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Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response.

ABSTRACT:

Introduction

Few randomized controlled trials (RCTs) have been conducted to establish evidence-based management protocols for provoked vestibulodynia (PVD), a chronic vulvar pain condition affecting approximately 14 million women in the U.S. We describe the rationale and design of an NIH funded multicenter clinical trial utilizing an extended release formulation of gabapentin (G-ER), an intervention that preliminary data suggest may be efficacious for this condition.

Objectives

1) to determine if pain from tampon insertion (primary outcome measure) is lower in PVD patients when treated with G-ER compared to when treated with placebo and 2) to determine if G-ER reduces vulvar mechanical hyperalgesia, vaginal muscle pain to palpation, the number and intensity of somatic tenderpoints, spontaneous and provoked pain to intradermal capsaicin with an accompanying increase in cardiac beat-to-beat variability and to identify mechanistically-based PVD subtypes. Additional outcomes include subject reported intercourse pain and summative 24-hour pain.

Methods

This 16-week, randomized, double-blind, placebo-controlled, crossover study will enroll 120 women 18 years and older who report tenderness localized to the vulvar vestibule, pain with tampon insertion, and, when sexually active, insertional dyspareunia. Electronically entered daily diaries will be used to determine if pain is lower in PVD subjects when treated with G-ER (up to 3000 mg/d) compared to when treated with placebo. Psychophysiological measures will be obtained at baseline and after 2 weeks at the maximum tolerated dose.

Conclusion

We will conduct the first multicenter RCT to confirm efficacy of an agent that is currently used in clinical practice for treating PVD.

SUBMITTER: Brown CS

PROVIDER: S-EPMC3779071 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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Publications

Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response.

Brown Candace S CS Foster David C DC Wan Jim Y JY Rawlinson Leslie A LA Bachmann Gloria A GA

Contemporary clinical trials 20130629 1

<h4>Introduction</h4>Few randomized controlled trials (RCTs) have been conducted to establish evidence-based management protocols for provoked vestibulodynia (PVD), a chronic vulvar pain condition affecting approximately 14 million women in the U.S. We describe the rationale and design of an NIH funded multicenter clinical trial utilizing an extended release formulation of gabapentin (G-ER), an intervention that preliminary data suggest may be efficacious for this condition.<h4>Objectives</h4>1) ...[more]

PMID: 23816491

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Project description:IntroductionPelvic pain and vulvar pain are common conditions in women. In this study, we sought to characterize the clinical picture of patients with concurrent pelvic pain and provoked vestibulodynia (PVD).AimTo analyze the association between sexual/clinical characteristics and a diagnosis of PVD among women with pelvic pain.MethodsCross-sectional analysis of a prospective registry at a tertiary referral center for pelvic pain and endometriosis, involving consecutive non-menopausal sexually active patients 18-49 years-old seen by a single gynecologist from January 2016-December 2017. The sample was divided into 2 groups: pelvic pain with PVD; and pelvic pain alone (without PVD).Main outcome measuresSuperficial dyspareunia and deep dyspareunia on a 11-point numeric rating scale, and the sexual quality-of-life subscale of the Endometriosis Health Profile-30 (0-100%).ResultsThere were 129 patients that met study criteria: one third with pelvic pain and PVD (n = 42) and two-thirds with pelvic pain alone (without PVD) (n = 87). Women with pelvic pain and PVD had significantly more severe superficial dyspareunia ≥7/10 (OR = 12.00 (4.48-32.16), P < .001), more severe deep dyspareunia ≥7/10 (OR = 4.08 (1.83-9.10), P = .001), and poorer sexual quality of life (Endometriosis Health Profile-30 ≥50%) (OR = 4.39 (1.67-11.57), P = .002), compared with the group with pelvic pain alone. Women with pelvic pain and PVD also had more anxiety, depression, and catastrophizing, more frequent tenderness of the bladder and pelvic floor, and more common diagnosis of painful bladder syndrome. On the other hand, there were no significant differences between the 2 groups in terms of dysmenorrhea, chronic pelvic pain, abdominal wall allodynia, positive Carnett test for abdominal wall pain, functional quality of life, endometriosis, and irritable bowel syndrome.ConclusionsIn the pelvic pain population, PVD may be associated with more negative impact on dyspareunia, sexual quality of life, and bladder/pelvic floor function, but it may not significantly impact abdominopelvic pain or day-to-day function in general. Bao C, Noga H, Allaire C, et al. Provoked Vestibulodynia in Women with Pelvic Pain. Sex Med 2019;7:227-234.

Project description:BackgroundProvoked 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.AimsThe 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.MethodsA 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.ResultsTen 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.ConclusionThe 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 registrationClinicalTrials.gov NCT04208204 . Retrospectively registered on December 23, 2019.

Project description:BACKGROUND:Provoked vestibulodynia is the most common form of vulvodynia. Despite its high prevalence and deleterious sexual, conjugal, and psychological repercussions, effective evidence-based interventions for provoked vestibulodynia remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Growing evidence suggests that the central nervous system (CNS) could play a key role in provoked vestibulodynia; thus, treatment targeting the CNS, rather than localized dysfunctions, may be beneficial for women suffering from provoked vestibulodynia. In this study, we aim to build on the promising results of a previous case report and evaluate whether transcranial direct-current stimulation, a non-invasive brain stimulation technique targeting the CNS, could be an effective treatment option for women with provoked vestibulodynia. METHODS/DESIGN:This single-center, triple-blind, parallel group, randomized, controlled trial aims to compare the efficacy of transcranial direct-current stimulation with sham transcranial direct-current stimulation in women with provoked vestibulodynia. Forty women diagnosed with provoked vestibulodynia by a gynecologist, following a standardized treatment protocol, are randomized to either active transcranial direct-current stimulation treatment for ten sessions of 20 minutes at an intensity of 2 mA or sham transcranial direct-current stimulation over a 2-week period. Outcome measures are collected at baseline, 2 weeks after treatment and at 3-month follow-up. The primary outcome is pain during intercourse, assessed with a numerical rating scale. Secondary measurements focus on the sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction, and the patient's global impression of change. DISCUSSION:To our knowledge, this study is the first randomized controlled trial to examine the efficacy of transcranial direct-current stimulation in women with provoked vestibulodynia. Findings from this trial are expected to provide significant information about a promising intervention targeting the centralization of pain in women with provoked vestibulodynia. TRIAL REGISTRATION:Clinicaltrials.gov, NCT02543593 . Registered on September 4, 2015.

Dataset Information

Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response.

Introduction

Objectives

Methods

Conclusion

Publications

Rationale and design of a multicenter randomized clinical trial of extended release gabapentin in provoked vestibulodynia and biological correlates of response.

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