Pilot study of botulinum toxin type A in the treatment of chronic pelvic pain associated with spasm of the levator ani muscles (original) (raw)
Related papers
Obstetrics and gynecology, 2006
To estimate whether botulinum toxin type A is more effective than placebo at reducing pain and pelvic floor pressure in women with chronic pelvic pain and pelvic floor muscle spasm. This study was a double-blinded, randomized, placebo-controlled trial. All participants presented with chronic pelvic pain of more than 2 years duration and evidence of pelvic floor muscle spasm. Thirty women had 80 units of botulinum toxin type A injected into the pelvic floor muscles, and 30 women received saline. Dysmenorrhea, dyspareunia, dyschezia, and nonmenstrual pelvic pain were assessed by visual analog scale (VAS) at baseline and then monthly for 6 months. Pelvic floor pressures were measured by vaginal manometry. There was significant change from baseline in the botulinum toxin type A group for dyspareunia (VAS score 66 versus 12; chi2 = 25.78, P < .001) and nonmenstrual pelvic pain (VAS score 51 versus 22; chi2 = 16.98, P = .009). In the placebo group only dyspareunia was significantly red...
Botulinum toxin injection for chronic pelvic pain: A systematic review
Acta Obstetricia et Gynecologica Scandinavica, 2020
Introduction: Botulinum toxin has proven therapeutic effects in alleviating pain in several myofascial disorders, with an expanding potential in chronic pelvic pain. The objective of this systematic review is to evaluate the efficacy and safety of botulinum toxin injection as an off-label treatment for female chronic pelvic pain. Material and methods: Using PRISMA guidelines, MEDLINE, EBM Reviews, PubMed, CINAHL, TRIP Database, EMBASE, Web of Science and gray literature were searched. Studies assessing the efficacy of botulinum toxin for chronic pelvic pain in adult females, with 10 or more women, published in English up to January 13, 2020, were included. All eligible studies were reviewed and data was extracted by two independent reviewers using a standardized form. Quality of evidence was graded using the Cochrane Risk of Bias 2 tool for randomized controlled trials and the Ottawa-Newcastle scale for observational studies. Results: 491 records were screened. 17 articles were included in the final review: five randomized controlled trials and twelve observational studies. The quality of evidence ranged from low to high. There was a large degree of heterogeneity in study designs, and thus a meta-analysis was not feasible. All observational studies concluded that botulinum toxin was an effective treatment for chronic pelvic pain, with the greatest change in visual analog scale from 8.69 at baseline to 3.07 at 24 months post-injection. However only one of the five randomized controlled trials found statistical significant differences Accepted Article This article is protected by copyright. All rights reserved favouring botulinum toxin in the reporting of the EQ-5D [botulinum 0.78 (0.69-1.00), control 0.69 (0.25-0.81), P=0.03], and frequency of intercourse [botulinum 1(1-1.75), placebo 1(0-1), P = 0.025)]. The most common adverse effect was transient localized pain at injection site (6-88%). No serious adverse events were reported. Conclusions: Although observational studies were encouraging, there is insufficient high quality evidence to recommend botulinum toxin injection for chronic pelvic pain. However, its safety of use can be reassured. Future studies of higher quality in its treatment efficacy are indicated. KEYWORDS Chronic pelvic pain, myofascial pain, vulvodynia, dyspareunia, botulinum toxin ABBREVIATIONS CPP chronic pelvic pain RCT randomized controlled trial VAS visual analog scale KEY MESSAGE There is currently insufficient high quality evidence to recommend botulinum toxin injection for chronic pelvic pain.
LUTS: Lower Urinary Tract Symptoms, 2020
Chronic pelvic pain (CPP) is an extremely bothersome condition which leads to major effects in women's everyday life. In addition to visceral sources of pain, pelvic floor dysfunction including myofascial pain and spasm on the pelvic floor muscles causing hypertonicity are causes often overlooked. Injecting botulinum toxin type A (BoNT-A) into hypertonic pelvic floor muscles may aid the relaxation of pelvic floor musculature. The muscles that are injected in CPP treatment include the obturator internus, levator ani (pubococcygeus, iliococcygeus, and puborectalis), and coccygeus. Generally, injections can be performed tolerably with safety under conscious sedation combined with local anesthesia. Most practitioners perform BoNT-A injection of pelvic floor muscles using anatomical landmarks identified by manual palpation only. For the precise location of injection sites, some needle guidance techniques were proposed, including electromyography, electrical stimulation, ultrasound, fluoroscopy, and/or computed tomography. Side effects of BoNT-A injection in CPP are rare and self-limiting. Because of the reversible nature of BoNT-A, reinjection appears to be necessary. Increasing proof points out that BoNT-A is a promising treatment option for CPP in women. We conducted a review of published literature in Pubmed, using chronic pelvic pain in women, hypertonic pelvic floor, and botulinum toxin as the keywords. This article aims to summarize the treatment techniques and results of BoNT-A injection for hypertonic pelvic floor in women with chronic pelvic pain. K E Y W O R D S botulinum toxin, chronic pelvic pain, hypertonic pelvic floor, treatment technique 1 | INTRODUCTION Chronic pelvic pain (CPP) is a common disorder which affects roughly 15% of women. It is a complex and usually multifactorial condition affecting more than just the pelvis. 1 Considerable emphasis is placed on diagnostic laparoscopy because of the difficulty in the identification and treatment of endometriosis, pelvic adhesions, and postinflammatory changes. In addition to visceral pain, nearly 23% of women with CPP have myofascial pain. 2 The complex muscular system of the pelvis has multiple functions such as micturition, defecation, sexual intercourse, and childbirth. Patients may present with storage or voiding urinary symptoms, bowel symptoms, or sexual dysfunction. 3-6 Pelvic floor disorder should be viewed as one of the causes of CPP in women. Spasticity of the pelvic floor muscle is a motor disorder characterized by a rise in muscle tone. 7 High-tone pelvic floor dysfunction (HT-PFD) is often seen in women with CPP and vestibulodynia. 8 The abnormally prolonged muscle contraction may result in compression of the vessels of the muscle and lead to ischemic change. Muscle contractions with oxygen deficiency that activates muscle nociceptors are
Botulinum Toxin Treatment of Pelvic Floor Disorders and Genital Pain in Women
Current Women's Health Reviews, 2008
Background and Objective Botulinum neurotoxin (BoNT), now commonly used for reducing muscular spasms in other neuromuscular disorders, is now increasingly proposed also for treating pelvic floor disorders, including chronic pelvic pain syndromes, vaginismus, vulvodynia and vulvar vestibulitis syndrome. To provide up-to-date information on these advances we reviewed the literature about Bunt injections for pain and spasms related to pelvic floor disorders. Methods We conducted a Medline search using the terms botulinum neurotoxin, pelvic floor disorders, levator ani myalgia, vaginismus, vulvar vestibulitis , vulvodynia, dyspareunia, interstitial cystitis, recurrent cystitis, and postcoital cystitis. We sought information on the indications and techniques used for Bunt treatment for pelvic floor dysfunctions, and related pain syndromes in women. Results Our search identified 12 studies for review (including a randomized controlled trial) showing that Bunt effectively reduces pain in chronic genital pain syndromes associated with pelvic floor spasm. Before Bunt trials, patients with idiopathic lifelong vaginismus and dyspareunia, associated with hyperactive pelvic floor muscles, had no effective treatment options. Bunt injected under electromyographic (EMG) guidance in pelvic floor muscles improves vaginismus, helping to restore a normal sexual life. Bunt injections also seem to improve vulvodynia and vulvar vestibulitis. Though some patients need periodic injections, in about 65% of affected women BoNT achieves permanent benefit. Conclusions These encouraging evidence-based results suggest that BoNT injected intramuscularly should extend treatment options for women with lifelong or acquired pelvic floor disorders and genital pain.
Using botulinum toxin for pelvic indications in women
Australian and New Zealand Journal of Obstetrics and Gynaecology, 2009
Background: Botulinum toxin (BoNT) is a potent neurotoxin. Its ability to cause muscle paralysis is increasingly being utilised for the management of a number of conditions of interest to the gynaecologist. Aims: This review aims to give the reader an overview of the use of BoNT for conditions presenting a management challenge for the gynaecologist, such as chronic pelvic pain and idiopathic detrusor overactivity. Methods: The literature was reviewed regarding the use, side-effects and complications of BoNT in the pelvis, focussing on chronic pelvic pain, provoked vestibulodynia, conditions involving the lower gastrointestinal tract and detrusor overactivity. Results: In terms of pain caused by pelvic floor spasm, daily pelvic pain and dyspareunia are the symptoms most likely to be improved by BoNT. Limited data regarding use for provoked vestibulodynia indicate an improvement in pain scores. In the lower gastrointestinal tract, injection into puborectalis has been showed to objectively improve intravaginal pressures, though there are no randomised controlled trials (class I studies) validating its use in this setting. Class I studies demonstrate a role for BoNT in the management of idiopathic detrusor overactivity, though long-term follow-up data are lacking. Potential problems with BoNT injection include toxin reactions, urinary and faecal incontinence, urinary retention and secondary treatment failure due to antibody production. Conclusions: A single class I study supports the use of BoNT for refractory pelvic floor spasm; however, further adequately powered class I studies for this indication and for provoked vestibulodynia are warranted.
Botulinum Toxin for the Treatment of Genital Pain Syndromes
Gynecologic and Obstetric Investigation, 2004
Our purpose was to test the effect of botulinum toxin injections on hypertonic pelvic floor muscles of patients suffering from genital pain syndromes. We report two cases of women complaining of a genital pain syndrome resistant to pharmacological therapies and rehabilitation exercises associated with a documented involuntary tonic contraction of the levator ani muscle as a defense reaction triggered by vulvar pain. We performed botulinum toxin injections into the levator ani with the intent to relieve pelvic muscular spasms. Within a few days after the injections both the patients reported a complete resolution of the painful symptomatology, lasting for several months. Our experience suggests that botulinum injections are indicated in patients with genital pain syndrome with documented pelvic muscle hyperactivity, whose symptoms arise not only from genital inflammation and lesions, but also, and sometimes chiefly, from levator ani myalgia.
European urology, 2009
e u r o p e a n u r o l o g y 5 5 ( 2 0 0 9 ) 1 0 0 -1 2 0 a v a i l a b l e a t w w w . s c i e n c e d i r e c t . c o m j o u r n a l h o m e p a g e : w w w . e u r o p e a n u r o l o g y . c o m Abstract Context: The increasing body of evidence and number of potential indications for the use of botulinum neurotoxins (BoNTs) in the lower urinary tract (LUT) underlines the pressing need for evidence-based guidelines. Objective: A European expert panel consensus conference was convened with the main aim of evaluating the evidence and clinical considerations for the use of BoNTs in the treatment of urologic and pelvic-floor disorders and to propose relevant recommendations. Evidence acquisition: The quality of evidence from fully published English-language literature in the PubMed and EMBASE databases was assessed using the European Association of Urology (EAU) levels of evidence (LoE). Recommendations were graded and approved by a unanimous consensus of the panel. Evidence synthesis: The use of botulinum neurotoxin type A (BoNTA) is recommended in the treatment of intractable symptoms of neurogenic detrusor overactivity (NDO) or idiopathic detrusor overactivity (IDO) in adults (grade A). Caution is recommended in IDO because the risk of voiding difficulty and duration of effect have not yet been accurately evaluated. Repeated treatment can be recommended in NDO (grade B). The depth and location for bladder injections should be within the detrusor muscle outside the trigone (grade C). Dosage in children should be determined by body weight, with caution regarding total dose if also being used for treatment of spasticity, and minimum age (grade B). Existing evidence is inconclusive for recommendations in neurogenic detrusor-sphincter dyssynergia, bladder pain syndrome, prostate diseases, and pelvic-floor disorders. The use of BoNTA in the LUT with the current dosages and techniques is considered to be safe overall (grade A). Conclusions: The consensus committee recommends larger placebo-controlled and comparative trials to evaluate the efficacy of single and repeat injections, the duration of effect, the optimal dosage and injection technique, the timing for repeat injection, and the short-and long-term safety of the treatment in LUT and pelvic-floor disorders.
Management of Bladder, Prostatic and Pelvic Floor Disorders with Botulinum Neurotoxin
Current Medicinal Chemistry, 2005
Since its introduction in the late 1970s for the treatment of strabismus and blepharospasm, botulinum toxin (BoNT) has been increasingly used in the interventional treatment of several other disorders characterized by excessive or inappropriate muscle contractions. The use of this pluripotential agent has extended to a plethora of conditions including: focal dystonia; spasticity; inappropriate contraction in most sphincters of the body such as those associated with spasmodic dysphonia, esophageal achalasia, chronic anal fissure, and vaginismus; eye movement disorders; other hyperkinetic disorders including tics and tremors; autonomic disorders such as hyperhidrosis; genitourinary disorders such as overactive and neurogenic bladder, nonbacterial prostatitis and benign prostatic hyperplasia; and aesthetically undesirable hyperfunctional facial lines. In addition, BoNT is being investigated for the control of the pain, and for the management of tension or migraine headaches and myofascial pain syndrome. BoNT injections have several advantages over drugs and surgical therapies in the management of intractable or chronic disease. Systemic pharmacologic effects are rare; permanent destruction of tissue does not occur. Graded degrees of relaxation may be achieved by varying the dose injected; most adverse effects are transient. Finally, patient acceptance is high. In this paper, clinical experience over the last years with BoNT in urological impaired patients will be illustrated. Moreover, this paper presents current data on the use of BoNT to treat pelvic floor disorders.
The use of botulinum toxin for the treatment of urologic pain
Current Opinion in Urology, 2013
Purpose of review Botulinum toxin injections into the bladder have become established in the management of refractory detrusor overactivity and overactive bladder. Mechanism of action of the toxin appears to involve both efferent and afferent nerve pathways, as well as having an antinociceptive effect. Over the years, several reports of its use in refractory bladder pain syndrome and interstitial cystitis have emerged. We review the literature with a view to assessing efficacy and adverse events in this setting. Recent findings Small open-labelled studies have suggested botulinum neurotoxin serotype A (BoNT-A) to be an effective treatment for the majority of patients with refractory bladder pain syndrome/interstitial cystitis. A single set of injections result in demonstrable improvements in symptom scores and bladder pain, although some studies suggest repeated injections may be better. BoNT-A is more effective in nonulcer-type patients. In chronic pelvic pain syndrome, a recent placebo-controlled trial showed only a modest benefit for BoNT-A over placebo with a response rate of 30%.