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

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

doi:10.1016/j.jsxm.2021.03.010

Cited by 2 publications

(6 citation statements)

References 26 publications

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“…Evaluation of the tampon test is reported in a separate paper [ 46 ]. We concluded that the test may be suboptimal as a primary outcome measure in PVD research.…”

Section: Resultsmentioning

confidence: 99%

“…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. Several women also reported in the interviews that they experienced the test as an inadequate measure of their problem [ 46 ].…”

Section: Resultsmentioning

confidence: 99%

“…The tampon test was therefore chosen as a primary outcome measure as it was specifically designed to address this challenge [ 26 ]. Based on the tampon test data and the participants’ experiences with the test and input from a user representative, we concluded in a separate paper [ 46 ] that the tampon test is suboptimal as a primary outcome measure in PVD research. Therefore, in the upcoming RCT, the primary outcome measure will be the Female Sexual Function Index (FSFI), while the tampon test will be applied as a secondary outcome.…”

Section: Discussionmentioning

confidence: 99%

“…Adherence was defined as the number of participants who fully completed the battery of self-reported questionnaires, the 14-day diary, the number of performed tampon tests, and biweekly forms about the received treatment, within a time frame of 8 months. Evaluation of the utility value of the tampon test as a primary outcome measure based on tampon test data and the participants’ experiences with the tampon test (reported in separate mixed methods study [ 46 ].) Reporting of adverse events .…”

Section: Methodsmentioning

confidence: 99%

“…Evaluation of the utility value of the tampon test as a primary outcome measure based on tampon test data and the participants’ experiences with the tampon test (reported in separate mixed methods study [ 46 ].)…”

Section: Methodsmentioning

confidence: 99%

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

Kaarbø

Danielsen

Haugstad

et al. 2022

Pilot Feasibility Stud

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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.govNCT04208204. Retrospectively registered on December 23, 2019.

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“…Evaluation of the tampon test is reported in a separate paper [ 46 ]. We concluded that the test may be suboptimal as a primary outcome measure in PVD research.…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 3 more Smart Citations

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

Kaarbø

Danielsen

Haugstad

et al. 2022

Pilot Feasibility Stud

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Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe)

et al. 2022

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Background Limited data are available to establish evidence-based management protocols for vestibulodynia (VBD), a chronic vulvar pain condition that affects approximately 14 million women in the U.S. For the purposes of the study, our group subdivided VBD subtypes that may benefit from different types of treatment: 1) VBD peripheral (VBD-p), characterized by pain localized to the vulvar vestibule and 2) VBD central (VBD-c), characterized by VBD alongside one or more other chronic overlapping pain conditions (e.g. irritable bowel syndrome, temporomandibular disorder, and fibromyalgia syndrome) that affect remote body regions. Here, we describe the rationale and design of an NIH-funded multicenter clinical trial comparing the effectiveness of topical and/or systemic medication for alleviating pain and normalizing pain- relevant biomarkers among women with VBD-p and VBD-c. Methods Participants will be randomly assigned to one of four parallel arms: peripheral treatment with 5% lidocaine + 0.5 mg/ml 0.02% oestradiol compound cream + oral placebo pill, 2) central treatment with the tricyclic antidepressant nortriptyline + placebo cream, 3) combined peripheral cream and central pill treatments, or 4) placebo cream and placebo pill. The treatment phase will last 16 weeks, with outcome measures and biomarkers assessed at 4 time points (0, 8, 16, and 24 weeks). First, we will compare the efficacy of treatments in alleviating pain using standardized tampon insertion with a numeric rating scale and self-reported pain on the short form McGill Pain Questionnaire. Next, we will compare the efficacy of treatments in improving perceived physical, mental, and sexual health using standardized questionnaires. Finally, we will measure cytokines and microRNAs in local vaginal and circulating blood samples using multiplex assays and RNA sequencing, and determine the ability of these biomarkers to predict treatment response. Conclusion This is the first multicenter randomized controlled trial to evaluate the efficacy of peripherally and centrally acting medications currently used in clinical practice for treating unique VBD subtypes based on distinct clinical and biological signatures. Administrative information Vestibulodynia UPDATe is a multi-centre, two-by-two factorial designed randomized, double-blind, placebo-controlled trial registered at clinical trials.gov (NCT03844412). This work is supported by the R01 HD096331 awarded to Drs. Nackley, Rapkin, Geller and Carey by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Key messages Peripheral lidocaine and oestradiol and centrally-targeted nortriptyline medications are used for the treatment of pain in women with VBD, but there is a lack of data from well-powered RCTs. This two-by-two factorial RCT will test the efficacy of these medications in VBD subtypes cha...

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

Cited by 2 publications

References 26 publications

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

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

Rationale and design of a multicenter randomized clinical trial of vestibulodynia: understanding pathophysiology and determining appropriate treatments (vestibulodynia: UPDATe)

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