Botulinum toxin injection in vulva and vagina. Evidence from a literature systematic review.

INTRODUCTION: Botulinum toxin (BoNT) administration has been proposed in the gynecologic field for pelvic, vulvar and vaginal disorders. On this regard, we aimed assessing the therapeutic effectiveness and safety of BoNT usage in the treatment of vaginal, vulvar and pelvic pain disorders. METHODS: We searched for all the original articles without date restriction until 31.12.2021. We included all the original articles which administered botulinum toxin in the vulva or vagina of women suffering from vaginismus, dyspareunia, and chronic pelvic pain. Only English language studies and those performed in humans were eligible. We excluded all case reports and pilot study from the qualitative analysis, although we accurately evaluated them. 22 original studies were finally included in the systematic review. RESULTS: Botulinum toxin injection was found to be effective in improving vulvar and vaginal dyspareunia, vaginismus, and chronic pelvic pain. No irreversible side effects were detected. Major side effects reported were transient urinary or fecal incontinence, constipation and rectal pain. The risk of bias assessment proved original articles to be of medium quality. No metanalysis could have been performed since lack of congruency in the definition of pathology and methods of botulinum toxin administration. CONCLUSION: Data extraction pointed out different endpoints and different methods of analysis. Studies focus on different types of participants and use various techniques and timing. According to the best evidence available, different techniques provide evidence about positive outcomes, with the need for a standardized protocol.

Comparative Study of 150 vs. 200 Units of Botulinum Toxin as Treatment for Vaginismus.

OBJECTIVE: To comparatively evaluate the outcome of treatment with 150 versus 200 units (U) of botulinum toxin in achieving pain-free intercourse and relieving muscle contraction in order to allow gynecological examination. METHODS: In this comparative prospective observational study, 99 patients with vaginismus were treated with botulinum toxin injections from September 2016 to August 2021. Diagnosis and grading of vaginismus severity were assessed using a Female Sexual Function Index (FSFI) questionnaire. Under local or general anesthesia, botulinum toxin diluted with preservative-free saline (150 U and 200 U) was injected into, above, and below the right and left bulbospongiosus muscle and the lateral submucosal areas of the introitus and perineal body using an insulin syringe. Patients were recalled after 2 weeks, and the postoperative outcome was recorded using a similar preoperative questionnaire. RESULTS: Overall, the mean age of patients was 30.2 years. The baseline and clinical characteristics were comparable between the 2 groups (p > 0.05). Significant improvements were seen in the pain and anxiety scores of finger penetration, dilator use, intercourse, and cotton swab in individual groups. The intergroup comparisons between 150 U and 200 U of Botox were not statistically significant (p > 0.05). CONCLUSION: Low-dose Botox (150 U) is equally effective as high dose Botox injections (200 U) in vaginismus patients. Therefore, Botox-150 U can be used to treat vaginismus as an alternative to high doses of the same substance.

OBJETIVO: Avaliar comparativamente o resultado do tratamento com 150 versus 200 unidades (U) de toxina botulínica na obtenção de relações sexuais sem dor e no alívio da contração muscular para permitir o exame ginecológico. MéTODOS: Neste estudo observacional prospectivo comparativo, 99 pacientes com vaginismo foram tratadas com injeções de toxina botulínica de setembro de 2016 a agosto de 2021. O diagnóstico e a classificação da gravidade do vaginismo foram avaliados usando um questionário Female Sexual Function Index (FSFI). Sob anestesia local ou geral, injetou-se toxina botulínica diluída em soro fisiológico sem conservantes (150 U e 200 U) nos músculos bulbo esponjoso direito e esquerdo e nas áreas submucosas laterais do intróito e corpo perineal, utilizando-se uma seringa de insulina. Os pacientes foram chamados após 2 semanas, e o resultado pós-operatório foi registrado usando um questionário pré-operatório semelhante. RESULTADOS: No geral, a média de idade dos pacientes foi de 30,2 anos. As características basais e clínicas foram comparáveis entre os 2 grupos (p > 0,05). Melhorias significativas foram observadas nos escores de dor e ansiedade à penetração com dedo, uso de dilatador, relação sexual e cotonete em grupos individuais. As comparações intergrupos entre 150 U e 200 U Botox foram não estatisticamente significativas (p > 0,05). CONCLUSãO: Botox de baixa dose (150 U) é tão eficaz quanto injeções de Botox de alta dose (200 U) em pacientes com vaginismo. Portanto, o Botox-150 U pode ser usado para tratar o vaginismo como alternativa às altas doses da mesma substância.

Methodological approaches to botulinum toxin for the treatment of chronic pelvic pain, vaginismus, and vulvar pain disorders.

INTRODUCTION AND HYPOTHESIS: Botulinum toxin (BoNT) is increasingly used for pain, especially with muscle spasm. We describe our methodology for BoNT treatment of chronic pelvic pain (CPP) in women and place it in the context of the literature on techniques for this use. METHODS: Databases were searched using terms "botulinum toxin," "pelvic pain," and "vaginismus." Reports on vaginismus/vulvodynia/vestibulodynia (included if pelvic floor muscles were injected) were grouped as "vaginismus/vulvar pain disorders" (V/VPD). We analyzed the type of report, condition, toxin serotype/brand, dose/dilution, muscle selection, guidance technique, and anesthesia. Publications from the same authors without unique information were combined for specific analyses. RESULTS: Thirty-eight reports had analyzable information; many lacked complete information. Most were open-label prospective reports; there were four technical reports, one randomized comparison of doses and one placebo-controlled study of efficacy. Pelvic floor muscles were approached transvaginally, transperineally or transgluteally. BoNT brand/dose/dilution varied widely. Muscle localization techniques included anatomical landmarks only, electromyography, electrical stimulation with/without ultrasound, and fluoroscopy/CT scanning. Papers discussing analgesia utilized general anesthesia, conscious sedation with/without topical/local anesthesia, topical/local agent alone or pudendal block before or after injection. Cumulatively, 58-100% of patients with CPP and 71-100% of those with V/VPD improved. Serious adverse events (transient fecal incontinence/constipation, urinary incontinence/retention) were more frequent with higher doses. CONCLUSIONS: BoNT can be safely and tolerably injected into pelvic floor muscles in women as an out-patient procedure. This study identifies methodological factors to be considered in future studies and the critical need for high-quality clinical trials for this emerging treatment.

Botulinum toxin for vaginismus treatment.

BACKGROUND/AIMS: Vaginismus is characterized by recurrent or persistent involuntary contraction of the perineal muscles surrounding the outer third of the vagina when penile, finger, tampon, or speculum penetration is attempted. Recent results have suggested the use of botulinum toxin for the treatment of vaginismus. Here, we assessed previously published data to evaluate the therapeutic effectiveness of botulinum toxin for vaginismus. METHODS: We have carried out a systematic review followed by a meta-analysis. RESULTS: Our results indicate that botulinum toxin is an effective therapeutic option for patients with vaginismus (pooled odds ratio of 8.723 with 95% confidence interval limits of 1.942 and 39.162, p = 0.005). This may hold particularly true in treatment-refractory patients because most of the studies included in this meta-analysis have enrolled these subjects in their primary analysis. CONCLUSION: Botulinum toxin appears to bea reasonable intervention for vaginismus. However, this conclusion should be read carefully because of the deficiency of placebo-controlled randomized clinical trials and the quality issues presented in the existing ones.

Different treatment modalities for refractory vaginismus in western Saudi Arabia.

INTRODUCTION: Although vaginismus is a common sexual dysfunction in Saudi Arabia, there are limited data concerning the treatment modalities associated with patients with symptoms of vaginismus. AIM: This study is aimed to evaluate the presentation and different modalities of management in patients with severe refractory vaginismus in western Saudi Arabia. MAIN OUTCOME MEASURES: Successful penetrative sexual intercourse suggesting that common elements of the therapies used were successful. METHODS: A retrospective study of patients presenting with severe refractory vaginismus treated in Jeddah, Saudi Arabia. The subjects were 15 women with third to fourth degree vaginismus who presented to King Abdulazziz University Hospital between January 1, 2008 and January 1, 2009. RESULTS: The mean age of the participants was 23 years. The mean duration of marriage before seeking medical advice was 12 months. Six patients had undergone conventional therapy successfully. The other six cases, four of which had a previous history of treatment failure, and two who were unresponsive to 4 months of conventional therapy were offered botulinum toxin type A. Five patients who received the Botox therapy had satisfactory intercourse on the same day of the treatment. One patient required a repeat injection after 2 months for recurrent vaginismus. Three of the 15 patients refused the treatment as they were already divorced and had only come in to exclude organic causes for their condition. CONCLUSIONS: Vaginismus is an overlooked topic in conservative societies such as Saudi Arabia. For most patients, not knowing who to confide in or where to turn to plays a major role in the under diagnosis of vaginismus. Conventional therapy proved effective in mild and moderate cases, while botulinum toxin has a more rapid effect and was thus more effective in severe cases.

[Psychogenic purpura with hematuria and sexual pain disorder: a case report]. / Hematüri ve Cinsel Agri Bozuklugunun Eslik Ettigi Psikojenik Purpura; Bir Olgu Sunumu.

Psychogenic purpura (Gardner-Diamond syndrome) is the occurrence and spontaneous recurrence of painful ecchymosis following emotional stress and minor trauma. Although the exact mechanism of this syndrome remains unknown, apart from skin lesions, different types of hemorrhaging have been reported, such as epistaxis, gastrointestinal bleeding, and bleeding from the ear canals and eyes. We report a psychogenic purpura case that presented with hematuria in addition to skin lesions. Based on the psychiatric evaluation she was diagnosed with major depressive disorder, generalized anxiety disorder, and obsessive-compulsive disorder. Additionally, sexual pain disorder accompanied these disorders. With the help of antidepressant and supportive psychotherapy, the patient's ecchymosis and bleeding disappeared. During 8 months of follow-up the symptoms did not return. Vaginismus has not been reported in patients with psychogenic purpura. The presence of vaginismus, which is seen more frequently in eastern cultures and is thought to be related to sociocultural determinants, suggests that some cultural factors may be common to both psychogenic purpura and vaginismus. The aim of this case report was to call attention to a syndrome that is rarely seen and diagnosed, and to discuss its relationship to psychosocial factors. This syndrome should be considered in the differential diagnosis of not only ecchymotic lesions, but also various types of bleeding, including hematuria. Despite the fact that its etiology and treatment are not clearly understood, it should be noted that psychological factors play a role in this disease and therefore, psychopharmacological and psychotherapeutic approaches can be effective.

Successful use of botulinum toxin type a in the treatment of refractory postoperative dyspareunia.

BACKGROUND: Refractory dyspareunia presents a challenging therapeutic dilemma. CASE: A woman with defecatory dysfunction and dyspareunia presented with stage 2 prolapse. She underwent laparoscopic and vaginal pelvic floor reconstruction with excision of endometriosis. The patient experienced increased dyspareunia and de novo vaginismus postoperatively that were refractory to trigger point injections, physical therapy, and medical and surgical management. She underwent botulinum toxin type A injections into her levator ani muscles, which allowed her to have sexual intercourse again after 2 years of apareunia with no recurrence of pain for 12 months. CONCLUSION: Injecting botulinum toxin into the levator ani muscles shows promise for postoperative patients who develop vaginismus and do not respond to conservative therapy.

Botulinum neurotoxin type A injections for vaginismus secondary to vulvar vestibulitis syndrome.

OBJECTIVE: To investigate whether botulinum neurotoxin type A improves vaginismus and study its efficacy with repeated treatments. METHODS: Outpatients were referred because standard cognitive-behavioral and medical treatment for vaginismus and vulvar vestibular syndrome failed. From this group, we prospectively recruited consecutive women (n=39) whose diagnostic electromyogram (EMG) recordings from the levator ani muscle showed hyperactivity at rest and reduced inhibition during straining. These women were followed for a mean (+/-standard deviation) of 105 (+/-50) weeks. Recruited patients underwent repeated cycles of botulinum neurotoxin type A injected into the levator ani under EMG guidance and EMG monitoring thereafter. At enrollment and 4 weeks after each cycle, women were asked about sexual intercourse; underwent EMG evaluation and examinations to grade vaginal resistance according to Lamont; and completed a visual analog scale (VAS) for pain, the Female Sexual Function Index Scale, a quality-of-life questionnaire (Short-Form 12 Health Survey), and bowel and bladder symptom assessment. RESULTS: At 4 weeks after the first botulinum neurotoxin type A cycle, the primary outcome measures (the possibility of having sexual intercourse, and levator ani EMG hyperactivity) both improved, as did the secondary outcomes, Lamont scores, VAS, Female Sexual Function Index Scales, Short-Form 12 Health Survey, and bowel-bladder symptoms. These benefits persisted through later cycles. When follow-up ended, 63.2% of the patients completely recovered from vaginismus and vulvar vestibular syndrome, 15.4% still needed reinjections (censored), and 15.4% had dropped out. CONCLUSION: Botulinum neurotoxin type A is an effective treatment option for vaginismus secondary to vulvar vestibular syndrome refractory to standard cognitive-behavioral and medical management. After patients received botulinum neurotoxin type A, their sexual activity improved and reinjections provided sustained benefits. LEVEL OF EVIDENCE: III.

Topical lignocaine for vaginismus: a case report.

Vaginismus is a sexual dysfunction in which spasm of vaginal musculature precludes penetrative intercourse. In many cases associated pain or fear of pain may contribute to the maintenance of vaginismus. We report a case of primary vaginismus with associated pain that benefited from topical application of lignocaine gel along with systematic desensitization resulting in successful consummation, and suggest that it may be a useful adjunct during finger dilatation in the treatment of vaginismus, specifically in patients who have associated pain or areas of hyperesthesia in the introitus.