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

NACompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

March 6, 2014

Primary Completion Date

March 19, 2018

Study Completion Date

December 10, 2018

Conditions
VulvodyniaDyspareuniaVestibulodynia
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.

Trial Locations (2)

B3H 4R2

Dalhousie University, Halifax

H2V 2S9

University of Montreal, Montreal

All Listed Sponsors
lead

Université de Montréal

OTHER

NCT01935063 - Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia | Biotech Hunter | Biotech Hunter