CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
Corticomotor excitability to the pelvic floor muscles +4 moreother
Likely dose
Not stated in record
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Search/NCT04234555
NCT04234555N/ACompleted

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

University of Ottawa·observational·Posted Jan 21, 2020·Updated Apr 4, 2023

In Brief

An observational study evaluating Corticomotor excitability to the pelvic floor muscles, Pelvic floor muscle response to pressure applied at the vulvar vestibule, and 3 other interventions for Dyspareunia. Completed, enrolled 85 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDyspareunia
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 21, 2020
Enrollment StartFeb 2, 2021
Primary CompletionJan 15, 2023
Study CompletionMar 20, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.4 years ago

Interventions

Corticomotor excitability to the pelvic floor musclesother

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.

Pelvic floor muscle response to pressure applied at the vulvar vestibuleother

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.

Pressure pain threshold (PPS)other

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

Temporal summation of painother

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.

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

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.