Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
NCT Number: NCT05350618
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.
Looking for future studies?
Notify Me18 year–45 year
Female
Observational
Sherbrooke, Quebec, J1H 5N4, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single transperineal ultrasound assessment session
Time frame: Baseline evaluation
Muscle thickness will be measured by transperineal ultrasound in B-mode.
Time frame: Baseline evaluation
Shear strain will be measured by transperineal ultrasound with elastography.
Time frame: Baseline evaluation
Shear elastic modulus be measured by transperineal ultrasound with elastography/shearwave.
Time frame: Baseline evaluation
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).
Time frame: Baseline evaluation
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.
Time frame: Baseline evaluation
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.
Time frame: Baseline evaluation
To assess sexual function using the Female Sexual Function Index (FSFI). Minimum value: 2, Maximum value: 36, Inferior scores indicate lower sexual function.
Time frame: Baseline evaluation
To assess sexual distress (Female Sexual Distress Scale - FSDS). Minimum value: 0, Maximum value: 52, Superior scores indicate higher sexually related distress.
Time frame: Baseline evaluation
Pain catastrophizing assessed with the Pain Catastrophizing Scale (PCS). Minimum value: 0, Maximum value: 52, Superior scores indicate higher pain catastrophizing.
Time frame: Baseline evaluation
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.
Université de Sherbrooke
Other
Developing Novel Ultrasound Techniques for Assessing the Pelvic Myofascial Tissues to Investigate Their Involvement in Provoked Vestibulodynia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06967714
Behavior, Healthy
Brussels, Belgium
View Trial DetailsNCT06336109
Healthy, Mental Disorders
Aalborg, North Denmark, Denmark
View Trial DetailsNCT06330402
Healthy, Neurologic Manifestations
Aalborg, North Denmark, Denmark
View Trial DetailsNCT04299490
Agnosia, Apnea
Baltimore, Maryland, United States
View Trial Details