Degree project, 30 ECTS [2020-01-19]
Differences between primary and secondary
provoked vestibulodynia
Version 2
Author: Karolina Ågren, MB School of Medical Sciences Örebro University, Örebro, Sweden Supervisor: Linnéa Engman, Center for Health and Medical Psychology
Örebro University, Örebro, Sweden Word count
Abstract: 250 Manuscript: 2542
Abstract
Introduction: Provoked vestibulodynia is a common life impacting disease. Research has shown higher pain intensity and anxiety levels in primary (pain present since first penetrative attempt) provoked vestibulodynia (PVD1) compared to secondary provoked vestibulodynia (PVD2) and mixed results regarding age and female sexual functioning when comparing the groups.
Aim: The aim of this study was to further investigate the differences between PVD1 and PVD2 regarding pain intensity, sexual functioning, age and anxiety levels. The secondary aim was to analyze how PVD group, age, anxiety and pain intensity associates with sexual
functioning.
Method: A total of 57 women from the Netherlands and Sweden were recruited via social media, advertisement and regional caregivers. This study was part of a larger study on cognitive behavioral group therapy for women with provoked vestibulodynia. Data was extracted from a survey assessing intensity of pain, sexual functioning, age and anxiety levels. A t-test was used to compare the PVD1 and PVD2 groups and a multivariate regression analysis was used to analyze the variables association with sexual functioning.
Results: No statistically significant differences were found regarding pain intensity, sexual functioning, age and anxiety levels between PVD1 and PVD2. Decreased sexual functioning was significantly related to higher age and pain intensity.
Conclusion: We found no significant differences between PVD1 and PVD2. Increased age and higher pain intensity seems to associate with lower sexual functioning. Longitudinal studies with a greater sample size are needed for further investigation.
Keywords: provoked vestibulodynia, vulvodynia, female sexual functioning, genital pain, female sexuality.
Abbreviations
CBT: Cognitive behavioral therapy FSFI: Female sexual functioning index
GAD-7: General anxiety disorder questionnaire PVD: Provoked vestibulodynia
PVD1: Primary provoked vestibulodynia PVD2: Secondary provoked vestibulodynia SD: Standard deviation
Introduction
Provoked vestibulodynia (PVD) is defined as chronic vulvar pain where other causes of the pain have been excluded, the pain is present with pressure and is localized in the vestibule of the vaginal entrance[1]. It has been shown that by the age of 40, 8% of women have
experienced symptoms consistent with vestibulodynia (pain on contact that limited or
prevented intercourse lasting more than 6 months)[2]. In another study, 12% of the surveyed women aged 20-59 years reported a history of chronic knife like or excessive pain similar to PVD upon genital contact persisting 3 months or longer[3].
In general, women with vestibulodynia have impaired sexual functioning and higher levels of state and trait anxiety compared to the general population[4]. It has also been shown that women with PVD have lower subjective arousal but the same physiological genital
responsiveness to visual sexual stimuli as control groups[5,6]. Suffering from PVD generally has a negative impact on the woman’s overall quality of life PVD[7], sleep patterns and mental health[8].
Primary provoked vestibulodynia (PVD1) is defined as pain that has been present since the first penetrative attempt[1]. The PVD is classified as secondary (PVD2) if the woman has had pain free intercourse before the pain appeared[1]. Reports on age differences between the groups have been inconsistent with some studies reporting a younger age for those with PVD1[9,10] and others finding no age difference between the groups[11–13]. The ratio between PVD1 and PVD2 seems to be around 50%[14].
Women with PVD1 have been shown to have higher trait anxiety levels[11,15] and anxiety about body exposure during sexual activity than women with PVD2[12,16]. Current treatment recommendations include psychological interventions in combination with pelvic floor
physical therapy and there is support that a multidisciplinary approach is beneficial[17]. However, more studies are needed to investigate if one group might benefit more from one type of treatment than the other. For example if PVD1 has higher levels of anxiety, they might benefit from more anxiety focused interventions like cognitive behavioral therapy (CBT). Women with PVD usually score below cutoff for sexual dysfunction[18]. Studies comparing sexual functioning between PVD1 and PVD2 have shown mixed results[15]. Some studies
found no differences between PVD1 and PVD2 regarding sexual functioning[12,18,19] whereas one study found that women with PVD2 had lower sexual function[13]. Studies investigating the relationship between pain intensity and sexual functioning have had mixed findings, where some studies have found a relation between higher pain intensity and lower sexual functioning[20,21] and others not[22,23], making it questionable whether or not pain treatment alone is enough to enhance sexual functioning.
Women with PVD1 report higher pain intensity during intercourse than women with
PVD2[12,16]. Histological examination of PVD1 pain sites showed higher nerve end density compared with PVD2, whereas pain sites in PVD2 showed more lymphocytes, showing that markers of inflammation differ between the two subgroups[24]. The difference in pathology raises the question whether or not it is appropriate to treat PVD1 and PVD2 in the same way. Some studies have found that remission and treatment outcomes (coital pain improvement) seem to be different between the groups. Women with PVD1 were less likely to report remission than women with PVD2[25,26]. Further understanding of the physiological and psychological mechanisms underlying the different sub groups is necessary to better understand if the groups need different treatment targets.
The aim of this study was to further investigate the differences between PVD1 and PVD2 regarding pain intensity, sexual functioning, age and anxiety levels. The secondary aim was to analyze how PVD group, age, anxiety and pain intensity associate with sexual functioning.
Material and methods
Study design
This cross sectional observational study examined a subset of data from “The Venus study”, a collaborative study between universities in Sweden and the Netherlands (Örebro University, Maastricht University, Amsterdam University and Leiden University). The primary aim of the Venus Study is to examine the effect of cognitive behavioral group therapy on PVD in
women. Ethical approval was given from the regional ethical review board in Uppsala and the medical ethical committee in Leiden-Den Haag-Delft. Participants gave their written consent to participate in the study.
Setting
Participants were recruited via social media, advertisement and regional care givers. In Sweden they were recruited from Västerås and Örebro, in the Netherlands from Leiden, Maastricht and Amsterdam. In the Netherlands advertisement also took place at festivals and in the media. Data was collected between October 2017 – July 2019.
Participants
Participants applied to participate via email and then received written information about the study, ethical considerations and what participation would entail. They were then contacted via telephone by a researcher and a telephone screening interview was conducted, focused on eligibility for the study. If the participant was found eligible she and her partner did a
secondary on site interview answering further questions about her vulvovaginal pain and other possible causes of the pain. During this interview the woman was screened for psychiatric illness via a MINI-International Neuropsychiatric Interview[27] while the partner was not present in the room. In the Netherlands, a gynecological examination was done at a separate meeting after the secondary interview to confirm a PVD diagnosis before inclusion. This difference was because the study took place in a clinical setting in the Netherlands and in an university setting in Sweden.
If the woman was included in the study she answered a baseline survey. It was a 281-item survey examining various parameters of background, pain characteristics and psychological factors.
Figure 1: Flowchart of the recruitment process in Sweden and the Netherlands combined.
Figure 1 displays the recruitment process. 84 women participated in the telephone interview, 22 of them were excluded or withdrew their interest after it and 62 continued to the second interview. 5 women were excluded during the secondary interview and 57 women were included in the study.
Exclusion and inclusion criteria
Inclusion criteria were (i) women aged 18-45 years; (ii) ongoing heterosexual relationship of at least three months; (iii) superficial provoked vulvovaginal pain with no other clear medical cause lasting at least six months; (iv) provoked vulvovaginal pain during or after ≥80% of intercourse attempts and (v) partner agreeing to participate in CBT treatment and in the study. Participants in the Netherlands had an additional inclusion criteria; diagnosis of superficial dyspareunia (defined as pain experienced as superficial pain/pain around the vulvar opening having lasted for more than 6 months during at least 80% of the intercourse attempts) with no apparent ongoing physical cause to the condition. This was based on a gynecological
examination.
Exclusion criteria were (i) unprovoked vulvodynia without the occurrence of dyspareunia; (ii) active infection in the vulva (e.g. yeast infection, fissures, bacterial vaginosis); (iii) current major psychiatric illness (e.g. psychosis, substance use disorder, personality disorder, PTSD with connection to genitals/sexual abuse); (iv) current pregnancy; (v) childbirth within the last
year; (vi) ongoing psychological treatment or evaluation that might interfere with the
treatment of the vulvovaginal pain and (vii) insufficient understanding of Swedish or Dutch.
Classification of PVD1 and PVD2
Participants who answered “Yes” to both “Do you remember your first intercourse experience as being painful” and “If yes, was it the same pain as the one you experience now?” were classified as PVD1. Those who answered “No” to any of those were classified as PVD2.
Sexual functioning
Sexual functioning was assessed with the 19-item Female Sexual Functioning Index (FSFI)[28]. It covers six domains of sexual functioning: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction and sexual pain. It is well recognized for its reliable psychometric properties[29]. It ranges from 2-36, a low score indicates decreased sexual functioning and cut off score for sexual dysfunction is set to 26[30]. The Cronbach’s alpha in this sample was 0.9.
Pain intensity
Pain intensity was assessed using an 11-point visual analogue scale (VAS) where 0 corresponded to no pain and 10 corresponded to the worst pain during intercourse experienced in the last four weeks.
Anxiety
Anxiety was assessed using the Generalized Anxiety Disorder Screener (GAD-7)[31]. It is a 7 item instrument assessing anxiety. It has been shown to be a reliable instrument for measuring anxiety[31]. The items are scored from 0-4 and it ranges from 0-21[25]. A higher score
reflects greater anxiety and a score above 10 is considered within the clinical range of general anxiety disorder[32]. The Cronbach’s alpha for this sample was 0.8.
Statistical methods
To compare the groups an independent t-test was performed. In the variables where the data was not normally distributed, non-parametric tests were performed to validate the results from the t-tests (data not shown). A multivariate regression analysis was performed to analyze
IBM Statistical Package for the Social Sciences (SPSS) version 26 was used to analyze the data.
Results
Participant characteristics
A total number of 57 women were included in the study. Of them 22 (39%) were classified as PVD1 and 35 (61%) as PVD2. Mean age was 27, range 19-41 years. For details see table 1. Table 1: Participant characteristics
Characteristics Total N=57 PVD1 N=22 (39%) PVD2 N=35 (61%) Age – Mean years (range) 27 (19-41) 26 (19-34) 28 (19-41)
Length of relationship, mean years (range)
5.8 (0-15) 4.5 (0-15) 6.5 (0-15) Given birth (% of group total) 12 (21) 2 (9) 10 (29) Years of painful intercourse
(range)
7.5 (0-25) 7.1 (1-18) 7.8 (0-25) Country
The Netherlands N (% group total)
25 (44%) 15 (68) 10 (29)
Sweden – N (% group total) 32 (56%) 7 (32) 25 (71)
Main results
Table 2 shows the mean, standard deviation, t-value and p-value for the variables compared between the groups. No statistically significant differences were found between the groups.
Table 2: Differences between PDV1 and PVD2 based on outcome measures, analyzed with t-test Characteristics Total (N=21) PVD1 (N=21) PVD2 (N=36) t p
Mean SD Mean SD Mean SD
Pain intensity 7 2 7 2 6 2 0.8 0.45
Sexual function 17 6 18 6 16 6 1.5 0.15
Age (years) 27 5 26 4 28 6 -1.6 0.12
Anxiety 3 3 3 3 3 3 -0.8 0.43
Note: Pain intensity – visual analogue scale, range 0-10; Sexual function – female sexual function index (FSFI), range 2-36; Anxiety – general anxiety disorder screener (GAD-7), range 0-21.
Table 3 shows the predictive value that PVD group, age, anxiety and pain intensity had on sexual functioning analyzed with a multivariate regression analysis. Higher age and increased levels of pain intensity had a statistically significant negative impact on sexual functioning. No statistically significant predictive value was found regarding PVD group, age or anxiety. The overall regression model was significant, F(4, 51)=4.4, p=<0.01, R2=0.26.
Table 3: Regression analysis. Dependent variable: Female Sexual Function Index.
Variable Unstandardized beta coefficients - B (standard error) PVD group (PVD2) Age Anxiety Pain intensity -2.3 (1.6) -0.4 (0.1)* 0.2 (0.3) -1.0 (0.4)*
Note: Anxiety – general anxiety disorder screener (GAD-7); Pain intensity – visual analogue scale (VAS) *p=<0.05.
A post hoc power analysis revealed that on the basis of the mean and standard deviation regarding sexual function, between-groups comparison effect size observed in the present study was d=0.33 and a number of approximately 292 participants would be needed to obtain statistical power at 0.80.
Discussion
No significant differences between primary and secondary PVD were found regarding age, pain intensity, sexual functioning and anxiety. This study found that increased age and higher
Previous studies have shown mixed results on whether or not there is a difference between PVD1 and PVD2 regarding sexual functioning and age[9–13,15,18,19]. Other studies have found a significant difference regarding pain intensity[12,16] where this study found none. Although pathological differences have been seen[24], this study confirms that the clinical expression of secondary and primary PVD seem to be much alike, supporting that they can be treated in the same way.
It is not surprising that a negative correlation between age and sexual functioning was found. It is known that female sexual functioning tends to decrease with menopause[33]. However it is interesting to note that this study population had a mean age of 27 and ranged from 19-41 years, which means that most women in this population can be assumed to be premenopausal. A possibly confounding agent is that a higher age could correspond with longer duration of pain, contributing to lower sexual functioning. In hindsight it would have been appropriate to correct for this.
This study found that a higher pain intensity was related to lower sexual functioning. There are previous studies supporting this[20,21], as well as studies showing no such
association[22,23]. Understanding whether or not pain intensity and sexual functioning has a correlation is important in order to determine treatment targets. One study found that group CBT improved sexual functioning to the same degree as vestibulectomy even though the group CBT group did not improve on pain intensity[34]. It is therefore interesting to question if pain itself is the major reason to lower sexual function in women with PVD, or if there are other psychosocial factors that need to be considered. It might be that it is not beneficial to only focus treatment on pain, and instead to choose a biopsychosocial approach to the treatment[35]. This study did find a relation between higher pain intensity and lower sexual functioning, which indicates that pain management is an important part of treating sexual dysfunction in women with PVD. Several studies suggest a more multimodal treatment approach[34,35]. It would be interesting for future studies to investigate the relationship between pain intensity and sexual functioning in primary and secondary PVD separately, to further investigate if there is a difference there. If there is a difference, one group might perhaps benefit more from pain focused treatment than the other.
A weakness in the female sexual functioning index questionnaire is that there is an option to answer “no sexual activity” on several of the items[36]. The reason why the woman has not had any sexual activity is not illuminated which means that a healthy woman, with good sexual functioning, who has not been sexually active the last month, might score similarly to a woman who has not had any sexual activity within the last month because of pain or other issues. This can falsely give a low score. Also, it cannot be known if the reason for not being sexually active is similar within the PVD1 and the PVD2 groups. Ways to counteract this could be to ask for the reason behind the sexual inactivity and or treat the “no sexual activity” responses as missing values.
Different people might rate the same intensity of pain dissimilarly[37]. Since this study did not compare individual answers over time, it cannot be ruled out that the results might be biased by this. Although it can be assumed that the personal variance of estimation in the different groups was similar since the demographics of the groups are alike, thus lowering the risk for this bias.
This study was a sub-study in a longitudinal cognitive behavioral group treatment study. To participate, the women had to make a big commitment over a year. It might be that women with less severe PVD did not have the same motivation to participate, making it questionable if the results of this study can be generalized to include women with less severe symptoms. This study population was rather small and it might be that the insignificant statistical results are because of this. A post hoc analysis of the data suggested a study sample size of 292 participants to reach statistical power at 0.80 when investigating differences regarding sexual function between PVD1 and PVD2. Even though the results of this study suggest that there are no differences between PVD1 and PVD2, further studies with a greater study population and a longitudinal design that also include less severe forms of PVD are needed.
Conclusions
This study showed no differences between PVD1 and PVD2 regarding age, sexual
functioning, anxiety and pain intensity indicating that the clinical expression of the groups is alike and that they might benefit from similar treatment targets. Decreased sexual functioning seems to be related to higher age and higher pain intensity. More longitudinal studies
Acknowledgements
I wish to express my gratitude to Linnéa Engman for all the assistance she provided in the writing of this thesis. I also want to thank all the women who took part in this study for their willingness to share their experiences.
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Underlivssmärta – skiljer den sig åt beroende på när den uppstod?
Denna studie undersökte om det finns någon skillnad mellan underlivssmärta som funnits sedan första försök till penetration och underlivssmärta som uppstått senare.
Underlivssmärtan kallas för provocerad vestibulodyni och uppstår vid beröring av
vaginalöppningen. Denna typ av underlivssmärta är vanlig, det finns studier som visar att 8% av alla kvinnor vid 40 år ålder någon gång upplevt det.
Vi undersökte om det fanns skillnad i ålder, smärtintensitet, sexuell funktion och ångest och vi hittade ingen skillnad mellan grupperna. Tidigare studier har gett skilda resultat, en del säger att det finns en skillnad, andra att det inte.
Den här studien är viktig eftersom att resultaten tidigare har skiljt sig åt. Det finns fakta som tyder på att sjukdomarna skiljer sig åt i hur väl kvinnorna svarar på behandling. Om det skulle gå att bekräfta att det finns en skillnad skulle det kunna vara underlag för att förbättra
behandlingen och särskilja gruppernas behandling.
Vi undersökte också hur den sexuella funktionen påverkas av ålder, smärtintensitet, ångest och vilken typ av provocerad vestibulodyni kvinnan har. Vi såg att högre ålder och högre smärtintensitet hade en negativ inverkan på den sexuella funktionen. Detta är intressant då det kan ge en indikation på vad som är viktigt att ta i beaktning vid val av behandling som kan öka den sexuella funktionen.
Fler studier som tittar på dessa besvär över tid är nödvändiga för att ge mer klarhet till vilken behandling som kan bäst hjälpa dessa kvinnor.
Örebro, Sweden 2019-12-10 Dear editor of Journal of Sexual Medicine,
Please consider the enclosed manuscript “Differences between primary and secondary provoked vestibulodynia” for publication in the Journal of Sexual Medicine.
In this cross-sectional observational study including 57 women from both Sweden and the Netherlands, differences between primary and secondary provoked vestibulodynia regarding sexual functioning, age, pain intensity and anxiety levels were investigated. No significant differences were found between the groups.
We also performed a multivariate regression analysis investigating the relationship between age, pain intensity, anxiety, type of subgroup (primary vs secondary provoked vestibulodynia) and sexual function. We found that higher age and pain intensity had an association with decreased sexual function.
We believe this manuscript is of interest to your readers as previous studies have shown mixed, non-conclusive results. Our manuscript provides information supporting that there is no significant difference between primary and secondary vestibulodynia and that pain treatment is of value to increase sexual function.
This article is our original work, has not previously been published and is not for consideration for publishing elsewhere. All co-authors have given their consent to the publication of this manuscript.
Sincerely,
Karolina Ågren, MB
School of Medical Sciences
Etisk reflektion
Denna studie har etikprövats och fått godkännande både i Sverige och Nederländerna. Den insamlade datan innehåller mycket känslig information om deltagarnas privatliv. Deltagarna fick muntlig och skriftlig information om studien och gav sitt skriftliga medgivande att delta. All data hanterades pseudoanonymiserad utan tillgång till kodnyckel. Datan behandlades och lagrades i enlighet med personuppgiftslagen.
Om skillnader mellan grupperna hade framkommit är det viktigt att ta i beaktande att kvinnan inte blir skuldbelagd för hennes smärta. Det finns stigma kring psykologiska besvär och om det skulle visa sig att kvinnans underlivssmärta är kopplad till det är det viktigt att det inte påverkar hur hon blir bemött.
Riskerna med denna studie är att om resultaten (att det inte verkar finnas någon skillnad mellan primär och sekundär provocerad vestibulodyni och att högre ålder samt smärtintensitet har en negativ inverkan på sexuell funktion) ges för stor vikt och implementeras. Denna studies design var en tvärsnittsobservationsstudie och bör endast ses som indikation för vidare studier. Eftersom flera studier av samma karaktär visat motsägande resultat bör dessa resultats ses i relation till detta. För att kunna dra slutsatser som implementeras i vården bör en annan studiedesign, förslagsvis longitudinella observationsstudier och behandlingsstudier utföras. Det kan ifrågasättas om det är etiskt försvarbart att studera något som redan blivit studerat med liknande studiedesign. Då denna studie var en understudie till en behandlingsstudie kan man försvara det med att data fanns insamlad och att det inte medför något ytterligare lidande för de som deltagit i studien.
