Clinical trial NCT05350618: Pelvic Floor Myofascia: A New Player Involved in Vulvodynia
Official title: Developing Novel Ultrasound Techniques for Assessing the Pelvic Myofascial Tissues to Investigate Their Involvement in Provoked Vestibulodynia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Vulvodynia
Keywords: Fascia
Pelvic floor
Provoked vestibulodynia
Pain
Sexual dysfunctions
Ultrasound
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asymptomatic controls (without any vulvar pain) and women suffering from provoked vestibylodynia (moderate to severe pain for at least 90% of the time when engaging in or attempting sexual intercourse) are being recruited.

Brief summary: This study aims to develop novel ultrasound evaluation techniques to characterize the different pelvic myofascial tissues and to examine the intra- and inter-rater reliability of these techniques (objective 1). Moreover, the potential contribution of the pelvic myofascial tissues to the etiology of provoked vestibulodynia will be investigated by comparing the ultrasound data of women with provoked vestibulodynia to that of asymptomatic controls (objective 2). Women interested in participating in the study will contact the research assistant for a screening interview over the phone. Eligible women will then be invited to take part in a pelvic floor ultrasound assessment session at the Urogynecology Research Laboratory. For the first objective, asymptomatic controls will be evaluated by two independent physiotherapists with an expertise in pelvic floor rehabilitation. Intra- and inter-rater reliability of ultrasound data will be analyzed. For the second objective, asymptomatic controls and women with a diagnosis of provoked vestibulodynia will be evaluated by an expert physiotherapist specialized in pelvic floor rehabilitation. Differences in ultrasound data between the two groups will be analyzed.

Detailed description: Vulvodynia, chronic vulvar pain, is identified as a neglected condition by the World Health Organization and the National Institutes of Health. This is explained by a poor understanding of the pathology and compromised diagnosis, leading to poor therapeutic management and a lack of effective treatment options. Provoked vestibulodynia, characterized by pain at the entry of the vagina elicited by pressure and penetration, is the leading subtype of vulvodynia. Recent scientific advances have highlighted the importance of the pelvic floor muscles and the potential role of the surrounding connective tissues (the fascias). Therefore, a new potential contributor is emerging in the etiology of provoked vestibulodynia, namely the pelvic myofascial tissues. The first objective of this study is to develop transperineal ultrasound evaluation techniques (B-mode and ultrasound elastography/shearwave) to assess the morphometry (thickness) and viscoelasticity (shear strain and shear elastic modulus) of the pelvic myofascial tissues and to examine the intra- and inter-rater reliability in asymptomatic controls. The second objective of this study is to examine the potential contribution of the pelvic myofascial tissues to the etiology of provoked vestibulodynia. To do this, morphometric (thickness) and viscoelastic (shear strain and shear elastic modulus) ultrasound imaging features of the pelvic myofascial structures will be compared in women with provoked vestibulodynia and asymptomatic controls. The association between ultrasound data and clinical characteristics will also be investigated. The clinical characteristics will include self-administered psychosexual questionnaires.

Eligibility criteria: Inclusion Criteria:

* No pain during sexual intercourse (for the healthy women)
* Moderate to severe pain (≥ 5/10) during sexual intercourse for at least 3 months (for women with provoked vestibulodynia)
* Moderate to severe pain (≥ 5/10) at least 90% of the time when engaging in or attempting sexual intercourse for at least 3 months (for women with provoked vestibulodynia)

Exclusion Criteria:

* Current or past pregnancy
* Urogynecological condition (e.g., pelvic organ prolapse stage ≥ 3, urinary leakage, current urinary/vaginal infection or in the last 3 months)
* Other causes of vulvo-vaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
* Post-menopausal state
* Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, pelvic organ prolapse surgery)
* Physiotherapy within the last 9 months
* More than 3 physiotherapy treatment within last year
* Medication that could influence pain perception (e.g., analgesic, antidepressant)
* Other medical conditions that could interfere with the study

Primary outcomes:
measure: Morphometry - muscle thickness
timeFrame: Baseline evaluation
measure: Viscoelasticity - shear strain
timeFrame: Baseline evaluation
measure: Viscoelasticity - shear elastic modulus
timeFrame: Baseline evaluation
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline evaluation
measure: Pain quality
timeFrame: Baseline evaluation
measure: Depression symptoms
timeFrame: Baseline evaluation
measure: Sexual function
timeFrame: Baseline evaluation
measure: Sexual distress
timeFrame: Baseline evaluation
measure: Pain catastrophizing
timeFrame: Baseline evaluation
measure: Fear of pain
timeFrame: Baseline evaluation
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
References: