Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia

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.

Conditions

• Vulvodynia
• Dyspareunia
• Vestibulodynia

Interventions

BEHAVIORAL

Cognitive Behavioral Couple Therapy

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.

OTHER

Topical Lidocaine

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.

Sponsors & Collaborators

• Université de Montréal

  lead OTHER

Principal Investigators

• Sophie Bergeron, PhD · Université de Montréal

• Natalie O Rosen, PhD · Dalhousie University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-06

Primary Completion

2018-03-19

Completion

2018-12-10

Countries

• Canada

Study Locations