What is the Nature of Pelvic Floor Muscle Involvement in Dyspareunia?

NCT04234555 | Completed

• 1 other identifier: H-11-18-1183
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Dyspareunia, or pain experienced by women during penetrative sexual activities, affects the psychological and sexual health of more than one in five Canadian women \[1\], yet its pathophysiology is poorly understood \[2-4\] and evidence for management approaches is limited.\[5\] It is thought that pelvic floor muscle (PFM) dysfunction is implicated in many forms of dyspareunia, while the nature and aetiology of this involvement remain largely unknown. The goal of this study is to understand if and how PFM dysfunction contributes to the pain experienced by women with provoked vestibulodynia (PVD), the most common cause of dyspareunia. This goal will be achieved through implementing an innovative and comprehensive approach to measuring the neuromuscular function of the PFMs. Understanding the pathophysiology of PVD is essential to the development of effective interventions to improve the health and quality of life of the many Canadian women who suffer from dyspareunia.

Conditions

Dyspareunia

Keywords

dyspareunia; electromyography; transcranial magnetic stimulation; pressure pain threshold; temporal summation; vaginismus; provoked vestibulodynia

Outcome Measures

Primary Outcomes (5)

• Motor evoked potential (MEP) peak to peak amplitude (µV)

  Transcranial magnetic stimulation outcome (i.e. Motor evoked potential peak to peak amplitude - µV) will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double cone coil (96 mm loops, P/N 9902) \[57\] will be used to probe the corticospinal projections to PFMs. MEPs will be ensemble averaged to generate estimates of MEP peak to peak amplitude (µV).

  1 day

• Cortical silent period duration (ms)

  Transcranial magnetic stimulation outcome (i.e. cortical silent period duration - ms) will be determined for all participants and compared among groups. A Magstim® 200 system coupled with a double cone coil (96 mm loops, P/N 9902) \[57\] will be used to probe the corticospinal projections to PFMs. MEP cortical silent period (cSP) will be measured from individual trials and then averaged.

  1 day

• Anticipatory responses (ms)

  The proportion of women in each group who demonstrate anticipatory responses of the PFMs to impending pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have anticipatory responses if electromyographic signals recorded from the PFMs precede the application of pressure. A vulvalgesiometer \[58\] will be employed using a response-dependent methodology. \[59,60\] The vulvalgesiometer will be used to apply low (25 g) and moderate (232 g) pressures to the posterior vaginal fourchette or to the posterior thigh, the moderate value having been generated through the team's previous research. \[9\]

  1 day

• Behavioural responses (µV)

  The proportion of women in each group who demonstrate behavioral responses of the PFMs to pressure applied at the vulvar vestibule will be determined for each group. Participants will be deemed to have behavioural if the activation of the PFMs (or other muscles) occurs after the pressure is applied. A vulvalgesiometer \[58\] will be employed using a response-dependent methodology. \[59,60\] The vulvalgesiometer will be used to apply low (25 g) and moderate (232 g) pressures to the posterior vaginal fourchette or to the posterior thigh, the moderate value having been generated through the team's previous research. \[9\]

  1 day

• Tonic, phasic and reflex activation of the pelvic floor muscles

  Surface Electromyography (EMG) recorded using differential suction electrodes (DSEs, developed by Dr. McLean) \[54-56\] will be used to measure tonic, voluntary and reflex activation of the superficial and deep PFMs. Smoothed peak EMG amplitudes (µV) will be computed as outcomes while women keep their PFMs as relaxed as possible (tonic), contract as strongly as possible (phasic) and perform a straining maneuver (reflex activation).

  1 day

Secondary Outcomes (3)

• Tampon test

  1 day

• Pressure pain threshold (PPT)

  1 day

• Temporal summation (TS) of pain

  1 day

Other Outcomes (5)

• Female sexual function index (FSFI)

  1 day

• McGill Pain Questionnaire

  1 day

• Pain catastrophizing scale

  1 day

Study Arms (3)

Provoked vestibulodynia (PVD)

Provoked vestibulodynia (PVD) is characterized by severe sharp and/or burning pain felt at the entrance to the vagina (i.e. the vulvar vestibule) when pressure is applied to this area or during attempts at vaginal insertional activities (i.e. provoked).

Diagnostic Test: Corticomotor excitability to the pelvic floor muscles; Diagnostic Test: Pelvic floor muscle response to pressure applied at the vulvar vestibule; Diagnostic Test: Pressure pain threshold (PPS); Diagnostic Test: Temporal summation of pain; Diagnostic Test: Tonic, phasic and reflex activation of the pelvic floor muscles (PFMs)

Provoked vestibulodynia (PVD) + Vaginismus (VAG)

PVD is sometimes accompanied by intense, involuntary contraction of the PFMs3, termed vaginismus (VAG).

Diagnostic Test: Corticomotor excitability to the pelvic floor muscles; Diagnostic Test: Pelvic floor muscle response to pressure applied at the vulvar vestibule; Diagnostic Test: Pressure pain threshold (PPS); Diagnostic Test: Temporal summation of pain; Diagnostic Test: Tonic, phasic and reflex activation of the pelvic floor muscles (PFMs)

Control

Participants matched by age (within 2 years), parity (parous vs nulliparous) and use of oral contraceptive medications (yes vs no) to women in the PVD group, with no signs and symptoms of PVD.

Diagnostic Test: Corticomotor excitability to the pelvic floor muscles; Diagnostic Test: Pelvic floor muscle response to pressure applied at the vulvar vestibule; Diagnostic Test: Pressure pain threshold (PPS); Diagnostic Test: Temporal summation of pain; Diagnostic Test: Tonic, phasic and reflex activation of the pelvic floor muscles (PFMs)

Interventions

Corticomotor excitability to the pelvic floor muscles DIAGNOSTIC_TEST

Transcranial magenetic stimulation will be used to probe the excitability of cortical projections to the pelvic floor muscles. The outcomes of interest will include motor evoked potential amplitude and silent period.

Control; Provoked vestibulodynia (PVD); Provoked vestibulodynia (PVD) + Vaginismus (VAG)

Pelvic floor muscle response to pressure applied at the vulvar vestibule DIAGNOSTIC_TEST

Electromyography will be used to determine whether the pelvic floor muscles (PFMs) respond to pressure applied to the vulvar vestibule as anticipatory (i.e. PFMs are active before the pressure is applied) and as behavioural (i.e. PFMs are active after the pressure is applied) responses. The amplitude of the EMG responses will also be recorded.

Control; Provoked vestibulodynia (PVD); Provoked vestibulodynia (PVD) + Vaginismus (VAG)

Pressure pain threshold (PPS) DIAGNOSTIC_TEST

A custom vulvalgesiometer will be used to determine the mean pressure at which participants first report pain at the posterior vaginal fourchette.

Control; Provoked vestibulodynia (PVD); Provoked vestibulodynia (PVD) + Vaginismus (VAG)

Temporal summation of pain DIAGNOSTIC_TEST

A custom vulvalgesiometer will be used to apply the same pressure (rated as 4/10 duiring PPS testing as described above) to the vulvar vestibule across 10 repetitions. The difference in pain rated on the tenth application and that rated on the first application will be the outcome.

Control; Provoked vestibulodynia (PVD); Provoked vestibulodynia (PVD) + Vaginismus (VAG)

Tonic, phasic and reflex activation of the pelvic floor muscles (PFMs) DIAGNOSTIC_TEST

Electromyography will be used to measure the mean smoothed, rectified activation amplitude across 1 second of complete rest, across three maximal effort PFM contractions, and across three attempts at a bearing down maneuver.

Control; Provoked vestibulodynia (PVD); Provoked vestibulodynia (PVD) + Vaginismus (VAG)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Females with PVD alone or PVD+ VAG will be recruited at the vulvar pain clinic at The Ottawa Hospital and from local physiotherapy clinics that cater to females with pelvic floor dysfunction. Control participants will be recruited from the local community through advertisements, word of mouth and social media.

You may qualify if:

• Premenopausal women over the age of 18
• Biologically born female
• Signs and symptoms consistent with Provoked Vestibulodynia (PVD) alone or PVD+ Vaginismus (VAG) (i.e. evidence of a vaginal muscle spasm in response to palpation) or no history of pain during sexual activities or tampon insertion to serve as a comparison group
• Not currently pregnant, or pregnant in the past six months.

You may not qualify if:

• Neurological condition such as stroke, multiple sclerosis, spinal cord injury, epilepsy, or history of epilepsy in the family, etc
• Metal implants (cochlear, pacemaker, etc.)
• Tendency to faint
• in Peri- or post-menopause
• express high levels of anxiety about the assessment protocol

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

Flavia Antonio

Ottawa, Ontario, K1N 6N5, Canada

Location

Related Publications (60)

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MeSH Terms

Conditions

Dyspareunia; Vaginismus

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vaginal Diseases

Study Officials

• Linda McLean

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the School of Rehabilitation Sciences at the University of Ottawa.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 21, 2020
• Study Start: February 2, 2021
• Primary Completion: January 15, 2023
• Study Completion: March 20, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for 10 years after the publication of the study results.
• Access Criteria: Planned use of data for systematic review.

Locations

CA (1)