The Use of Amielle Vaginal Trainers as Adjuvant in the Treatment of Vestibulodynia: An Observational Multicentric Study

Abstract

Objective

To assess the effectiveness of a specific set of vaginal dilators (Amielle Comfort) as a part of vestibulodynia therapy.

Study design

Fifteen women referred for vestibulodynia, localized vulvodynia, were advised to use vaginal dilators (Amielle Comfort) accompanied by standardized instructions, after previously receiving 1 or more therapies for the vestibulodynia.

Results

The post-treatment Marinoff scale for dyspareunia significantly improved in patients after vaginal dilator treatment compared with baseline values (2.2 ± 0.4 vs 1.1 ± 0.9; P < .01), and the Female Sexual Function Index scores were significantly improved compared with the prestudy values (16.3 ± 5.5 vs 25.3 ± 7.5; P < .01).

Conclusion

Among women with previous therapy for vestibulodynia, vaginal dilator use was associated with improvement in symptoms. Vaginal dilators can play an important role in overcoming pelvic floor muscular responses that remain and sometimes increase after pain perception has decreased.

Introduction

Vulvodynia is defined as vulvar discomfort, most often described as burning pain, occurring in the absence of relevant visible findings or a specific, clinically identifiable neurologic disorder.[1] The most common pain pattern in women with vulvodynia includes symptoms localized strictly to the vulvar vestibule: localized vulvodynia or vestibulodynia.

Symptoms can take the form of burning and any combination of stinging, irritation, itching, pain, and dyspareunia. Introital dyspareunia, the intensity of which may inhibit or prevent intercourse, is often the presenting symptom. The etiology of vestibulodynia is not established. The prevailing theory is that vestibulodynia is a neuropathic disorder involving abnormal pain perception[2]; dysfunction of the pelvic floor muscles may be a component.[3] Multiple treatments have been used for vulvodynia, including vulvar care measures; topical, oral, and injectable medications; biofeedback; physical therapy; a low-oxalate diet and calcium citrate supplementation; and surgery.[1] Treatment is directed toward alleviating symptoms and may provide partial or complete relief. Although some patients experience relief with a particular treatment regimen, others may not respond to it or experience unacceptable side effects. No single treatment is appropriate for every patient, and it may take a considerable amount of time to find a treatment or combination of treatments that will alleviate the pain. Vaginal dilators are used in a variety of clinical situations, including the treatment of vaginismus, avoidance of vaginal adhesion, and stenosis following radiation therapy.[4] In this study, we report the evaluation of a particular set of vaginal dilators (Amielle Comfort) as a part of vestibulodynia therapy.

Material and Methods

The study population consisted of women who were referred to 3 different outpatient departments of vulvar disease for the evaluation and treatment of chronic vulvar symptoms. Patients were entered in this controlled trial once the diagnosis of vestibulodynia was established on the basis of the following criteria: (1) history of vulvar pain with tampon insertion or attempted intercourse, (2) tenderness upon palpation of the vestibular area with a cotton tip applicator, (3) exclusion of other causes for these findings, and (4) symptoms lasting at least 6 months. At the first visit, all women underwent an interview about medical history, medication, and obstetric/gynecologic history. On the same occasion, and again after completing the cycle of treatment (after 8 weeks), symptoms were assessed. We also administered the Female Sexual Function Index (FSFI), a 19-item questionnaire developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women.[5] Dyspareunia was recorded and graded 0–3 according to the Marinoff dyspareunia scale.[6] Vulvoscopy and cultures of the vagina for Candida, Trichomonas vaginalis, bacteria, Chlamydia trachomatis, Mycoplasma, and Ureoplasma were also performed. The gynecologic examination included the Q-tip test. Each patient, after receiving one of more therapies for the vestibulodynia (Table 1), was advised to use the vaginal dilators (Amielle Comfort) with the following standardized instructions:

• Insert the first dilator (the smallest one), while lying flat on your back, into your vagina as deep as is comfortable and leave it in position for 10 minutes. Follow 3 series from 8 movements in and out without completely removing the dilator from the vagina. This sequence should be repeated 3 times a week for the first 2 weeks.

• Insert the first dilator and leave it in position for 5 minutes; then insert the second dilator and leave it in position for 10 minutes. Follow 3 series from 8 movements in and out without completely removing the dilator from the vagina. This sequence should be repeated 3 times a week for the third and fourth weeks.

• Insert the first and the second dilators and leave them in position for 5 minutes; then insert the third dilator and leave it in position for 10 minutes. Follow 3 series from 8 movements in and out without completely removing the dilator from the vagina. This sequence should be repeated 3 times a week for the fifth and sixth weeks.

• Insert the second and the third dilators and leave them in position for 5 minutes; then insert the fourth dilator and leave it in position for 10 minutes. Follow 3 series from 8 movements in and out without completely removing the dilator from the vagina. This sequence should be repeated 3 times a week for the seventh and eighth weeks.

Table 1.

Vestibulodynia Therapies Used in Association With Amielle Dilators

Therapies	Patients*
Trancutaneous electrical nerve stimulation (TENS)	8 of 15
Vestibular infiltration	4 of 15
Biofeedback and pelvic floor exercises	7 of 15
Amitriptyline and pregabalin	6 of 15

^*Some patients used more than 1 therapy.

Fifteen patients, whose ages ranged from 23 to 55 years (mean, 32.9), were enrolled in the study. EPI-INFO version 6.0 (US Centers for Disease Control and Prevention, Atlanta, Georgia) was used for all statistical analyses. The changes in the FSFI and dyspareunia scores were analyzed with Student's t-test. Statistical significance was set at P < .05.

Results

The post-treatment Marinoff scale for dyspareunia significantly improved in patients after vaginal dilator (Amielle Comfort) treatment compared with baseline values (Table 2). Evaluation of pretreatment FSFI values suggested that the study population had significantly lower “health-related” scores compared with the general population without sexual disorders. The prestudy scores were 16.3 ± 5.5 compared with the general population of 26.5, which is considered the optimal cutoff score for differentiating women with and without sexual dysfunction.[7] The FSFI scores were significantly improved compared with the prestudy values (P < .01) (Table 2).

Table 2.

Pretreatment (Baseline) and Post-Treatment Scores of Dyspareunia and Female Sexual Function Index (FSFI)

	Pretreatment	Post-treatment	P Value
Dyspareunia	2.2 ± 0.4	1.1 ± 0.9	.001
FSFI	16.3 ± 5.5	25.3 ± 7.5	.001

Data are means ± SD

Discussion

Most women who used the vaginal dilators noted symptomatic improvement. Vestibulodynia disrupts intimate relationships and causes great distress. In the illness, recovery often involves some pelvic muscle hypertonicity, manifested as voluntary guarding and high muscle tension. This differs from the variables of pelvic floor muscle instability at rest, and poor muscle recovery after contraction differentiated some vestibulodynia-afflicted women from controls.[3] In many patients sex has been painful for a long time or the woman has not had sex for a long time due to the pain. As a result, she may have developed some negative feelings toward sex, or possibly her relationship with her partner. We define this condition as secondary vaginismus. These pelvic floor muscular responses remain and sometimes increase after the pain perception has decreased, as postulated to result from sensitization of the vestibular nerve fibers.[8] The affected tissue is hyperalgesic to thermal, tactile, and pressure stimuli, sometimes involving a hyperpathic “after pain” that lasts for minutes after stimulus removal.[2] The role of pelvic floor muscles, especially the pubococcygeus muscle group, is such that once they are triggered, they continue to cause involuntary tightness with attempts at intercourse. The body has learned to expect or anticipate pain upon penetration, so that the pubococcygeus muscle contracts to protect against the potential of intercourse pain. Therefore, we used the vaginal dilators as a part of vestibulodynia therapy. The Amielle vaginal dilators, beginning with a diameter no larger than 3/4 in (19 mm), range upward gradually to the size of a man's fully erect penis. With time, the insertion becomes comfortable, and the couple should be encouraged to include penile-vulvar stimulation during sexual play so that the woman becomes accustomed to feeling the penis on her vulva. We have found that standardized and easy-to-follow instructions are very important for clinical success. Treatment steps can usually be completed at home using a self-help approach, allowing a woman to work at her own pace in privacy. Graduated vaginal insertion exercises allow women to comfortably transition to the stage at which they are ready for intercourse without pain or discomfort. Our study results confirm that no single treatment is appropriate for every patient. Vulvodynia is a complex disorder that frequently is frustrating to both the clinician and the patient; treatment is directed toward alleviating symptoms and may provide partial or complete relief. In this scenario, according to our opinion, the Amielle vaginal dilatators can play an important role.