Pelvic Floor Myofascia: A New Player Involved in Vulvodynia

Healthy Clinical Trial

Official title:

Developing Novel Ultrasound Techniques for Assessing the Pelvic Myofascial Tissues to Investigate Their Involvement in Provoked Vestibulodynia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05350618
• Other study ID #: MP-31-2021-4165
• Status: Completed
• Start date: April 8, 2022
• Est. completion date: May 18, 2023

Study information

• Verified date: June 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Vulvodynia

Intervention

Other:
• Ultrasound evaluation
A single transperineal ultrasound assessment session

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphometry - muscle thickness	Muscle thickness will be measured by transperineal ultrasound in B-mode.	Baseline evaluation
Primary	Viscoelasticity - shear strain	Shear strain will be measured by transperineal ultrasound with elastography.	Baseline evaluation
Primary	Viscoelasticity - shear elastic modulus	Shear elastic modulus be measured by transperineal ultrasound with elastography/shearwave.	Baseline evaluation
Secondary	Pain intensity	To assess pain intensity during intercourse (Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain possible).	Baseline evaluation
Secondary	Pain quality	To assess pain quality including its sensory, affective and evaluative components using the McGill-Melzack pain questionnaire (MPQ). Minimum value: 0, Maximum value: 78, higher scores indicate worse pain.	Baseline evaluation
Secondary	Depression symptoms	To address depressive symptoms according to the Beck Depression Inventory (BDI-II). Minimum value: 0, Maximum value: 63, higher scores indicate more severe depression symptoms.	Baseline evaluation
Secondary	Sexual function	To assess sexual function using the Female Sexual Function Index (FSFI). Minimum value: 2, Maximum value: 36, Inferior scores indicate lower sexual function.	Baseline evaluation
Secondary	Sexual distress	To assess sexual distress (Female Sexual Distress Scale - FSDS). Minimum value: 0, Maximum value: 52, Superior scores indicate higher sexually related distress.	Baseline evaluation
Secondary	Pain catastrophizing	Pain catastrophizing assessed with the Pain Catastrophizing Scale (PCS). Minimum value: 0, Maximum value: 52, Superior scores indicate higher pain catastrophizing.	Baseline evaluation
Secondary	Fear of pain	Fear of pain according to the Pain Anxiety Symptoms Scale (PASS-20). Minimum value: 0, Maximum value: 100, Superior scores indicate higher fear of pain.	Baseline evaluation