Oral Desipramine and Topical Lidocaine for Vulvodynia

Foster, David C.; Kotok, Merrill Beth; Huang, Li‐Shan; Watts, Arthur; Oakes, David; Howard, Fred M.; Poleshuck, Ellen L.; Stodgell, Christopher J.; Dworkin, Robert H.

doi:10.1097/aog.0b013e3181e9e0ab

Cited by 170 publications

(147 citation statements)

References 25 publications

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“…Other studies using lidocaine showed improvement in pain and sexual function. However, when comparing lidocaine to other treatments, its efficacy was found nonsignificantly different than biofeedback in the study of Danielsson et al [27] and desipramine and/or placebo in the study of Foster et al [28]. The latter's posology and technique of application differed from those of Zolnoun et al [26], which may explain the lower efficacy.…”

Section: Introductionmentioning

confidence: 89%

“…In the most conservative scenario, a sample of 170 participants (85 per group) would be necessary. To account for an expected drop-out rate of 20% after 6 months [18] and [28], 212 participants (170/0.80) need to be enrolled at baseline. This number provides sufficient power to meet the secondary objectives with power ranging from 84.4-99.9%.…”

Section: Sample Sizementioning

confidence: 99%

“…With regard to the topical application of lidocaine, we also intended to reflect current clinical practice. Overnight application of lidocaine 5% ointment was selected in our trial as this protocol has shown the highest efficacy so far [26] compared to daily application of lidocaine [27] and [28]. Application of lidocaine before intercourse has been described in clinical guidelines [16] and [17], but no data are yet available to support its efficacy.…”

Section: Choice Of Interventionsmentioning

confidence: 99%

“…In fact, to achieve the treatment's objective to target PFM function, an 8-to 12-week training period is generally recommended [67]. As for lidocaine application, previous studies report treatment periods ranging from 7 weeks of an overnight application [26] to 12 weeks of a 4-7 times daily application [27] and [28]. Since the overnight application was chosen in this study, a 10-week treatment is in accordance with previous studies and allows uniformity in the length of the two treatments.…”

Section: Duration Of Interventionsmentioning

confidence: 99%

“…The latter's posology and technique of application differed from those of Zolnoun et al [26], which may explain the lower efficacy. In fact, Danielsson et al [27] instructed women to apply lidocaine 2% and 5% five to seven times per day while Foster et al [28] recommended four-five daily applications of lidocaine 2% or 5% diluted in hydrating cream. Overnight lidocaine 5% may represent a better treatment option but its efficacy has never been investigated using a rigorous RCT design.…”

Section: Introductionmentioning

confidence: 99%

See 4 more Smart Citations

Randomized clinical trial of multimodal physiotherapy treatment compared to overnight lidocaine ointment in women with provoked vestibulodynia: Design and methods

Morin

Dumoulin

Bergeron

et al. 2016

Contemporary Clinical Trials

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Provoked vestibulodynia (PVD) is a highly prevalent and debilitating condition yet its management relies mainly on non-empirically validated interventions. Among the many causes of PVD, there is growing evidence that pelvic floor muscle (PFM) dysfunctions play an important role in its pathophysiology. Multimodal physiotherapy, which addresses these dysfunctions, is judged by experts to be highly effective and is recommended as a first-line treatment. However, the effectiveness of this promising intervention has been evaluated through only two small uncontrolled trials. The proposed bi-center, single-blind, parallel group, randomized controlled trial (RCT) aims to evaluate the efficacy of multimodal physiotherapy and compare it to a frequently used first-line treatment, topical overnight application of lidocaine, in women with PVD. A total of 212 women diagnosed with PVD according to a standardized protocol were eligible for the study and were randomly assigned to either multimodal physiotherapy or lidocaine treatment for 10 weeks. The primary outcome measure is pain during intercourse (assessed with a numerical rating scale). Secondary measures include sexual function, pain quality, psychological factors (including pain catastrophizing, anxiety, depression and fear of pain), PFM morphology and function, and patients' global impression of change. Assessments are made at baseline, post-treatment and at the 6-month follow-up. This manuscript presents and discusses the rationale, design and methodology of the first RCT investigating physiotherapy in comparison to a commonly prescribed first-line treatment, overnight topical lidocaine, for women with PVD.

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Section: Introductionmentioning

confidence: 89%

Section: Sample Sizementioning

confidence: 99%