(083) Baseline Characteristics of Participants in a Multicenter Randomized Clinical Trial of Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (Vestibulodynia: UPDATe)
Notice bibliographique
Résumé
Abstract Introduction Vestibulodynia (VBD) is a common cause of sexual pain that affects ~14 million women in the United States. Many different therapies are used on a trial-and-error basis which can delay effective care. Two distinct VBD subtypes may benefit from different types of treatment: 1) VBD peripheral (VBD-p) - pain localized to the vulvar vestibule and 2) VBD central (VBD-c) - VBD and >1 chronic overlapping pain condition(s) affecting remote body regions. Thus, we are evaluating the efficacy of peripheral, central, and combined treatments for VBD-p vs VBD-c. We will also evaluate cytokine and microRNA biomarkers to help determine pathophysiology and predict treatment response. Objective To describe the design and present baseline participant characteristics of our ongoing RCT for VBD. Methods This is a multi-site randomized, double-blind trial that will enroll participants to one of four parallel arms: 1) peripheral treatment with 5% lidocaine/0.5 mg/ml 0.02% estradiol compound cream and placebo pills, 2) central treatment with tricyclic antidepressant nortriptyline pills and placebo cream, 3) lidocaine/estrogen cream and nortriptyline pills, or 4) placebo cream and placebo pills. The treatment phase will last 16 weeks, with clinical outcome measures and biomarkers assessed at 4 time points (0, 8, 16, and 24 weeks). We will enroll 400 women 18-50 years who report tenderness at the vulvar vestibule and report >3/10 pain with tampon insertion on a numeric rating scale (NRS). Primary outcome is pain with tampon test. Secondary outcomes include self-reported pain on the McGill Pain Questionnaire, psychosocial measures, pressure pain thresholds (PPTs) measured at the vaginal vestibule, levator ani muscles, and remote body sites, and levels of cytokines and microRNAs in local vaginal and circulating blood samples using multiplex assays and RNA sequencing to determine the ability of these biomarkers to predict treatment response. Results So far 135 subjects have enrolled and 78 of these have completed the study. Enrollment remains open, with 27 subjects active and 30 subjects discontinued. Mean (range) age is 26.9 (18-48) years and body mass index is 23.7 (16-37). Self-disclosed racial identity of subjects is: White (67.4%), Asian (14.1%), Multiracial (9.6%), Black (8.9%), with 14.8% of subjects identifying as Hispanic or Latino. Of the enrolled subjects, 94/135 (69.6%) subjects are categorized VBD-c, and 41/135 (30.4%) are categorized VBD-p. Of those categorized as VBD-c, fibromyalgia syndrome (39.3%), endometriosis (34.1%), back pain (25.20%), irritable bowel syndrome (19.3%), chronic headaches (16.3%), temporomandibular disorder (11.1%), interstitial cystitis (10.4%) and chronic fatigue syndrome (1.5%) have been reported. At baseline visit, subjects report an average tampon test score of 4.2 (□ 2.11) and 93.3% of subjects report pain during vaginal intercourse. Conclusions We have launched a multicenter randomized trial to evaluate the efficacy of peripherally and centrally acting medications used for treating unique VBD subtypes based on distinct clinical and biological signatures. We hope to advance our knowledge of the pathophysiologic mechanisms underlying VBD-p and VBD-c, determine the efficacy of peripheral, central, and combined therapies in alleviating pain in women with VBD-p and VBD-c, and identify biomarkers that predict treatment response. Disclosure No
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,007 | 0,009 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».