*From the Departments of Psychiatry and Obstetrics and Gynecology, Joan and Sanford Weill Medical College of Cornell University, New York, New York

Dr. Glazer is a Clinical Associate Professor of Psychology in Psychiatry and in Obstetrics and Gynecology

Address reprint requests to Howard I. Glazer Ph.D. 340 East 63^rd St. #1A, New York, N.Y. 10021

Objective: To determine the long term follow-up status of dysesthetic vulvodynia patients who were asymptomatic at the termination of their treatment using surface electromyography (sEMG) assisted pelvic floor muscle rehabilitation.

Study Design: A chart review of the years 1994-1996 identified 62 patients with a diagnosis of dyesthetic vulvodynia on initial evaluation and who were asymptomatic at the termination of treatment. Forty three of these patients responded to a survey requesting information on their pain, maintenance activities and treatments, daily functioning and sexual status since their treatment termination.

Results: Thirty eight of the 43 patients (88.4%) report experiencing no vulvar pain symptoms since completion of treatment. Three patients report a single episode of pain and two patients report two episodes each of vulvar pain. All five of these patients report the absence of any vulvar pain for a mean period of 19.8 months prior to completion of the survey. One Hundred percent of the 43 dysesthetic vulvodynia patients studied report being pain free a mean of 39.5 months after successful treatment termination. No vulvar pain related treatments or significant restrictions on daily activities are reported. All patients report sexual interest, pleasure and activity.

Conclusion: Surface electromyography assisted pelvic floor muscle rehabilitation is an effective and long term cure in the treatment of dysesthetic vulvodynia.

Keywords: Dysesthetic Vulvodynia, pelvic floor muscle surface electromyography, long term follow-up, biofeedback

Introduction:

Dysesthetic Vulvodynia is a syndrome of unexplained chronic, unprovoked, non-localized vulvar pain characterized by sufferers as burning, stinging, irritation or rawness.^1,2 While the incidence of occurrence of dysesthetic vulvodynia is not well researched it has been reported that dyspareunia and pelvic pain, including dysmenorrhea and irritable bowel, are reported by 46% and 39% respectively, of patients seen in a primary care practice setting.³

A surface electromyographic signal is the algebraic summation of all Motor Unit Action Potentials (MUAPT’s) from all active motor units within the pick-up area of the surface electrode. Using a chronic regional pain model, previous research has demonstrated that several characteristics of the sEMG signal of the pubococcygeal portion of the levator ani muscle can reliably differentiate dysesthetic vulvodynia sufferers from both asymptomatic matched controls⁴ and from pain of acute origins such as infectious sources.⁵ Normalization of the sEMG characteristics of the pubococcygeal muscle in dysesthetic vulvodynia patients can be achieved with daily sEMG assisted muscle exercise using the Glazer Protocol.⁶ It has been demonstrated that the normalization of the sEMG of the pubococcygeal muscle of dysesthetic vulvodynia patients results in 50% of patients becoming totally asymptomatic and an overall self report by patients of 83% symptom reduction.⁶ Since the pathophysiology of dysesthetic vulvodynia is not well understood, a number of empirical treatments have been employed with widely varying outcomes.⁷ A literature search did not reveal any studies that incorporated a long term follow up component in assessing the

clinical efficacy of any treatment regimen. The incidence of relapse following initially successful treatment of chronic pain disorders is reported as ranging from 30% to 60%.⁸ In light of this it is important that any empirical treatment with demonstrated clinical efficacy in the treatment of dysesthetic vulvodynia be subject to long term follow up research. The present study reports a three to five year follow up of dysesthetic vulvodynia patients successfully treated with sEMG assisted rehabilitation of pelvic floor muscles using the Glazer protocol.

A retrospective chart review covering the years 1994 to 1996 was conducted to identify patients who had undergone sEMG assisted pelvic floor muscle rehabilitation for treatment of dysesthetic vulvodynia. A survey was conducted of all those patients who reported being completely asymptomatic for a period of at least three months at the termination of their treatment. Patients with a partial response to treatment were not included in this study. Only patients who did not initiate other treatment modalities during the course of their pelvic floor muscle treatment and who did not suffer from concurrent associated disorders such as interstitial cystitis, irritable bowel syndrome or fibromyalgia were selected for inclusion in the study. Demographic, medical history, vulvar pain, sexual, daily acitivity and previous treatment data were available in the chart. A survey collected patient self report data on vulvar pain symptoms, continued treatments, activities of daily living and sex, on either binary response scales of "yes/no" or on response scales of 0 to 10 (0=least ever, 10=most ever).

Results:

Chart review identified a total of 327 vulvar pain patients who underwent initial pelvic floor muscle sEMG evaluation during the specified three year period. Of those patients undergoing initial evaluation 241 (73.7%) underwent a full course of treatment. This represents a 26.3% treatment dropout rate. The operational criteria for termination of treatment is three successive months with less than 10% change in reported pain and less than 10% change in all pelvic floor muscle sEMG readings, including signal amplitudes, standard deviations, coefficients of variance, recruitment and recovery times and tonic contractile spectral frequencies. All patients completing treatment underwent the Glazer Protocol of sEMG assisted pelvic floor muscle rehabilitaion.⁶ Of the 241 patients completing treatment 118 (48.9%) met criteria on intake for dysesthetic vulvodynia without concurrent regional pain such as vulvar vestibulitis syndrome or urethral syndrome. Of the 118 dysesthetic vulvodynia patients completing treatment 62 (52.5%) met the criteria for inclusion in the study including no significant concurrent medical conditions, no initiation of new treatment modalities during the sEMG pelvic muscle treatment and complete absence of dysesthetic vulvodynia symptoms for a minimum of three months at treatment termination. The survey was completed and returned by 43 (69.3%) of those 62 patients. For these 43 patients the mean treatment duration was 8.7 months, the mean number of office visits was 6.8 and the mean time since completion of treatment was 42.1 months.

Of the 43 patients studied the mean age at onset of sEMG pelvic floor muscle rehabilitation treatment was 36.3 years with a mean duration of dysesthetic vulvodynia symptoms of 52.9 months at a mean self reported pain level of 8.2. None of these patients reported a significant history of medical or psychiatric hospitalizations, major surgeries or chronic illnesses. A mean of 6.3 medical specialists were reported as seen for treatment of their dysesthetic vulvodynia prior to starting sEMG pelvic floor muscle rehabilitation. A mean of 5.2 different treatments were experienced prior to starting sEMG pelvic floor muscle rehabilitation. Of the 43 participants in the study 33 were not using any other treatments during their sEMG pelvic floor muscle rehabilitation, 5 patients were on tricyclics, 4 patients were on a low oxalate diet with citrical, 3 patients were using topical estrace cream and 3 patients reported use of topical anesthetics. All of these treatments had been ongoing for at least three months prior to initiation of sEMG pelvic floor muscle rehabilitation without dosage or use pattern changes.

With respect to continuing maintenance routines and treatments at the time of the survey, 32 of the 43 patients (74.42%) studied report continued active avoidance of possible vulvar irritants such as soaps, shampoos and laundry detergents. Eight of the 43 patients (18.60%) studied report continued avoidance of foods which they had previously associated with intensification of their vulvar symptoms. Seven of the 43 patients (16.28%) report the continuation of once a week pelvic floor muscle exercises with surface electromyography feedback. None of the patients studied report the use of either prescription or nonprescription medications relating to their dysesthetic vulvodynia. No patients report the initiation of new treatments.

The three levels of data, initial evaluation, treatment termination, and survey report, for each of the variables, vulvar pain, daily activity restrictions and sex variables, were analyzed using a repeated measure analysis of variance and univariate F-tests comparing each of the levels with each other level. Figure 1 graphically shows the data for each variable at each measurement time. Table 1 shows the univariate F-tests comparing each measurement time with each other measurement time for each variable.

Vulvar Pain:

Five of the 43 patients surveyed (11.6%) reported experiencing any symptoms of dysesthetic vulvodynia since the termination of treatment. The remaining 38 patients (88.4%) report experiencing no vulvar pain symptoms since completion of treatment. Three of the five patients experiencing symptoms report a single episode of pain, of mild degree with a mean self reported pain level of 3.7, with a mean duration of 8.3 days, all occurring within the first six months following treatment termination and all were self-resolving with no treatment. No associated causes were identified in two of these patients and the third patient associated the cause with use of topical antifungal therapy. The remaining patients report two episodes each of vulvar pain with a mean duration of 17.7 days, mean pain intensity rating of 5.1, with all episodes associated with identified causes of vulvar irritation and all self resolving. For one patient both episodes were reported to be related to recurrent urinary tract infections and for the other patient one episode was reported to be associated with use of topical antifungals and the other episode was reported to be associated with prolonged intercourse. All five patients reporting vulvar pain since treatment termination report the complete absence of vulvar pain for a mean period of 19.8 months prior to completion of the survey. One Hundred percent of the 43 dysesthetic vulvodynia patients studied report being pain free at the time of survey for a mean of 39.5 months after successful treatment termination. Mean vulvar pain levels reported at initial evaluation, treatment termination and at the time of the survey were 8.2, 0, and 0 respectively, F(2, 84)= 62.81, P<.001. Univariate F-tests indicate that the level of pain reported at initial evaluation were significantly higher than that reported at treatment termination or at the time of survey which in turn did not differ significantly from each other.

Daily Activities Restrictions:

With respect to daily functions and activities, seven of the 43 patients (16.28%) reported that they had not returned to all their usual activities prior to the initial onset of their vulvar pain. However, six of these patients reported that not returning to previous activities constituted choices in change of lifestyle, not related to vulvar pain. One patient reported that she had not returned to horseback riding because it continued to cause vulvar irritation. Mean levels of daily activity restriction were reported as 7.9, 1.7 and 0.2 at initial evaluation, treatment termination and survey report respectively, F(2, 84)= 39.18, P<.001. Univariate F-tests indicated that each report time differed significantly from each other report time.

Sexual Data:

Three of the 43 patients (6.98%) indicated that they are not presently intercourse active. All three patients related this status to the absence of a partner. For the 40 patients of the 43 (93.08%) surveyed who are presently intercourse active on a regular basis the mean reported intercourse pain is zero. All 43 patients respond that they are regularly involved in non penatrative sexual activity either with a partner or masturbation. The mean pain report for non penatrative sexual activity is zero. Sexual variables measured include dyspareunia, interest, frequency and satisfaction of sexual activity. While the term dyspareunia is more frequently associated with vulvar vestibulitis syndrome, it is used here to describe the exacerbation of vulvar dysesthesia symptoms experienced during penile-vaginal intercourse. Mean levels of reported dyspareunia, including only those patients intercourse active at all three measurement times, were 7.6, 0 and 0 at initial evaluation, termination of treatment and survey respectively, F(2, 68) = 49.83, P<.001. Univariate F-tests indicate that dyspareunia was higher on initial intake than either treatment termination or survey report which in turn do not differ significantly from each other.

Mean levels of reported sexual interest were 3.8, 6.3 and 8.1 respectively for initial evaluation, treatment termination and survey, F(2, 84)=18.59, P<.001. Univariate F-tests indicate that each level differs significantly from each other level.

Mean levels of reported sexual frequency were 2.9, 5.3 and 7.7 respectively for initial

evaluation, treatment termination and survey, F(2, 84)=23.17, P<.001. Univariate F-tests indicate that each level differs significantly from each other level.

Mean levels of reported sexual satisfaction were 1.8, 5.9 and 7.5 respectively for initial evaluation, treatment termination and survey, F(2, 84)=31.02, P<.001. Univariate F-tests indicate that each level differs significantly from each other level.

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 Discussion:

Both vulvar pain and introital dyspareunia are reported as zero in the population studied. This is an interesting report in light of the fact that in the normal population baseline rates of reports of vulvar discomfort and introital dyspareunia do occur at some rate considerably above zero.⁸ The likely explanation for this phenomenon is that the zero

anchoring point on the zero to ten scale is defined as "least ever" rather than as zero. Thus patients reporting zero on the vulvar pain and introital dyspareunia scales mean that they have returned to their pre vulvodynia baseline experience as they recall it. It is worthy of note that for activity restrictions and sexual frequency, interest and satisfaction measures, patients show statistically significant improvement not only from pre-treatment to post-treatment but also from post-treatment to survey measures. Thus, even though patients report experiencing no significant vulvar pain or introital dyspareunia at treatment termination for at least three months duration, they continued to show some restrictions on their activities and sexual frequency, interest and satisfaction. Each of these measures showed a statistically significant improvement from post-treatment to survey measure. This finding is consistent with clinical experience that even though pain is absent, a considerable period of progressive desensitization is necessary for patients to overcome the anxiety and consequent behavioral restrictions associated with chronic pain

syndromes. Further, unlike the pain ratings which reach terminal levels of zero, or "least ever" pain, functional ratings of daily activities and sexual frequency, interest and satisfaction do not reach ten, or "most ever" status. It is impossible to determine if this lack of full functional recovery reflects lifestyle and age related changes or suggests that long term sufferers of chronic pain disorders take years to fully recover functionally once pain free, or perhaps always experience some residual functional loss from previous years of chronic pain. These findings strongly support the importance of a multimodal approach to vulvodynia, which considers not only the pain status of the patient but also their functional status in regards to daily activities and sexual activities, in defining

successful treatment outcomes.⁹ In summary, this study replicates earlier findings demonstrating clinical efficacy of sEMG pelvic floor muscle rehabilitation for the treatment of dysesthetic vulvodynia⁶ and further demonstrates that this condition does not recur within 3 to 5 years after successful sEMG treatment. Significant functional improvement in daily activities and sexual activity continues well beyond the symptomatic relief of vulvar pain.

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