*THIS STUDY IS NOW CLOSED FOR RECRUITMENT. WE ARE GRATEFUL TO ALL THE PARTICIPANTS FOR THEIR TIME AND ENERGY. WE WILL POST A SUMMARY OF OUR RESULTS AS SOON AS WE ARE ABLE*
The Couples and Sexual Health Laboratory at Dalhousie University is collaborating with the Women’s Sexual Health Laboratory at the University of Montreal to conduct a treatment study for women with Provoked Vestibulodynia (PVD; recurrent vulvovaginal pain).
This PVD treatment study is a randomized clinical trial that will compare and evaluate the potential effectiveness of two treatments for women with PVD. These treatments are:
- 12-week standard medical treatment (local anesthetic lidocaine ointment)
- 12-week Cognitive-Behavioural Couple Therapy (CBCT)
Eligible women and their romantic partners will be randomly assigned to receive one of these two treatments; in other words, couples must be willing to accept either treatment as they cannot choose which one they will receive.
We aim to evaluate the potential effectiveness of a Cognitive-Behavioral Couple Therapy (CBCT) for couples where the woman experiences PVD by comparing it with a standard medical treatment (local anesthetic lidocaine). From this study, we hope to learn whether one treatment is more effective than the other, or whether they are both effective treatments. We also hope to learn whether the interventions differ in their ability to treat some of the associated consequences of PVD that women and partners often experience, such as reductions in sexual satisfaction and sexual function.
Who can participate
- Women (or female-bodied individuals) aged 18 to 45 years, experiencing vulvo-vaginal pain, and their partners (aged 18 or older).
- Women with vulvo-vaginal pain must receive a diagnosis of Provoked Vestibulodynia (recurrent vulvar pain) from our study gynecologist.
- Couples must be cohabitating and/or been a couple for at least 3 months. If not cohabitating, the couple must have at least 4 in-person contacts per week.
- Have been sexually active as a couple as least once per month in the last 3 months (includes any of the following: vaginal penetration, oral, or manual stimulation; but must include some attempted vaginal penetration over this period).
- Not be receiving treatment for PVD or couple therapy during the course of this study.
- Not have an allergy to Lidocaine.
- Have daily internet access
- Have the ability to read, write, and speak English fluently.
What we will ask you to do
First, we ask that the partner with pain undergo a medical appointment and gynecological examination with our study gynecologist to receive a PVD diagnosis.
Couples will then be randomized to one of two clinical interventions:
- Lidocaine is an anesthetic cream applied to the skin that will make the area feel temporarily numb. Lidocaine is often prescribed to women diagnosed with PVD because it is believed that it can reduce the sensitivity of the nerve receptors in the vulvar area (i.e., the nerves that respond to touch and trigger the pain sensation.)
- Cognitive behavioural couple therapy (CBCT) is a couple’s intervention where you and your partner will see a therapist to talk about the pain and the impact it is having on you, your partner, your sex lives, and your relationship. You and your partner will also complete several in-session and home-based exercises where you will both learn pain-management, communication, and sexual techniques to help build your skills for managing the impact of PVD together.
We ask that you undergo the treatment to which you are assigned for a period of 12-weeks. We will send you brief online questionnaires every few weeks throughout the treatment.
You will be asked to attend 3 additional appointments with research personnel at the Couples and Sexual Health Laboratory, Dalhousie University: one before the study begins, one after the treatment, and another 6 months after treatment ends. During these appointments we ask that you complete an interview and questionnaires.
What are the benefits to participating in this study?
- Your participation may provide important information that will help us to improve treatments for PVD.
- We will provide compensation for the time it takes to complete the questionnaires in our laboratory, and reimburse you for parking expenses.
- The treatment to which you are randomly assigned is free of charge.
- Your confidentiality and anonymity are assured.
For more information, contact us using the form below.
This study is directed by Dr. Natalie O. Rosen, Department of Psychology and Neuroscience, Dalhousie University & IWK Health Centre, Halifax Nova Scotia, in collaboration with the Women’s Sexual Health Laboratory at the University of Montreal. The research is funded by an operating grant from the Canadian Institutes of Health Research (CIHR).