Pelvic Floor Myofascia: A New Player Involved in Vulvodynia

NCT05350618 | Completed

• 1 other identifier: MP-31-2021-4165
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Vulvodynia

Keywords

Fascia; Pelvic floor; Provoked vestibulodynia; Pain; Sexual dysfunctions; Ultrasound

Outcome Measures

Primary Outcomes (3)

• Morphometry - muscle thickness

  Muscle thickness will be measured by transperineal ultrasound in B-mode.

  Baseline evaluation

• Viscoelasticity - shear strain

  Shear strain will be measured by transperineal ultrasound with elastography.

  Baseline evaluation

• Viscoelasticity - shear elastic modulus

  Shear elastic modulus be measured by transperineal ultrasound with elastography/shearwave.

  Baseline evaluation

Secondary Outcomes (7)

• Pain intensity

  Baseline evaluation

• Pain quality

  Baseline evaluation

• Depression symptoms

  Baseline evaluation

• Sexual function

  Baseline evaluation

• Sexual distress

  Baseline evaluation

Study Arms (2)

Asymptomatic controls

A single transperineal ultrasound assessment session will be conducted by two independent physiotherapists with an expertise in pelvic floor rehabilitation

Other: Ultrasound evaluation

Women with provoked vestibulodynia

A single transperineal ultrasound assessment session will be conducted by one physiotherapist with an expertise in pelvic floor rehabilitation

Other: Ultrasound evaluation

Interventions

Ultrasound evaluation OTHER

A single transperineal ultrasound assessment session

Asymptomatic controls; Women with provoked vestibulodynia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Vulvodynia; Pain

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher and Full Professor

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 28, 2022
• Study Start: April 8, 2022
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CA (1)