Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia
Condition: Vulvodynia; Dyspareunia; Vestibulodynia
MeSH terms: Dyspareunia; Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      Chronic pain problems involving the female reproductive system are major health concerns for
      all women. Poorly understood, they entail great personal and financial cost. One such
      condition is vulvodynia, or chronic unexplained vulvar pain, which has a prevalence of 16%.
      Despite its negative impact on psychosexual and relationship satisfaction, there is little
      research examining empirically-tested treatments for afflicted couples. The proposed research
      builds on findings from our work focusing on the impact of relational factors on vulvodynia,
      and our previous research evaluating the efficacy of group cognitive-behavioral therapy for
      this problem. This two-centre randomized clinical trial aims to assess the efficacy of a
      novel, 12-week targeted couple therapy (CBCT) for women with vulvodynia in comparison to one
      of the most commonly prescribed first line medical interventions, topical lidocaine. Primary
      research question: Is there a significant difference between the two treatments on women's
      pain during intercourse post-treatment? Secondary research questions will assess for
      significant differences between the two treatments post-treatment and at 6-month follow-up on
      multidimensional aspects of pain using the McGill Pain Questionnaire, women and partners'
      sexuality (sexual function and satisfaction), psychological adjustment (anxiety, depression,
      catastrophizing, self-efficacy, attributions, and quality of life), relationship factors
      (partner responses, couple satisfaction, attachment, and communication styles), and
      self-reported improvement and treatment satisfaction. Results of this study will improve the
      health and quality of life of patients with vulvodynia by rigorously testing the efficacy of
      a novel couples treatment.
    

Detailed description: 
      Background: Chronic pain problems involving the female reproductive system are major health
      concerns in women of all ages. As conditions which are poorly understood and often
      misdiagnosed or ignored, they entail a great personal cost to patients and a significant
      financial cost to society. One such condition is vulvodynia, or chronic unexplained vulvar
      pain. A recent population-based study suggests that the lifetime cumulative incidence of
      vulvodynia is 16%, indicating that approximately 2.5 million Canadian women may experience
      idiopathic vulvar pain during their lifetimes. Provoked vestibulodynia (PVD) - an acute
      recurrent pain localized within the vulvar vestibule and experienced primarily during sexual
      intercourse - is suspected to be the most frequent cause of vulvodynia in premenopausal
      women, with prevalence estimates of 12% in community samples. Despite its high prevalence and
      negative impact on psychosexual functioning, there has been a paucity of controlled research
      to provide empirically validated treatments for afflicted couples. The present proposal draws
      on our previous cross-sectional and prospective CIHR funded research on the dyadic
      determinants of pain and psychosexual impairment in women with PVD and their partners, as
      well as on our past randomized trials evaluating the efficacy of group cognitive-behavioral
      therapy for this condition. Specifically, the goal of our study is to evaluate the efficacy
      of a targeted cognitive-behavioral couple therapy (CBCT) intervention that we developed for
      the treatment of PVD.

      Objectives: The proposed two-centre randomized clinical trial aims to evaluate the efficacy
      of a novel 12-week targeted couple therapy intervention (CBCT) for women with PVD in
      comparison to one of the most frequently prescribed first line medical interventions, topical
      lidocaine, shown to be effective and safe in the management of PVD. The primary research
      question focuses on whether there is a significant difference between the two treatments on
      women's pain during intercourse post-treatment. Secondary research questions focus on whether
      there are significant differences between the two treatments post-treatment and at 6-month
      follow-up on (a) the multidimensional aspects of women's pain on the McGill Pain
      Questionnaire and (b) women and partners' sexuality (sexual function and satisfaction,
      frequency of intercourse), psychological adjustment (anxiety, depression, catastrophizing,
      self-efficacy, pain attributions, quality of life, acceptance of pain, compassionate love for
      partner, self-compassion, emotion regulation and thoughts and feelings related to pain
      experience), relationship factors (partner responses, dyadic adjustment, attachment, and
      communication) and self-reported improvement and treatment satisfaction. We will also examine
      whether childhood trauma and co-morbid pain conditions moderate treatment response. Finally,
      a third research question is to evaluate the role of hormonal contraceptive use and the risk
      of PVD.

      Research plan/methodology: The proposed research is a 3.5-year, two-centre parallel
      randomized controlled trial for PVD using an intent-to-treat analysis strategy, with pain
      during intercourse as the primary outcome. The main research questions will be addressed by:
      1) recruiting 224 premenopausal women and their partners with medically diagnosed PVD; 2)
      performing comprehensive gynecological and psychosexual pre-treatment evaluations focusing on
      our outcome measures; 3) randomly assigning women to one of the two 12-week treatment arms:
      CBCT or lidocaine, and 4) evaluating pain during intercourse, as well as sexual,
      psychological and relationship outcomes, in addition to self-reported improvement and
      treatment satisfaction, post-treatment and at 6-month follow-up. These procedures will take
      place in two different university centers: Université de Montréal in Montréal, Québec, and
      Dalhousie University in Halifax, Nova Scotia, and their affiliated hospitals. Both university
      centres will store data securely, adhering to the protocols outlined by the ethics review
      boards at each site.

      Statistical Analyses: Analyses will be conducted based on intention to treat. Descriptive
      statistics will be used to define and compare the participants in both intervention groups.
      More specifically, we will calculate means, medians, deviations and interquartile ranges and
      T-tests will be used to determine the differences between groups for socio-demographic
      variables. Chi-square tests and observed differences between groups will be used for
      categorical variables. If differences are observed between groups, these variables will be
      controlled for in subsequent analyses. We will verify that variables are normally
      distributed. If variables are not normally distributed, non-parametric tests will be
      employed. A repeated measures analysis of variance will permit the assessment of efficacy of
      the two treatments at post-treatment and at 6-month follow-up. The analyses will focus on the
      changes in pain experienced during intercourse from pre-treatment assessment to
      post-treatment and 6-months follow-up. To do this, time will be the intra-subject variable,
      and the experimental condition will be the inter-subject variable.

      For secondary analysis, multiple analyses will be conducted in multiple steps, with
      multivariate analyses being conducted first for repeated measures (MANOVA). Correlated
      measures will be grouped based on conceptual domain (e.g., pain, dyadic adjustment,
      catastrophizing). Univariate analyses will be conducted if the multivariate results are
      significant (ANOVA). This will be followed by orthogonal contrasts to examine changes between
      different measurements. Moreover, we will use exploratory analyses for participants who
      completed the experimental protocol to determine the effect protocol adherence has on
      treatment efficacy. Multiple regression analyses will be used to examine the link between
      socio-demographic variables, pre-treatment dependent variables and pain at post-treatment and
      6-months follow-up to identify factors associated with therapeutic success. These latter
      analyses will be conducted for each treatment group separately. Bonferroni corrections will
      be used during analyses for multiple comparison adjustments. In the case of missing data, we
      will explore the effects of withdrawal on sensitivity analyses, replace the missing data with
      data from the most recent assessment or with averaged or aggregate values.

      Significance of study: Results of the proposed research may improve the health and quality of
      life of Canadians afflicted with a highly prevalent and neglected women's health problem -
      vulvodynia - by providing a rigorous test of the efficacy of a novel targeted couple therapy
      intervention.
    

Intervention name(s): Cognitive Behavioral Couple Therapy; Topical Lidocaine
Intervention type(s): Behavioral; Other
Intervention description(s): CBCT includes the following: (1) re-conceptualize PVD as a multidimensional pain problem influenced by a variety of factors including thoughts, emotions, behaviors and couple interactions; (2) re-conceptualize PVD as a couple problem in which both members of the couple affect and are affected by the pain; (3) modify those factors associated with pain during intercourse with a view to increasing adaptive coping, for example, by increasing self-efficacy and decreasing catastrophizing, as well as decreasing pain intensity; (4) improve the quality of sexual functioning, reduce sexual distress and increase sexual satisfaction; (5) consolidate skills.; Nightly applications of a 5% lidocaine ointment on the vulvar vestibule, at the entry of the vagina (50mg/g, Xylocaïne®, AstraZeneca, tube of 35g) for 12 weeks, as described by Zolnoun et al. (2003). In addition, the cream will be applied to a cotton ball kept on the vestibule via the participant's underwear overnight to ensure a continued 7 to 8-hour contact between the anesthetic and the vestibule. A pamphlet with figures detailing how to apply the cream will be given to participants, in addition to a calibrated measurement tool to ensure that all participants apply the same quantity every night.
Other intervention name(s): CBCT; Lidocaine; Xylocaine (R); Nightly lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulvodynia; Provoked vestibulodynia; Vulvar pain; Dyspareunia; Couples therapy; Lidocaine; Cognitive behavioral couple therapy; Cognitive behavioral therapy; Pain; Pain during sexual intercourse