Skip Navigation LinksHome > July 2003 - Volume 102 - Issue 1 > Overnight 5% Lidocaine Ointment for Treatment of Vulvar Vest...
Obstetrics & Gynecology:
Original Research

Overnight 5% Lidocaine Ointment for Treatment of Vulvar Vestibulitis

Zolnoun, Denniz A. MD, MPH; Hartmann, Katherine E. MD, PhD; Steege, John F. MD

Free Access
Article Outline
Collapse Box

Author Information

Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.

Address reprint request to: Denniz Zolnoun, MD, MPH, CB#7570, University of North Carolina, School of Medicine, Chapel Hill, NC 27599-7570; E-mail: denniz_zolnoun@med.unc.edu.

The authors thank Dr. David Grimes, Vice-President of Medical Affairs, Family Health International, for his substantive comments and editorial assistance in the preparation of the manuscript.

Received December 13, 2002. Received in revised form January 17, 2003. Accepted February 6, 2003.

Collapse Box

Abstract

OBJECTIVE: To assess the effectiveness of nightly application of 5% lidocaine ointment for treatment of vulvar vestibulitis.

METHODS: Over 17 months, we assessed women presenting to our pain clinic for evaluation of introital pain; 61 women met the criteria for vulvar vestibulitis and participated in a treatment trial. We measured daily pain and intercourse-related pain using a 100-mm visual analog scale. We compared ability to have intercourse and pain ratings before and after treatment, and investigated whether prior treatment or gynecologic comorbidities predicted response to treatment.

RESULTS: After a mean of 7 weeks of nightly treatment, 76% of women reported ability to have intercourse, compared with 36% before treatment (P = .002). Intercourse-related pain score was 39.11 (95% confidence interval [CI] 30.39, 47.83) points lower after treatment (P < .001), with a decrease of 10.37 (95% CI 3.53, 17.21) points in daily pain score (P = .004). We found no association between response to prior episodic use of lidocaine and response to nightly therapy with lidocaine ointment. Few patient characteristics predicted response to treatment; however, women with interstitial cystitis and other vulvar conditions were least likely to benefit.

CONCLUSION: Long-term, nightly application of 5% lidocaine ointment shows promise as a treatment for management of vulvar vestibulitis; a randomized, double-blind, clinical trial is warranted.

Since its description by Skene more than a century ago, vulvar vestibulitis has been an elusive disorder with poorly understood etiology, pathophysiology, and treatment.1 In 1987, Friedrich proposed the first clinical diagnostic criteria for vulvar vestibulitis: severe pain on vestibular touch and entry dyspareunia, tenderness to pressure localized within the vestibule, and physical findings limited to erythema of various degrees.2,3 The pain may be present only during attempted coitus and/or during other daily activities. The population prevalence of vulvar vestibulitis is unknown; a single study of 210 consecutively evaluated gynecology patients in a community setting reported that 15% of women met criteria for vulvar vestibulitis.4

Though vulvar vestibulitis is likely common, the optimal therapy is unknown. Treatments studied have included long-term fluconazole and topical cromolyn, interferon alpha-2b injection, cognitive behavioral therapy, vestibuloplasty, and laser treatment. Of these, the most promising to date have been cognitive behavioral therapy, with 20–38% reduction in pain scores,5 and vestibuloplasty, with 60–89% of patients reporting satisfaction with pain reduction and/or sexual function after surgery.5–7

We have been intrigued with the degree to which vulvar vestibulitis shares characteristics of other neuroinflammatory conditions such as postherpetic neuralgia. In such pain syndromes, initial nerve injury provokes sensitization of nociceptors and perpetuates release of neuropeptides that maintain an inflammatory process.8,9 As in postherpetic neuralgia, women with vulvar vestibulitis demonstrate allodynia (perception of pain from nonpainful stimuli) and respond variably to treatment.8–11 Long-term use of lidocaine skin patches has led to improvement of pain in patients with postherpetic neuralgia. By analogy, we sought to investigate extended use of topical anesthetic treatment of vulvar vestibulitis. The objective of our study was to describe the response of women with vulvar vestibulitis to treatment with nightly application of 5% lidocaine ointment.

Back to Top | Article Outline

MATERIALS AND METHODS

Between November 1999 and March 2001, we evaluated all women referred to the University of North Carolina Pelvic Pain Clinic for management of vulvar pain for eligibility for enrollment. This study was approved by the Institutional Review Board of the University of North Carolina School of Medicine. All patients referred for evaluation of vulvar pain had a standardized history and physical examination. After completion of the history, they were asked to rate their discomfort level during daily activity and attempted intercourse using a pencil and paper 100-mm visual analog scale.

We performed comprehensive physical examinations for all women using a standardized form to record findings. We used a cotton-tipped applicator to touch the labia majora, labia minora, and the vestibule, and recorded the presence or absence of allodynia, sensory loss, and any visible inflammatory changes. We diagnosed vulvar vestibulitis using Friedrich criteria.3 All women with the diagnosis of vulvar vestibulitis and mixed diagnoses were offered enrollment in the study.

Upon establishing the diagnosis, we instructed the study participants on the proper application of the ointment. Using a mirror, we reviewed the anatomy of the involved area with the patients. Patients were instructed to apply a copious amount of 5% lidocaine ointment to the affected area at bedtime and were asked to place a cotton ball generously coated with the 5% lidocaine ointment in the vestibule to assure continuing overnight application. We instructed patients to use the treatment nightly, for 8 or more hours.

We obtained repeat visual analog scale scores for pain with daily activity and pain with intercourse at the follow-up visit scheduled 6–8 weeks after initiation of treatment. Patients were also asked about ability to have intercourse at both the initial and the follow-up visit. Patients were defined as able to have intercourse if they reported any intercourse during a given month, regardless of frequency or degree of discomfort. Those who were celibate because of severity of symptoms were defined as unable to have intercourse. Regardless of the patients' compliance with treatment, or subsequent additional diagnoses, the data for all the patients who met criteria, were offered treatment, and kept their clinical follow-up appointment visit were analyzed.

We used chart review, telephone interview, and direct interview to obtain and confirm additional demographic information. Long-term response to treatment was assessed by sending a follow-up questionnaire and visual analog scale rating a minimum of 6 months after the initiation of treatment.

The primary outcome was a change in daily and intercourse-related visual analog scale scores with treatment. Because sexual dysfunction is the primary concern for patients, we also assessed patients' self-reported ability to have intercourse, and examined the dichotomous outcome of achieving a 50% reduction in intercourse-related pain after treatment. We performed univariate descriptive tabulations and bivariate analyses. Paired t tests were used to assess changes in continuous outcomes; Pearson χ2 and exact tests were used for categoric data.

Back to Top | Article Outline

RESULTS

A total of 71 patients were offered treatment. Of these patients, two declined treatment and eight patients had no clinical follow-up data available. This report is based on the remaining 61 patients. The average patient age was 30 ± 6 years, most were white, and the majority had been evaluated by at least one physician for their symptoms (Table 1). Before their initial visit to our clinic, the participants had seen a mean of three different physicians over an average interval of 32 months (range 5–216) since the onset of symptoms. Our primary diagnosis was vulvar vestibulitis in 47 women (77%). Thirteen women (23%) had other concomitant diagnoses (four had vaginismus; three, culture-proven chronic recurrent yeast infection; one, recurrent herpes; one, lichen sclerosis; one, proctalgia fugax; one, obsessive-compulsive disorder involving genital cleansing; and one, postepisiotomy perineoplasty pain).

Table 1
Table 1
Image Tools

Most women had tried other treatments, including topical medications (lidocaine 2% used episodically, estrogen cream, metronidazole gel, antifungal cream, corticosteroid cream, and trichloroacetic acid), amitriptyline, oral herbal remedies, and operations (laser ablation, revision of episiotomy, and vestibuloplasty).

Nightly topical 5% lidocaine ointment was associated with an improvement in symptoms in the majority of women. After a mean of 7 weeks' treatment, the daily pain rating was 10.37 (95% confidence interval [CI] 3.53, 17.21) points lower than in pretreatment (P = .004). The intercourse-related pain score was 39.11 (95% CI 30.39, 47.83) points lower after treatment, P < .001 (Table 2). Seventy-six percent of women reported ability to have intercourse after treatment compared with 36% at the initial visit (P = .002). We found no association between prior episodic use of lidocaine and response to nightly treatment. Duration of symptoms, presence of endometriosis, and symptom onset associated with childbirth were not related to response to treatment. The presence of interstitial cystitis and other concomitant vulvar disease was significantly associated with failure to benefit from treatment, P = .001 and P = .05, respectively.

Table 2
Table 2
Image Tools

If we define a 50% or greater decline in pain with intercourse as successful treatment, 57% (36 of 61) achieved this level of success. Women with interstitial cystitis were more than two-fold less likely to respond to treatment (relative risk 2.61; 95% CI 1.05, 6.51), as were those with other vulvar diseases (relative risk 2.1; 95% CI 0.95, 4.63). Other factors examined were not associated with response to lidocaine. Forty-nine percent (30 of 61) of women returned the 6-month follow-up questionnaire. Among those with follow-up information, 77% (23 of 30) reported ongoing use of 5% lidocaine ointment (12 patients were using it infrequently, several times a week, weekly or less). Of the remaining seven patients who stopped using 5% lidocaine, 86% (six of seven) reported sustained improvement in their symptoms and ability to have intercourse.

Back to Top | Article Outline

DISCUSSION

Most women treated with topical lidocaine 5% ointment, applied nightly, noted improvement in symptoms. The majority had tried other medications without relief. This treatment is simple, safe, and inexpensive (approximately $10 for a 35-g tube). We patterned our regimen after the initial trial done by Rowbotham and Fields using 5% lidocaine under a dressing for a 12-hour period for treatment of postherpetic neuralgia.12 Given the anatomic difficulty of covering the vestibular region, we devised an approach using a medication-coated cotton ball. The cotton ball remains in place overnight and is well tolerated. No protective undergarment is required. Some patients experience transient burning after application, lasting about 15 seconds.

This before-and-after study benefits from prospective use of a simple but well-validated pain assessment technique using consistent records and treatment instructions by a small team of physicians. Nonetheless, we realize that placebo response and patient desire to report favorable results to the clinical care team may account for some of the observed benefits. However, given the persistence of this patient population in seeking relief when not improved (averaging three prior physicians) and the severity of initial presentation compared with follow-up examinations, we believe that a placebo or emollient effect is unlikely to have accounted for the full extent of symptom relief observed. We also recognize the comparatively brief time window for evaluation of the duration of treatment effect. Follow-up is often difficult in referral populations13; as such, we have limited ability to assess the longer-term efficacy of this treatment given suboptimal return of 6-month questionnaires.

The potential mechanism of action of 5% topical lidocaine in treating this condition is unknown. Histologic studies show a proliferation of C-fibers (which carry pain sensation) and the presence of calcitonin gene-related peptide (commonly seen with nerve irritation) in vulvar vestibulitis patients.9,11 In addition, patients with vulvar vestibulitis have abnormalities of sensory perception, such as heat and touch.8 Lidocaine blocks transmission of C-fibers. Continuous exposure to lidocaine inhibits “irritable nociceptors” and is the purported mechanism by which it provides benefit in treatment of chronic pain.14 We postulate that lidocaine's slow onset of action and moderate duration makes it a potentially useful treatment for chronic pain disorders such vulvar vestibulitis.

Topical and injected local anesthetics have been found effective in treating post-herpetic neuralgia.12 Some patients using topical anesthetics attain sustained relief, whereas others many need to continue treatment for many years to maintain pain relief.15 In this group with severe symptoms, lidocaine has been the only beneficial treatment. In such patients, adverse events and tachy-phylaxis to lidocaine patch therapy have not been seen with long-term use.

Our patients with interstitial cystitis tended to have involvement of anterior vestibule, characterized by exquisite allodynia. Furthermore, two of the six women with interstitial cystitis reported numbness (these two had severe cystitis for many years), or limited perception of touch on the labia minora at presentation. These patients were least likely to respond to our treatment regimen. Women with severe allodynia over the anterior vestibule tended to not respond as well to the treatment. Those with prior surgery responded favorably to the treatment as long as the area of allodynia and tenderness was limited to the posterior vestibule. This before-and-after study suggests nightly topical lidocaine therapy improves symptoms in women with refractory vulvar vestibulitis. Although information bias and placebo effect may have accounted for some of the observed benefit, we doubt that these could account for the substantial benefit seen in most patients. Indeed, after therapy, the proportion of patients who could have coitus doubled. Based on this series, we believe that a randomized controlled trial is warranted to test these encouraging preliminary results.

Back to Top | Article Outline

REFERENCES

1. Marinoff SC, Turner ML. Vulvar vestibulitis syndrome: An overview. Am J Obstet Gynecol 1991;165:1228–33.

2. Baggish MS, Miklos JR. Vulvar pain syndrome: A review. Obstet Gynecol Surv 1995;50:618–27.

3. Friedrich EG Jr. Vulvar vestibulitis syndrome. J Reprod Med 1987;32:110–4.

4. Goetsch MF. Vulvar vestibulitis: Prevalence and historic features in a general gynecologic practice population. Am J Obstet Gynecol 1991;164:1609–14.

5. Bergeron S, Binik YM, Khalife S, Pagidas K, Glazer HI, Meana M, et al. A randomized comparison of group cognitive–behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain 2001;91:297–306.

6. Bornstein J, Zarfati D, Goldik Z, Abramorici H. Perineoplasty compared with vestibuloplasty for severe vulvar vestibulitis (see comments). Br J Obstet Gynaecol 1995; 102:652–5.

7. McCormack WM, Spence MR. Evaluation of the surgical treatment of vulvar vestibulitis. Eur J Obstet Gynecol Reprod Biol 1999;86:135–8.

8. Bohm-Starke N, Hilliges M, Brodda-Jansen G, Rylander E, Torebjork E. Psychophysical evidence of nociceptor sensitization in vulvar vestibulitis syndrome. Pain 2001; 94:177–83.

9. Bohm-Starke N, Hilliges M, Falconer C, Rylander E. Neurochemical characterization of the vestibular nerves in women with vulvar vestibulitis syndrome. Gynecol Obstet Invest 1999;48:270–5.

10. Bohm-Starke N, Hilliges M, Blomgren B, Falconer C, Rylander E. Increased blood flow and erythema in the posterior vestibular mucosa in vulvar vestibulitis (1). Obstet Gynecol 2001;98:1067–74.

11. Bohm-Starke N, Hilliges M, Falconer C, Rylander E. Increased intraepithelial innervation in women with vulvar vestibulitis syndrome. Gynecol Obstet Invest 1998;46:256–60.

12. Rowbotham MC, Fields HL. Topical lidocaine reduces pain in post-herpetic neuralgia. Pain 1989;38:297–301.

13. Klonoff-Cohen HS, Savitz DA, Cefalo RC, McCann MF. An epidemiologic study of contraception and preeclampsia. JAMA 1989;262:3143–7.

14. Fields HL, Rowbotham M, Baron R. Postherpetic neuralgia: Irritable nociceptors and deafferentation. Neurobiol Dis 1998;5:209–27.

15. Galer BS, Rowbotham MC, Perander J, Friedman E. Topical lidocaine patch relieves postherpetic neuralgia more effectively than a vehicle topical patch: Results of an enriched enrollment study. Pain 1999;80:533–8.

Cited By:

This article has been cited 31 time(s).

Gynecologie Obstetrique & Fertilite
2013 vulvodynia update
de Belilovsky, C
Gynecologie Obstetrique & Fertilite, 41(9): 505-510.
10.1016/j.gyobfe.2013.06.008
CrossRef
Hautarzt
Vulvodynia
Hengge, UR; Runnebaum, IB
Hautarzt, 56(6): 556-559.
10.1007/s00105-005-0970-1
CrossRef
Family Process
Vulvar pain: A phenomenological study of couples in search of effective diagnosis and treatment
Connor, JJ; Robinson, B; Wieling, E
Family Process, 47(2): 139-155.

British Journal of Dermatology
Guidelines for the management of vulvodynia
Mandal, D; Nunns, D; Byrne, M; McLelland, J; Rani, R; Cullimore, J; Bansal, D; Brackenbury, F; Kirtschig, G; Wier, M
British Journal of Dermatology, 162(6): 1180-1185.
10.1111/j.1365-2133.2010.09684.x
CrossRef
Journal of Sexual Medicine
Surgical treatment of vulvar vestibulitis syndrome: Outcome assessment derived from a postoperative questionnaire
Goldstein, AT; Klingman, D; Christopher, K; Johnson, C; Marinoff, SC
Journal of Sexual Medicine, 3(5): 923-931.
10.1111/j.1743-6109.2006.00303.x
CrossRef
Pelvi-Perineologie
Medical treatment of pudendal neuralgia
Riant, T; Labat, JJ; Lassaux, A; Robert, R; Kalfahlah, M; Guerineau, M
Pelvi-Perineologie, 3(3): 250-257.
10.1007/s11608-008-0203-z
CrossRef
Journal of Sexual Medicine
Women's Sexual Pain Disorders
van Lankveld, JJDM; Granot, M; Schultz, WCMW; Binik, YM; Wesselmann, U; Pukall, CF; Bohm-Starke, N; Achtrari, C
Journal of Sexual Medicine, 7(1): 615-631.
10.1111/j.1743-6109.2009.01631.x
CrossRef
Archives of Sexual Behavior
The optimal discipline for assessing and managing pain during sex
Basson, R
Archives of Sexual Behavior, 34(1): 23-+.
10.1007/s10508-005-0999-3
CrossRef
Journal of Reproductive Medicine
A qualitative study of women with vulvodynia II. Response to a multidisciplinary approach to management
Munday, P; Buchan, A; Ravenhill, G; Wiggs, A; Brooks, F
Journal of Reproductive Medicine, 52(1): 19-22.

Journal of Midwifery & Womens Health
Vulvar pain syndromes: Vestibulodynia
Stone-Godena, T
Journal of Midwifery & Womens Health, 51(6): 502-509.
10.1016/j.jmwh.2006.08.010
CrossRef
American Journal of Obstetrics and Gynecology
Multilevel local anesthetic nerve blockade for the treatment of vulvar vestibulitis syndrome
Rapkin, AJ; McDonald, JS; Morgan, M
American Journal of Obstetrics and Gynecology, 198(1): -.
ARTN 41.e1
CrossRef
Obstetrics and Gynecology
Pelvic Pain Phenotyping The Key to Progress
Steege, JF
Obstetrics and Gynecology, 113(2): 258-259.

Behaviour Research and Therapy
Provoked vestibulodynia: Psychological predictors of topical and cognitive-behavioral treatment outcome
Desrochers, G; Bergeron, S; Khalife, S; Dupuis, MJ; Jodoin, M
Behaviour Research and Therapy, 48(2): 106-115.
10.1016/j.brat.2009.09.014
CrossRef
British Medical Journal
Vulval vestibulitis - Is a common and poorly recognised cause of dyspareunia
Munday, P; Buchan, A
British Medical Journal, 328(): 1214-1215.

Menopause-the Journal of the North American Menopause Society
Recent advances in women's sexual function and dysfunction
Basson, R
Menopause-the Journal of the North American Menopause Society, 11(6): 714-725.
10.1097/01.GME.0000138542.65917.FB
CrossRef
American Family Physician
Vulvodynia: Diagnosis and management
Reed, BD
American Family Physician, 73(7): 1231-1238.

Acta Obstetricia Et Gynecologica Scandinavica
EMG biofeedback versus topical lidocaine gel: a randomized study for the treatment of women with vulvar vestibulitis
Danielsson, I; Torstensson, T; Brodda-Jansen, G; Bohm-Starke, N
Acta Obstetricia Et Gynecologica Scandinavica, 85(): 1360-1367.
10.1080/00016340600883401
CrossRef
Journal of Sexual Medicine
Vulvodynia
Goldstein, AT; Burrows, L
Journal of Sexual Medicine, 5(1): 5-15.

Acta Obstetricia Et Gynecologica Scandinavica
Vulvodynia. Definition, diagnosis and treatment
Petersen, CD; Lundvall, L; Kristensen, E; Giraldi, A
Acta Obstetricia Et Gynecologica Scandinavica, 87(9): 893-901.
10.1080/00016340802323321
CrossRef
Lancet
Vulvoldynia
Lotery, HE; McClure, N; Galask, RP
Lancet, 363(): 1058-1060.

American Journal of Obstetrics and Gynecology
Capsaicin for the treatment of vulvar vestibulitis
Steinberg, AC; Oyama, IA; Rejba, AE; Kellogg-Spadt, S; Whitmore, KE
American Journal of Obstetrics and Gynecology, 192(5): 1549-1553.
10.1016/j.ajog.2004.10.626
CrossRef
Journal of Reproductive Medicine
Vulvodynia - A state-of-the-art consensus on definitions, diagnosis and management
Bachmann, GA; Rosen, R; Pinn, VW; Utian, WH; Ayers, C; Basson, R; Binik, YM; Brown, C; Foster, DC; Gibbons, JM; Goldstein, I; Graziottin, A; Haefner, HK; Harlow, BL; Spadt, SK; Leiblum, SR; Masheb, RM; Reed, BD; Sobel, JD; Veasley, C; Wesselmann, U; Witkin, SS
Journal of Reproductive Medicine, 51(6): 447-456.

Journal of Sexual Medicine
Effectiveness of hypnosis for the treatment of vulvar vestibulitis syndrome: A preliminary investigation
Pukall, C; Kandyba, K; Amsel, R; Khalife, S; Binik, Y
Journal of Sexual Medicine, 4(2): 417-425.
10.1111/j.1743-6109.2006.00425.x
CrossRef
Clinical Obstetrics and Gynecology
Vulvodynia: Strategies for Treatment
Goldstein, AT; Marinoff, SC; Haefner, HK
Clinical Obstetrics and Gynecology, 48(4): 769-785.

PDF (255)
Clinical Obstetrics and Gynecology
Sexual Pain
BOARDMAN, LA; STOCKDALE, CK
Clinical Obstetrics and Gynecology, 52(4): 682-690.
10.1097/GRF.0b013e3181bf4a7e
PDF (109) | CrossRef
The Clinical Journal of Pain
The Treatment of Provoked Vestibulodynia: A Critical Review
Landry, T; Bergeron, S; Dupuis, M; Desrochers, G
The Clinical Journal of Pain, 24(2): 155-171.
10.1097/AJP.0b013e31815aac4d
PDF (173) | CrossRef
The Clinical Journal of Pain
The Result of Treatment on Vestibular and General Pain Thresholds in Women With Provoked Vestibulodynia
Bohm-Starke, N; Brodda-Jansen, G; Linder, J; Danielsson, I
The Clinical Journal of Pain, 23(7): 598-604.
10.1097/AJP.0b013e318122d1fc
PDF (138) | CrossRef
Current Opinion in Obstetrics and Gynecology
Vulvodynia
Smart, OC; MacLean, AB
Current Opinion in Obstetrics and Gynecology, 15(6): 497-500.

PDF (77)
Obstetrics & Gynecology
Topical Gabapentin in the Treatment of Localized and Generalized Vulvodynia
Boardman, LA; Cooper, AS; Blais, LR; Raker, CA
Obstetrics & Gynecology, 112(3): 579-585.
10.1097/AOG.0b013e3181827c77
PDF (411) | CrossRef
Obstetrical & Gynecological Survey
A Conceptual Model for the Pathophysiology of Vulvar Vestibulitis Syndrome
Zolnoun, D; Hartmann, K; Lamvu, G; As-Sanie, S; Maixner, W; Steege, J
Obstetrical & Gynecological Survey, 61(6): 395-401.
10.1097/01.ogx.0000219814.40759.38
PDF (419) | CrossRef
Journal of Lower Genital Tract Disease
Topical Amitriptyline-Baclofen Cream for the Treatment of Provoked Vestibulodynia
Nyirjesy, P; Lev-Sagie, A; Mathew, L; Culhane, JF
Journal of Lower Genital Tract Disease, 13(4): 230-236.
10.1097/LGT.0b013e31819663ee
PDF (95) | CrossRef
Back to Top | Article Outline

© 2003 The American College of Obstetricians and Gynecologists

Login

Article Tools

Images

Share