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  • Writer's pictureMUSK Health

Published paper: The ProLoVe Feasibility Study

New paper from the ProLoVe-project recently got published in the journal 'Pilot and Feasibility Studies'. Here follows a brief summary of the article:

There is an urgent need for well-designed randomized clinical trials (RCTs) to identify the most effective treatments for provoked vestibulodynia (PVD), a prevalent and persistent vulvar pain condition. Somatocognitive therapy (SCT) is a multimodal physiotherapy treatment which has demonstrated promising results in PVD. Before commencing a RCT it is recommended to run a feasibility study.

In this multimethod feasibility study, women with PVD were recruited from the Vulva Clinic, Oslo University Hospital and treated with SCT. Tampon tests and self-report questionnaires were undertaken at baseline, post-treatment and 8 months. The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools and follow-up rate. Experiences with the tampon test and SCT were explored with semi-structured interviews, towards the end of treatment and one year later.

Ten out of 18 eligible patients were recruited, with none lost to follow-up. Adherence to assessment tools ranged from excellent (self-report questionnaires), good (tampon tests and reporting of treatments) to poor (14-day diary). No adverse events were reported. The tampon test was a suboptimal primary outcome. SCT was found to be an acceptable treatment based on Global Perceived Effect Scores and the participants experiences.

The findings suggest that it is feasible to deliver a full-scale RCT of SCT for women with PVD. Some changes are suggested, such as increasing recruitment sites, change of primary outcome measure to Female Sexual Function Index and adding a booster session.

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

Published: 23rd of March 2022 in Pilot and Feasibility Studies

Read more about the ProLoVe project here.


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