2020 News from the Research Team Articles

May 2020

Article Summary by IPPS Research Committee Member

Two new publications DO NOT definitely support the use of Botulinum Toxin A in the treatment of pelvic myofascial pain.

1. Meister MR, et al. Effectiveness of Botulinum Toxin for Treatment of Symptomatic Pelvic Floor Myofascial Pain in Women: A Systematic Review and Meta-analysis. Female Pelvic Medicine & Reconstructive Surgery, 2020.
Available free access 

2. Levesque A, et al. Botulinum Toxin Infiltrations Versus Local Anesthetic Infiltrations in Pelvic Floor Myofascial Pain: Multicenter Randomized, double-blind study. Annals of Physical and Rehabilitation Medicine, 2020.
Available free access

Summary:  Botox has been extensively used for several years in the field of pelvic pain due to its action on pelvic muscle spasm. However, the efficacy of Botulinum injections has been controversial because of high cost and lack of high-quality efficacy studies. So far, in 2020, two new studies have been released on this subject.

The first meta-analysis (Meister et al) includes a combination of RCTs, prospective and retrospective observational studies. The authors concluded that a clinically and statistically significant reduction in pain (approximately 20-30 points on a 100m VAS scale) is noted in women who received Botulinum Toxin injections, and that this pain relief was sustained beyond 12 weeks after therapy. They also note smaller but significant improvements in dyspareunia, dyschezia and SF-12 scores, however, no improvements were noted in dysmenorrhea. The main limitation of this review is that it included studies with and without a comparison group and only two of the studies were randomized controlled trials. The authors also failed to mention, that the 2 randomized controlled trials that were included in the analysis, Dessie SG, 2019 and Bartley J, 2019 (data published only in clinicaltrials.gov), albeit they showed that patients improved after injections, they failed to demonstrate that Botulinum was superior to the comparator.

The second study (Levesque et al) was not included in the meta-analysis, likely because it was being published at the same time as the Meister study. However, this was an RCT that included 80 patients who received Botulinum injections vs. local anesthetic injections alone. Here the authors concluded that both groups demonstrated significant pain improvement after injections, however, Botulinum Toxin was not superior to local anesthetic.

Conclusion: the controversy on the efficacy of Botulinum Toxin will continue, however, despite the conclusions of the above meta-analysis, careful review shows that intramuscular injections using Botulinum Toxin are no more effective than injections using local anesthetic or other placebo. Clinicians should continue to perform intramuscular injections using compounds that are available and individualized to the circumstances of each patient. IPPS encourages future RCTs to better inform our treatment options.


April 2020

Article Summary by IPPS Research Committee Member - Dr. Ana Lucia Herrera Bentacourt (Colombia)

Botulinum Toxin Infiltrations Versus Local Anesthetic Infiltrations in Pelvic Floor Myofascial Pain: Multicenter, Randomized, Double-blind Study

Levesque, A., Ploteau, S., Michel, F., Siproudhis, L., Bautrant, E., Eggermont, J., Rabischong, B., Volteau, C., Perrouin-Verbe, M. A., & Labat, J. J.
Annals of physical and rehabilitation medicine, S1877-0657(20)30029-4.

Summary:  Botulinum toxin has been extensively used for several years in the field of pain, due to its action on muscle spasm. However, the efficacy of botulinum toxin in the context of chronic pelvic pain remains controversial. This multicenter, randomized, controlled, double-blind study was designed to compare the efficacy of botulinum toxin and local anesthetic (LA) injection versus LA injection alone for pelvic floor myofascial syndrome and chronic pelvic pain. According to the number of painful trigger points detected on physical examination, the patients received from 1 to 4 injections of botulinum toxin with LA (BTX) or LA alone. The primary endpoint was Patient Global Impression of Improvement (PGI-I) score on day 60 after infiltration. Secondary endpoints were pain intensity, number of painful trigger points on palpation, analgesic drug consumption and quality of life. The authors included 80 patients, 40 in each group. This study failed to demonstrate a significant difference between the 2 groups on day 60 in the primary endpoint or secondary endpoints (PGI-I score≤2=20% [LA] versus 27.5% [BTX], P=0.43). However, both groups showed significant alleviation of global pain. This study does not justify the use of botulinum toxin in the context of chronic pelvic pain with myofascial syndrome but does justify muscle injections with LA alone..

Full article available HERE.


March 2020

Article Summary by IPPS Research Committee Member

Incidence and Risk Factors for Pelvic Pain After Mesh Implant Surgery for the Treatment of Pelvic Floor Disorders

Elizabeth J. Geller,* Emma Babb, Andrea G. Nackley, and Denniz Zolnoun
J Minim Invasive Gynecol. 2017 Jan 1; 24(1): 67–73.

Summary:  The aim of this study was to assess incidence and risk factors for pelvic pain after pelvic mesh implantation. This was a retrospective study of women who have undergone surgery with pelvic mesh implant for treatment of pelvic floor disorders including prolapse and incontinence. Pain was measured by the McGill Short-Form Pain Questionnaire for somatic pain, Neuropathic Pain Symptom Inventory for neuropathic pain, Pennebaker Inventory of Limbic Languidness for somatization, and Female Sexual Function Index (FSFI) for sexual health and dyspareunia. General health was assessed with the 12-item Short-Form Health Survey. Among 160 enrolled women, mean time since surgery was 20.8 ± 10.5 months, mean age was 62.1 ± 11.2 years, 93.8% were white, 86.3% were postmenopausal, and 3.1% were tobacco users. Types of mesh included midurethral sling for stress incontinence (78.8%), abdominal/robotic sacrocolpopexy (35.7%), transvaginal for prolapse (6.3%), and perirectal for fecal incontinence (1.9%), with 23.8% concomitant mesh implants for both prolapse and incontinence. Our main outcome, self-reported pelvic pain at least 1 year after surgery, was 15.6%. Women reporting pain were younger, with fibromyalgia, worse physical health, higher somatization, and lower surgery satisfaction (all p < .05). Current pelvic pain correlated with early postoperative pelvic pain (p < .001), fibromyalgia (p = .002), worse physical health (p = .003), and somatization (p = .003). Sexual function was suboptimal (mean FSFI, 16.2 ± 12.1). Only 54.0% were sexually active, with 19.0% of those reporting dyspareunia. The authors concluded that 1 in 6 women reported de novo pelvic pain after pelvic mesh implant surgery, with decreased sexual function. Risk factors for denovo pain included younger age, fibromyalgia, early postoperative pain, poorer physical health, and somatization.

Full article available HERE.


February 2020

Article Summary by IPPS Research Committee Member

Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials.

Haller H, Lauche R, Sundberg T, Dobos G, Cramer H.
BMC Musculoskeletal Disorders, 2020; 21:1

Summary: The objective of this systematic review and meta-analysis was to assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. The authors identified 10 RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain. CST showed greater post intervention effects on: pain intensity (SMD = -0.32, 95%CI = [- 0.61,-0.02]) and disability (SMD = -0.58, 95%CI = [- 0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD = -0.63, 95%CI = [- 0.90,-0.37]) and disability (SMD = -0.54, 95%CI = [- 0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD = -0.53, 95%CI = [- 0.89,-0.16]) and disability (SMD = -0.58, 95%CI = [- 0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD = -0.59, 95%CI = [- 0.99,-0.19]) and disability (SMD = -0.53, 95%CI = [- 0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. The authors concluded that in patients with chronic pain, CST significantly improves pain and function lasting up to six months. . 

Full article available HERE.


January 2020

Article Summary by IPPS Research Committee Member

Pharmacological Interventions for Treating Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Franco JV1, Turk T, Jung JH, Xiao YT, Iakhno S, Tirapegui FI, Garrote V, Vietto V.
Cochrane Database Syst Rev. 2019

Summary: Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is characterized as pelvic pain and lower urinary tract symptoms. This systematic review aimed to assess the efficacy of pharmacological therapies for CP/CPPS, which is considered a complex and multifactorial disorder. In the review, the authors included randomized controlled trials conducted in men a diagnosis of CP/CPPS. They evaluated all available pharmacological interventions compared to placebo or in head-to-head comparisons. The authors identified 99 unique studies assessing 16 types of pharmacological therapies. Overall, they found low- to very low-quality evidence that alpha blockers, antibiotics, 5-ARI, anti-inflammatories, phytotherapy, intraprostatic BTA injection, and traditional Chinese medicine may cause a reduction in prostatitis symptoms without an increased incidence of adverse events in the short term, except for alpha blockers which may be associated with an increase in mild adverse events. There were few trials with active comparators and little evidence of the effects of these drugs on sexual dysfunction, quality of life or anxiety and depression. 

Full article available HERE.


Archived Research News

2019 Research News