Plain English Summary
Background and study aims
Vulvodynia is a persistent, unexplained pain in the vulva (skin surrounding the vagina) or where the vulva meets the vagina (vestibule). This pain can either be constant with no definable trigger (unprovoked) or triggered when the vulva or vestibule is touched (provoked), such as during sexual intercourse. The exact cause of provoked vvulvodynia (PVD) is not known which makes it very difficult to treat. Many remedies have been suggested, including medications, exercises to help relax and strengthen vaginal muscles so they are not as sensitive to pain (desensitisation) and even taking therapies such as cognitive behavioural therapy (CBT). The aim of this study is to find out whether a treatment involving special exercises and CBT can help women to regain their interest in sex and sexual satisfaction as well as helping to relieve pain during sex.
Who can participate?
Women who have been experiencing PVD for at least six months.
What does the study involve?
Participants are given a ten week programme consisting of weekly CBT sessions, and specially designed exercises which work on relaxing the vaginal muscles and desensitising them to pain. At the start of the study and the end of the ten week period, women complete questionnaires in order to find out whether the programme is able to make a difference to the quality of their sex lives.
What are the possible benefits and risks of participating?
There is currently very little evidence for how to best treat women having sexual difficulties. Women involved in this trial could potentially benefit from the treatments given. There are no risks of participating in the study.
Where is the study run from?
Helsingborg Hospital (Sweden)
When is the study starting and how long is it expected to run for?
January 2012 to August 2014
Who is funding the study?
1. Stig & Ragna Gorthon Foundation (Sweden)
2. Thelma Zoégas Foundation (Sweden)
Who is the main contact?
Dr Suzanne Lindström
suzanne.lindstrom@telia.com
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Suzanne Lindström
ORCID ID
Contact details
Sexology Dept.
Najaden Midwifery Clinic
Drottninggatan 7
Helsingborg
25221
Sweden
+46706248630 (+46730210630)
suzanne.lindstrom@telia.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Treatment of provoked vulvodynia in a Swedish cohort using desensitization exercises and cognitive behavioral therapy
Acronym
Study hypothesis
Treatment of provoked vulvodynia by desensitization exercises and cognitive behavioral therapy (CBT) will result in a 5% increase in scores on the McCoy Female Sexuality Questionnaire.
Ethics approval
Regional Ethics Committee in Lund, Sweden, ref: 2012/116
Study design
Single-centre case series study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Vulvodynia
Intervention
During a ten-week period the women recruited to the study attended ten treatment sessions. These sessions focused on discussions about the woman’s intimate relationship, on improving the individual’s knowledge of her bodily functions, helping her to train her sexual responses and learning to feel sexual pleasure on the same terms as her partner so that both could experience pleasure and no one’s needs dominated. Each session took approximately 60 minutes. Discussions about the individual woman’s life situation, about couple relationships and about how sexual pain may reflect relationship problems were an integral part of the CBT. During the ten-week period the woman had contact with the same therapist. The therapist herself received regular supervision sessions with a cognitive psychotherapist / psychiatrist. All treatments were carried out by the same therapist and were individualised which meant that some women made quicker progress than others but all were offered the full ten sessions.
The sessions included information and education about dyspareunia, PVD and vaginismus and how pain impacts desire, sexual response and arousal. A presentation was given of the female genital anatomy, using a detailed plastic model and photographs of the vulva and vagina. A gynaecological examination was carried out sensitively and carefully and the woman’s individual pain problems were confirmed. With the aid of a hand mirror the woman showed where her pain was located and explained her sensations of pain. The woman was asked to avoid soap for intimate hygiene and instead to use neutral oil. If the woman lived in a relationship with a partner she was instructed that penile penetration should be avoided until there was improvement in her experience of pain. Goals for treatment were negotiated between the patient and therapist and it was important also to formulate interim goals, such as being able to carry out a vaginal examination or penile penetration without pain or with reduced pain.
The woman was given information about CBT which required some homework in the form of training to re-direct negative thought-pathways. Many women have repressed their thoughts about sexual activity and part of their homework was also to allow these thoughts freedom and to give thought to what they wanted and needed sexually. An important example of this kind of re-direction is in how the woman might express her pain and problems for her partner.
Exercises aimed to desensitize the pain memory response were gradually initiated and included training to feel tension and relaxation in the muscles of the pelvic floor and vagina by insertion into the vagina of one or two of the woman’s own fingers and progressively the partner’s fingers. Rather than avoidance of touch to the painful area the woman was instructed in regular, daily self-examination using a hand mirror, to touch and massage the area with oil and to use acupressure. Use of tampons during menstruation was encouraged. When the woman felt that she had mastered the exercises and if she was living together with a partner she was asked to gradually introduce the partner to partake in the exercises. Results of the homework were discussed each time the woman and therapist met.
At each new session an agenda was formulated by the woman and therapist together and was always initiated with the question ”How have things been since our last meeting”? The woman was also encouraged to give a synopsis and critique of the previous session. At each session a vaginal examination was carried out with the woman partaking actively by means of a hand mirror. A dialogue was upheld about how the woman’s sex life and relationship was developing. Sex resources such as vibrators, dildos and lubricating gels were introduced progressively if these were acceptable. A discussion ensued about how the homework had progressed and new homework was negotiated. Finally the woman was asked to make a summary of the day’s session and feed-back was given by the therapist.
Intervention type
Mixed
Phase
Drug names
Primary outcome measures
Changes in the total MFSQ scores and in individual items on the MFSQ before and directly after treatment completion, using statistical measures.
Secondary outcome measures
Statistical comparison of the answers to the separate questions on the MFSQ before treatment and six months after treatment, using the Wilcoxon signed-rank test.
Overall trial start date
01/10/2011
Overall trial end date
27/02/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women aged 18 years or over
2. A diagnosis of provoked vulvodynia (PVD) based on the patient’s self-report of pain at the entrance to the vagina during any attempt at penetration and confirmed by the cotton-swab test
3. Experiencing symptoms for at least six months and had:
3.1. Severe pain upon vestibular touch or attempted vaginal entry
3.2. Tenderness to pressure localized within the vulvar-vestibule
3.3. Vestibular erythema of various degrees.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
1. Current infection or diagnosed dermatological disease of the genital area
2. Diagnosis of acute psychiatric illness or any other major medical problems requiring medical treatment
Recruitment start date
01/06/2012
Recruitment end date
31/08/2014
Locations
Countries of recruitment
Sweden
Trial participating centre
Helsingborg Hospital
Södra Vallgatan 5
Helsingborg
25187
Sweden
Sponsor information
Organisation
Lund University
Sponsor details
Box 117
Lund
22100
Sweden
+462220000
lu@lu.se
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Stig & Ragna Gorthon Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Thelma Zoégas Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish in the open access journal BMC: Women's Health
Intention to publish date
30/11/2015
Participant level data
Other
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26603697