Uterine botulinum toxin injections in severe dysmenorrhea, dyspareunia and chronic pelvic pain: Results on quality of life, pain level and medical consumption.

OBJECTIVE: To evaluate quality of life (Qol), pain level and medical consumption before and after uterine botulinum toxin (BT) injections in severe dysmenorrhea, dyspareunia and chronic pelvic pain. METHODS: This was a before and after study using the database of a pilot study (Open-label non comparative study, on 30 patients, with severe dysmenorrhoea in therapeutic failure) assessing efficacy and cost of uterine injection of BT in women with chronic pelvic pain after failure of conventional treatment (hormonal and analgesics) (CT). Main clinical outcome: Patient Global Impression of Improvement (PGI-I), EuroQol health-related QoL (EQ-5D-5L), EuroQol-visual analogue scale (EQ-VAS), Female Sexual Function Index (FSFI), utility measure of health-related quality of life (also called health state preference values), cost and of health care consumption were collected prospectively and analysed in the two phases (before and after). The two timepoints were 12 months before uterine BT injection, when the patient had been receiving CT, and 12 months after uterine BT injection. RESULTS: Median visual analogue scale scores were significantly improved by BT regarding the patients' main source of pain (31.6 vs 80.55; p < 0.00001). We also noted a significant reduction in the proportion of patients who reported dyspareunia [15 (75%) vs 3 (15%) patients, p = 0.001] and pain during menstruation (p < 0.0001). The PGI-I scale showed a significant increase in the proportion of patients who were satisfied with their treatment after receiving the BT injection. The injection of BT was frequently associated with increase in QoL and a reduction in health care consumption, and cost: 714.82 €+/- €336.43 (BT) versus 1104.16 €+/- €227.37 (CT), which could result in substantial savings approximately (389,34€) per patient. CONCLUSION: This study revealed the clinical effectiveness of BT injections on dysmenorrhea, chronic pelvic pain as well as reduction of cost and health care consumption, in our population, which is innovative since no standard of treatment exists in this domain.

Recommendations on the management of pudendal nerve entrapment syndrome: A formalised expert consensus.

BACKGROUND: Since the development and publication of diagnostic criteria for pudendal nerve entrapment (PNE) syndrome in 2008, no comprehensive work has been published on the clinical knowledge in the management of this condition. The aim of this work was to develop recommendations on the diagnosis and the management of PNE. METHODS: The methodology of this study was based on French High Authority for Health Method for the development of good practice and the literature review was based on the PRISMA method. The selected articles have all been evaluated according to the American Society of Interventional Pain Physicians assessment grid. RESULTS: The results of the literature review and expert consensus are incorporated into 10 sections to describe diagnosis and management of PNE: (1) diagnosis of PNE, (2) patients advice and precautions, (3) drugs treatments, (4) physiotherapy, (5) transcutaneous electrostimulations (TENS), (6) psychotherapy, (7) injections, (8) surgery, (9) pulsed radiofrequency, and (10) Neuromodulation. The following major points should be noted: (i) the relevance of 4+1 Nantes criteria for diagnosis; (ii) the preference for initial monotherapy with tri-tetracyclics or gabapentinoids; (iii) the lack of effect of opiates, (iv) the likely relevance (pending more controlled studies) of physiotherapy, TENS and cognitive behavioural therapy; (v) the incertitudes (lack of data) regarding corticoid injections, (vi) surgery is a long term effective treatment and (vii) radiofrequency needs a longer follow-up to be currently proposed in this indication. CONCLUSION: These recommendations should allow rational and homogeneous management of patients suffering from PNE. They should also allow to shorten the delays of management by directing the primary care. SIGNIFICANCE: Pudendal nerve entrapment (PNE) has only been known for about 20 years and its management is heterogeneous from one practitioner to another. This work offers a synthesis of the literature and international experts' opinions on the diagnosis and management of PNE.

Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study.

BACKGROUND: Many studies have demonstrated a link between pelvic floor myofascial syndromes and chronic pelvic pain. Botulinum toxin has been extensively used for several years in the field of pain, especially due to its action on muscle spasm. However, the efficacy of botulinum toxin in the context of chronic pelvic pain remains controversial. OBJECTIVES: This multicentre, randomized, controlled, double-blind study was designed to compare the efficacy of botulinum toxin and local anaesthetic (LA) injection versus LA injection alone for pelvic floor myofascial syndrome and chronic pelvic pain. METHODS: According to the number of painful trigger points detected on physical examination, 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. RESULTS: We 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. CONCLUSION: 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. ClinicalTrials.gov: NCT01967524.

Treatment of acute dysmenorrhoea and pelvic pain syndrome of uterine origin with myometrial botulinum toxin injections under hysteroscopy: A pilot study.

BACKGROUND: Acute dysmenorrhoea in women which has been shown to be anatomically negative for endometriosis is a very common condition. It is frequently associated with Chronic Pelvic Pain (CPP) from uterine origin, including painful uterine contractions and deep dyspareunia. We call this association Painful Uterine Syndrome (PUS). SEARCH STRATEGY: In these women in failure of the usual treatments, we proposed a new treatment, with Uterine Toxin Botulinic injections (BTX) under hysteroscopy, as a compassionate option, among women in severe pain and therapeutic failure. Indeed, increased uterine contractility has been confirmed using cine magnetic resonance imaging in patients with acute dysmenorrhea and PUS. These findings, associated with the hypothesis of a possible uterine sensitization on the same model as irritable bowel syndrome (IBS) or painful bladder syndrome (PBS), led to the application of botulinum toxin (BTX) injections under hysteroscopy of the uterine myometrium in this indication. MATERIAL AND METHODS: In 2018, we conducted an open-label non comparative study, on 30 patients, with severe dysmenorrhea and PUS in therapeutic failure situation. All women had failure of usual treatments, with painkillers, anti-inflammatory drugs, contraceptive pill, menstrual suppressant therapy and a negative MRI and laparoscopy. The BTX units (200 IU of Incobotulinum-toxin A) were evenly distributed in the anterior and posterior myometrial wall under hysteroscopic control. Patients were reviewed between 8 and 12 weeks after BTX injections and then, at 6 months. MAIN RESULTS: Median VAS scores were significantly improved at 8-12 weeks follow up for dysmenorrhoea, deep dyspareunia, and pelvic pain outside of menstruation. Quality of life scores all improved dramatically. No major side effect has been reported in this pilot study. At 6 months, 12 patients (40 %), were given new injections for pain reccurence. But 14 patients (47 %), were still improved and did not require repeat injection at that time. 4 patients, were improvement was not significant, did not ask for repat BTX injections. These patients were all positive for Pelvic Sensitization criteria. CONCLUSIONS: Uterine BTX injection could be a very interesting therapeutic option in women with acute dysmenorrheoa and PUS in therapeutic failure. Only long-term randomised studies will be able to confirm that BTX injections are useful as a treatment for this condition. The randomised long-term study, Uteroxine, will shortly release its results.

Evaluation of diagnostic accuracy of Colour Duplex Scanning, compared to electroneuromyography, diagnostic score and surgical outcomes, in Pudendal Neuralgia by entrapment: a prospective study on 96 patients.

The objective of our study is to evaluate the detection capacity of Colour Duplex Scanning (CDS) in helping to diagnose Pudendal Neuralgia (PNa) by Pudendal Nerve Entrapment (PNE). This technique is being compared to complete Neurological Criteria (NC) based on Diagnostic Score (DS) and Electroneuromyography (ENMG) and secondly, to the results of surgery. This is a prospective study, on a consecutive series of 96 unselected patients evaluated by both CDS and NC. The CDS examinations were performed by the same operator who was unaware of the NC. The DS and the ENMG were read by a practitioner who was unaware of the CDS findings. The Peak Systolic Velocity (PSV) and the Systolic Ascension Time (AT) were the vascular criteria. Inadequate examinations were neither repeated nor removed from the analysis. Of 166 Internal Pudendal Arteries (IPAs) explored by CDS, 163 were visualised on their whole course, leading to a 98% feasibility. Of the 67 PNE identified by NC, 60 cases of Pudendal Vascular Entrapment (PVE) were detected by CDS, leading to a 89.6% sensitivity and a 67.4% specificity. Currently, there is no gold standard that can diagnose PNa by PNE with certainty. CDS is a non-invasive technique, demonstrating high diagnostic value to confirm PNE. In this study, we determined a new objective diagnostic criterion, the Pudendal Artery Ratio (PAR), which is very strong at diagnosing PNE but needs to be validated by further studies.