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

Mette Bøymo Kaarbø, Kristine Grimen Danielsen, Gro Killi Haugstad, Anne Lise Ording Helgesen, Slawomir Wojniusz, Mette Bøymo Kaarbø, Kristine Grimen Danielsen, Gro Killi Haugstad, Anne Lise Ording Helgesen, Slawomir Wojniusz

Abstract

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.

Keywords: Feasibility study; Provoked vestibulodynia; Somatocognitive therapy; Vestibulitis; Vulvodynia.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT 2010 flow diagram. Design and flow of participants through the study

References

    1. Harlow BL, Kunitz CG, Nguyen RH, Rydell SA, Turner RM, MacLehose RF. Prevalence of symptoms consistent with a diagnosis of vulvodynia: population-based estimates from 2 geographic regions. Am J Obstet Gynecol. 2014;210(1):40.e1–40.e8.
    1. Gomez I, Coronado PJ, Martin CM, Alonso R, Guisasola-Campa FJ. Study on the prevalence and factors associated to vulvodynia in Spain. Eur J Obstet Gynecol Reprod Biol. 2019;240:121–124.
    1. Vieira-Baptista P, Lima-Silva J, Cavaco-Gomes J, Beires J. Prevalence of vulvodynia and risk factors for the condition in Portugal. Int J Gynecol Obstet. 2014;127(3):283–287.
    1. Reed BD, Legocki LJ, Plegue MA, Sen A, Haefner HK, Harlow SD. Factors associated with vulvodynia incidence. Obstet Gynecol. 2014;123(2 Pt 1):225–231.
    1. Clare CA, Yeh J. Vulvodynia in adolescence: childhood vulvar pain syndromes. J Pediatr Adolesc Gynecol. 2011;24(3):110–115.
    1. Bergeron S, Reed BD, Wesselmann U, Bohm-Starke N. Vulvodynia. Nat Rev Dis Primers. 2020;6(1):36.
    1. Sadownik LA. Etiology, diagnosis, and clinical management of vulvodynia. Int J Women's Health. 2014;6:437–449.
    1. Basson R, Driscoll M, Correia S. When sex is always painful: provoked vestibulodynia. BCMJ. 2016;58(2):77–81.
    1. Desrochers G, Bergeron S, Khalife S, Dupuis MJ, Jodoin M. Fear avoidance and self-efficacy in relation to pain and sexual impairment in women with provoked vestibulodynia. Clin J Pain. 2009;25(6):520–527.
    1. Xie Y, Shi L, Xiong X, Wu E, Veasley C, Dade C. Economic burden and quality of life of vulvodynia in the United States. Curr Med Res Opin. 2012;28(4):601–608.
    1. Benoit-Piau J, Bergeron S, Brassard A, Dumoulin C, Khalife S, Waddell G, et al. Fear-avoidance and pelvic floor muscle function are associated with pain intensity in women with vulvodynia. Clin J Pain. 2018;34(9):804–810.
    1. Dargie E, Gilron I, Pukall C. Provoked vestibulodynia: a comparative examination of mental health, sleep, sexual functioning, and relationship adjustment. Clin J Pain. 2017;33(10):870–876.
    1. Aikens JE, Reed BD, Gorenflo DW, Haefner HK. Depressive symptoms among women with vulvar dysesthesia. Am J Obstet Gynecol. 2003;189(2):462–466.
    1. Nylanderlundqvist E, Bergdahl J. Vulvar vestibulitis: evidence of depression and state anxiety in patients and partners. Acta Derm Venereol. 2003;83(5):369–373.
    1. Shallcross R, Dickson JM, Nunns D, Mackenzie C, Kiemle G. Women’s subjective experiences of living with vulvodynia: a systematic review and meta-ethnography. Arch Sex Behav. 2018;47(3):577–595.
    1. Morin M, Carroll MS, Bergeron S. Systematic review of the effectiveness of physical therapy modalities in women with provoked vestibulodynia. Sex Med Rev. 2017;5(3):295–322.
    1. Polpeta NC, Giraldo PC, Teatin Juliato CR, Gomes Do Amaral RL, Moreno Linhares I, Romero Leal Passos M. Clinical and therapeutic aspects of vulvodynia: the importance of physical therapy. Minerva Ginecol. 2012;64(5):437–445.
    1. Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalife S, Waddell G, et al. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a prospective, multicentre, randomized trial. Am J Obstet Gynecol. 2021;224(2):189.e1–189.e12.
    1. Haugstad GK, Haugstad TS, Kirste UM, Leganger S, Wojniusz S, Klemmetsen I, et al. Posture, movement patterns, and body awareness in women with chronic pelvic pain. J Psychosom Res. 2006;61(5):637–644.
    1. Haugstad GK, Haugstad TS, Kirste UM, Leganger S, Klemmetsen I, Malt UF. Mensendieck somatocognitive therapy as treatment approach to chronic pelvic pain: results of a randomized controlled intervention study. Am J Obstet Gynecol. 2006;194(5):1303–1310.
    1. Haugstad GK, Haugstad TS, Kirste UM, Leganger S, Wojniusz S, Klemmetsen I, et al. Continuing improvement of chronic pelvic pain in women after short-term Mensendieck somatocognitive therapy: results of a 1-year follow-up study. Am J Obstet Gynecol. 2008;199(6):615.
    1. Haugstad GK, Wojniusz S, Kirschner R, Kirste U, Lilleheie I, Haugstad TS. Somatocognitive therapy of women with provoked vulvodynia: a pilot study. Scand J Pain. 2019;19(4):725–732.
    1. Groven KS, Raheim M, Hakonsen E, Haugstad GK. "Will I ever be a true woman?" an exploration of the experiences of women with vestibulodynia. Health Care Women Int. 2016;37(8):818–835.
    1. Fougner M, Haugstad GK. Treating gynaecological pain: the experiences of bachelor students in physiotherapy performing somatocognitive therapy. Physiother Theory Pract. 2015;31(5):318–326.
    1. Chisari C, Monajemi MB, Scott W, Moss-Morris R, McCracken LM. Psychosocial factors associated with pain and sexual function in women with vulvodynia: a systematic review. Eur J Pain. 2021;25(1):39–50.
    1. Foster DC, Kotok MB, Huang LS, Watts A, Oakes D, Howard FM, et al. The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness. Obstet Gynecol. 2009;113(4):825–832.
    1. Stockdale CK, Lawson HW. 2013 vulvodynia guideline update. J Low Genit Tract Dis. 2014;18:93–100.
    1. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239.
    1. Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, et al. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191–208.
    1. Fernandes L, Storheim K, Lochting I, Grotle M. Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskelet Disord. 2012;13:111.
    1. Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins symptom checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974;19(1):1–15.
    1. Strand BH, Dalgard OS, Tambs K, Rognerud M. Measuring the mental health status of the Norwegian population: a comparison of the instruments SCL-25, SCL-10, SCL-5 and MHI-5 (SF-36) Nord J Psychiatry. 2003;57(2):113–118.
    1. Rost S, Van Ryckeghem DML, Koval P, Sütterlin S, Vögele C, Crombez G. Affective instability in patients with chronic pain: a diary approach. Pain. 2016;157(8):1783–1790.
    1. Pukall CF, Bergeron S, Brown C, Bachmann G, Wesselmann U, Group VCR Recommendations for self-report outcome measures in vulvodynia clinical trials. Clin J Pain. 2017;33(8):756–765.
    1. De Andres J, Sanchis-Lopez N, Asensio-Samper JM, Fabregat-Cid G, Dolz VM. Peripheral subcutaneous vulvar stimulation in the management of severe and refractory vulvodynia. Obstet Gynecol. 2013;121:495–498.
    1. Phillips NA, Brown C, Foster D, Bachour C, Rawlinson L, Wan J, et al. Presenting symptoms among premenopausal and postmenopausal women with vulvodynia. Menopause. 2015;22(12):1296–1300.
    1. Brown C, Bachmann GA, Wan J, Foster D. Pain rating in women with provoked vestibulodynia: evaluating influence of race. J Women's Health. 2016;25(1):57–62.
    1. Brown CS, Bachmann GA, Wan J, Foster DC, Group GS Gabapentin for the treatment of vulvodynia: a randomized controlled trial. Obstet Gynecol. 2018;131(6):1000–1007.
    1. Foster DC, Kotok MB, Huang LS, Watts A, Oakes D, Howard FM, et al. Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial. Obstet Gynecol. 2010;116(3):583–593.
    1. Guillet AD, Cirino NH, Hart KD, Leclair CM. Mindfulness-based group cognitive behavior therapy for provoked localized vulvodynia: a randomized controlled trial. J Low Genit Tract Dis. 2019;23(2):170–175.
    1. Lev-Sagie A, Kopitman A, Brzezinski A. Low-level laser therapy for the treatment of provoked vestibulodynia-a randomized, placebo-controlled pilot trial. J Sex Med. 2017;14(11):1403–1411.
    1. Kvale S, Brinkman S. Det kvalitative forskningsintervju (interviews: learning the craft of research interviewing) 2. Oslo: Gyldendal Akademisk; 2009.
    1. Danielsen KG, Dahl-Michelsen T, Hakonsen E, Haugstad GK. Recovering from provoked vestibulodynia: experiences from encounters with somatocognitive therapy. Physiother Theory Pract. 2019;35:219–228.
    1. Haugstad GK, Wojniusz S, Kirste UM, Kirschner RS, Lilleheie I, Haugstad TS. Pain, psychological distress and motor pattern in women with provoked vestibulodynia (PVD) – symptom characteristics and therapy suggestions. Scand J Pain. 2018;18(2):221–7.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.
    1. Kaarbø MB, Danielsen KG, Haugstad GK, Helgesen ALO, Wojniusz S. The tampon test as a primary outcome measure in provoked vestibulodynia: a mixed methods study. J Sex Med. 2021;18(6):1083–1091.
    1. Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global perceived effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010;63(7):760–6.e1.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.
    1. Smith KB, Pukall CF, Chamberlain SM. Sexual and relationship satisfaction and vestibular pain sensitivity among women with provoked vestibulodynia. J Sex Med. 2013;10(8):2009–2023.
    1. Smith KB, Sadownik LA, Dargie E, Albert AYK, Brotto LA. Multidisciplinary treatment for provoked vestibulodynia. Clin J Pain. 2019;35(4):335–344.
    1. Rosen NO, Bergeron S, Pukall CF. Recommendations for the study of vulvar pain in women, part 1: review of assessment tools. J Sex Med. 2020;17(2):180–194.

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