A conceptual model for managing sexual pain with somatocognitive therapy in women with provoked vestibulodynia and implications for physiotherapy practice.

Somatocognitive therapy is a multimodal physiotherapy treatment developed in the early 2000s to alleviate the burden of chronic pelvic pain. In recent years, somatocognitive therapy has been further developed to treat women with provoked vestibulodynia. This prevalent gynecological pain condition is a subgroup of chronic pelvic pain and the most common form of vulvodynia. Provoked vestibulodynia is a neglected multifactorial pain condition of unknown cause, adversely affecting women's sexual life, relation to their partners and their psychological health. Pain is located at the vulvar vestibule and is provoked by touch or pressure such as sexual intercourse. In the management of sexual pain, somatocognitive therapy combines bodily exploration, pain education, cognitive coping strategies and structured homework to improve sexual function and reduce pain. To support these processes, developing a sound therapeutic alliance with the patient is essential. The aim of this article is to provide a conceptual model for managing provoked vestibulodynia with somatocognitive therapy, including a theoretical rational for this treatment. We base our conceptual model on the biopsychosocial model, i.e., considering the complex interplay of biomedical, emotional/cognitive, psychosexual and interpersonal factors in provoked vestibulodynia management. In addition, implications for practice and a detailed description of somatocognitive therapy for provoked vestibulodynia will be provided, to allow replication in clinical practice and in clinical trials.

Feasibility and acceptability of somatocognitive therapy in the management of women with provoked localized vestibulodynia-ProLoVe feasibility study.

BACKGROUND: Provoked vestibulodynia (PVD) is a prevalent chronic pain condition especially among young women. Pain is localized to the vulvar vestibule and is provoked by touch or pressure, such as penetrative intercourse. PVD can have profound consequences, adversely affecting a woman's sexual life, relation to her partner, and her psychological health. There is an urgent need for well-designed randomized clinical trials (RCTs) to identify the most effective interventions for this neglected women's health condition. AIMS: The primary aim of this study is to assess the feasibility of undertaking a full-scale RCT of somatocognitive therapy (SCT), a multimodal physiotherapy intervention, for women with PVD. The secondary aim is to evaluate the implementation and acceptability of SCT and its potential treatment effectiveness in PVD. In the full-scale RCT, SCT will be compared to standard PVD treatment. METHODS: A multimethod feasibility study with a single-arm before-after trial and qualitative interviews. Ten women with PVD, aged 18-33 were recruited from the Vulva Clinic at Oslo University Hospital. The intervention took place at Oslo Metropolitan University. Participants were assessed at baseline, post-treatment, and the 8-month follow-up with the tampon test and self-report questionnaires. The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools, and follow-up rate. The participants' experiences with the primary outcome and the intervention were explored with semi-structured interviews. RESULTS: Ten out of 18 eligible patients were recruited over 11 weeks. None were lost to follow-up. Adherence to self-report questionnaires was excellent. Adherence to tampon tests and to the reporting of treatments was good, whereas adherence to the 14-day diary was poor. No adverse events were reported. The tampon test was suboptimal as a primary outcome. SCT was found to be an acceptable treatment, based on Global Perceived Effect scores and the participants' experiences. CONCLUSION: The findings suggest that it is feasible to deliver a full-scale RCT of the SCT intervention for women with PVD. Some changes are suggested to optimize the protocol, such as increasing recruitment sites, change of primary outcome measures, and adding a booster session. TRIAL REGISTRATION: ClinicalTrials.gov NCT04208204 . Retrospectively registered on December 23, 2019.

Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial.

BACKGROUND: Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal erosions and scarring, often resulting in poor sexual health and reduced quality of life. Treatment options are limited and often with little effect. Apremilast, a phosphodiesterase 4-inhibitor, has been shown to have a positive effect on psoriasis and other inflammatory skin diseases. We aim to investigate the effect and safety of peroral apremilast in women with GELP in a randomised placebo-controlled double-blinded clinical trial. METHODS: We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a specialised vulva clinic in Oslo, Norway. The patients will be randomised 1:1 to either apremilast 30 mg BID (with an initial dose titration on days 1-6) or a placebo for 24 weeks. The concomitant use of topical corticosteroids will be allowed. The primary end point will be the mean GELP score, a clinical scoring system, at week 24 in the apremilast-treated patients versus the placebo-treated patients. The secondary end points will include the mean GELP score improvement from weeks 0 to 24, patient-reported use of topical steroids, the pain score on a visual analogue scale and the number of patients with GELP score improvements at weeks 16 and 24. The Physician Global Assessment , Patient Global Assessment and selected quality of life and sexual function assessments will be recorded at weeks 0, 16 and 24. The exploratory endpoints include description of immunohistochemical changes before and after apremilast therapy, assessed in vulvar or vaginal biopsies at weeks 0 and 24. Regular follow-ups for possible adverse events will be conducted. DISCUSSION: The study design is based on experience from studies on apremilast in other inflammatory skin diseases using equivalent apremilast doses for approved indications. The trial may provide evidence for the use of apremilast in women with this burdensome genital dermatosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT0365666 . Registered on 4 September 2018.

The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study.

BACKGROUND: Provoked vestibulodynia (PVD) is characterized by severe pain, often induced by penetrative sex. This may lead to women abstaining from sexual intercourse, hence the recording of pain intensity levels in PVD research is often challenging. The standardized tampon test was designed as an alternative outcome measure to sexual intercourse pain and has frequently been used in clinical studies. AIM: The aim of this mixed methods study is to evaluate the tampon test as a primary outcome measure for an upcoming randomized clinical trial for women with PVD. METHODS: An explanatory sequential design was applied, integrating quantitative and qualitative methods. In phase one, pain intensity levels were evaluated with the tampon test amongst 10 women, aged 18-33, with PVD. The test was repeated on day 1, 7 and 14. Pain intensity was rated on the Numerical Rating Scale (NRS), (0-10), 10 being worst possible pain. In phase two, the participants' experiences with the test were explored with semi-structured interviews using a descriptive and inductive qualitative design. All participants were recruited from the Vulva Clinic, Oslo University Hospital, Norway. OUTCOMES: The tampon test data and interviews were brought together to see how the interviews could refine and help to explain the quantitative findings. RESULTS: The tampon test data demonstrated large intra- and inter-individual variability. Median tampon pain intensity was 4.5 (min=1.7; max=10; Q1=2.5; Q3=6). Many experienced the test as an inadequate representation of pain during intercourse as it was less painful, different in nature and conducted in an entirely different context. Four participants had a mean score of four or lower on the NRS, whilst concurrently reporting high levels of pain during sexual intercourse. CLINICAL IMPLICATIONS: The findings indicate that the tampon test may underestimate severity of pain among some women with PVD. Participants with low pain scores would be excluded from studies where the tampon test is part of the trial eligibility criteria, even though severe pain was experienced during sexual intercourse. Large intra-individual variability in pain scores also reduces the test's ability to register clinical meaningful changes and hence necessitates repeated measurements per assessment time point. CONCLUSION: Although the tampon test has many advantages, this study indicates several potential problems with the application of the test as a primary outcome measure in PVD. In our opinion the test is most useful as a secondary outcome, preferably undertaken repeatedly in order to increase precision of the pain estimation. Kaarbø MB, Danielsen KG, Haugstad GK, et al. The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study. J Sex Med 2021;18:1083-1091.

Biodistribution of protoporphyrin IX in female genital erosive lichen planus after topical application of hexaminolevulinate.

Genital erosive lichen planus (GELP) is a chronic inflammatory disease, in women characterized by painful vulvar and vaginal erosions. To prepare for a clinical trial on photodynamic treatment (PDT), we applied hexyl 5-aminolevulinate hydrochloride (HAL) in clinically normal and affected mucosa in 12 women with GELP using two different doses (6.25 or 50mg/ml). Biopsies were taken after 30 min and 3h. The biodistribution of HAL, measured as photoactive protoporphyrin IX (PpIX), was studied using non-invasive superficial fluorescence measurements and microscopic fluorescence photometry. More PpIX was detected after application of 12.5mg HAL than after 100mg, with large inter-individual variations. PpIX levels after 3h were overall higher than after 30 min. PpIX fluorescence was not detected in skin distant to the genital area. In conclusion, 6.25mg/ml HAL applied for 3h seems adequate for HAL absorption and conversion to PpIX in submucosal inflammatory and epithelial cells and can be used in a PDT trial of GELP.

Vaginal involvement in genital erosive lichen planus.

A specialized Vulva Clinic with dedicated gynecologists and dermatologists was established in Oslo, Norway, in 2003. Fifty-eight women referred to the clinic in 2003-2009 were diagnosed with genital erosive lichen planus. All patients filled out a questionnaire. Gynecological examination, including vaginal inspection, was performed, if necessary in general anesthesia. Median age at symptom start was 51 years (range 17-78 years) with 15 women (26%) being younger than 40 years old. Sexual abstinence was reported by 36 women and dyspareunia by another 10. On examination, vaginal involvement was seen in 49 women, including vaginal synechiae in 29 and total obliteration of the vagina in 9. Of 56 women treated with topical corticosteroids for at least three months, two had complete response and 36 partial responses. Similarly, of 22 women treated with tacrolimus, three had complete and six partial response. We conclude that vaginal involvement is more common in genital erosive lichen planus than previously reported.