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Ospedale dei Bambini "Vittore Buzzi"
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Filippo Murina Murina
Role: primary
References
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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.
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.
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.
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.
Farmer MA. What is special about the vulvar vestibule? Pain. 2015 Mar;156(3):359-360. doi: 10.1097/j.pain.0000000000000094.
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.
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.
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.
Other Identifiers
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SDSV-2020-03.1
Identifier Type: -
Identifier Source: org_study_id