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Effectiveness of Cognitive Behavioural Therapy and Physical Therapy for Provoked Vestibulodynia

A Randomized Comparison of Individual Cognitive-behavioural Therapy and Pelvic Floor Rehabilitation in the Treatment of Provoked Vestibulodynia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02494934
Enrollment
20
Registered
2015-07-10
Start date
2009-09-30
Completion date
2012-04-30
Last updated
2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar Vestibulitis

Brief summary

The purpose of the study was to compare the effectiveness of cognitive behavioural therapy (CBT) and physical therapy (PT) on pain and psychosexual outcomes in women with provoked vestibulodynia (PVD).

Detailed description

Provoked vestibulodynia (PVD) is the most common condition leading to painful intercourse and is currently best understood within a biopsychosocial framework. Although the usefulness of non-medical treatment options for vulvar pain is recognized by many, there is limited research investigating the effectiveness of these treatments using a biopsychosocial approach to outcome measurement. Furthermore, there is little evidence to support the mechanisms by which these treatments lead to pain reduction. This study aimed to address these gaps by investigating two non-medical treatment options: individual cognitive-behavioural therapy (CBT) and physical therapy (PT).

Interventions

The CBT program was adapted from a previously used group CBT program and included the following procedures: (1) education about PVD; (2) collaborative re-conceptualization of PVD as a multi-factorial pain condition; (3) desensitization exercises; (4) diaphragmatic breathing and other relaxation techniques; (5) discussion about and techniques for increasing sexual desire and arousal; (6) sexual communication skills training; (7) instructions on carrying out PFM exercises; (8) instructions on the use of silicone vaginal dilators to do progressive vaginal penetration activities at home; and (9) informal and formal cognitive restructuring techniques and the use of coping self-statements.

BEHAVIORALphysical therapy

The PT treatment protocol included the following procedures: (1) education about PVD; (2) targeted PFM exercises focused on contraction and relaxation including in-session practice and feedback; (3) manual techniques; (4) surface electromyographic biofeedback (sEMG); (5) progressive vaginal penetration activities through the use of four silicone vaginal dilators of varied diameter; (6) stretches of the hip muscles; (7) deep breathing and global body relaxation exercises; and (8) additional methods of managing pain and counseling about different sexual positions.

Sponsors

Queen's University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* fluent in English * vulvar pain with attempted vaginal penetration for at least 6 months * pain limited to vulvar vestibule during cotton swab test

Exclusion criteria

* other serious medical, psychiatric, or other pain conditions * generalized vulvodynia and/or significant vaginismus (i.e., not able to have at least one finger inserted vaginally) * current pregnancy, breastfeeding, or being less than 6 months postpartum * unwillingness to abstain from other treatments for their PVD pain during the course of the study

Design outcomes

Primary

MeasureTime frameDescription
change from baseline in pain with sexual intercourse at 12 weeksBaseline, 12 weeksmeasured on an 11-point numerical rating scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026