Characterization of Pelvic Floor Activity in Healthy Subjects and with Chronic Pelvic Pain: Diagnostic Potential of Surface Electromyography.

Chronic pelvic pain (CPP) is a highly disabling disorder in women usually associated with hypertonic dysfunction of the pelvic floor musculature (PFM). The literature on the subject is not conclusive about the diagnostic potential of surface electromyography (sEMG), which could be due to poor signal characterization. In this study, we characterized the PFM activity of three groups of 24 subjects each: CPP patients with deep dyspareunia associated with a myofascial syndrome (CPP group), healthy women over 35 and/or parous (>35/P group, i.e., CPP counterparts) and under 35 and nulliparous (<35&NP). sEMG signals of the right and left PFM were recorded during contractions and relaxations. The signals were characterized by their root mean square (RMS), median frequency (MDF), Dimitrov index (DI), sample entropy (SampEn), and cross-correlation (CC). The PFM activity showed a higher power (>RMS), a predominance of low-frequency components (DI), greater complexity (>SampEn) and lower synchronization on the same side (35/P group. The same trend in differences was found between healthy women (<35&NP vs. >35/P) associated with aging and parity. These results show that sEMG can reveal alterations in PFM electrophysiology and provide clinicians with objective information for CPP diagnosis.

Effect of BoNT/A in the Surface Electromyographic Characteristics of the Pelvic Floor Muscles for the Treatment of Chronic Pelvic Pain.

Chronic pelvic pain (CPP) is a complex condition with a high economic and social burden. Although it is usually treated with botulinum neurotoxin type A (BoNT/A) injected into the pelvic floor muscles (PFM), its effect on their electrophysiological condition is unknown. In this study, 24 CPP patients were treated with BoNT/A. Surface electromyographic signals (sEMG) were recorded at Weeks 0 (infiltration), 8, 12 and 24 from the infiltrated, non-infiltrated, upper and lower PFM. The sEMG of 24 healthy women was also recorded for comparison. Four parameters were computed: root mean square (RMS), median frequency (MDF), Dimitrov's index (DI) and sample entropy (SampEn). An index of pelvic electrophysiological impairment (IPEI) was also defined with respect to the healthy condition. Before treatment, the CPP and healthy parameters of almost all PFM sides were significantly different. Post-treatment, there was a significant reduction in power (MDF), lower fatigue index (SampEn) in all sites in patients, mainly during PFM contractions, which brought their electrophysiological condition closer to that of healthy women (

Clinical pilot study to evaluate the neovaginal PACIENA prosthesis® for vaginoplasty without skin grafts in women with vaginal agenesis.

BACKGROUND: To evaluate the feasibility and clinical outcomes of vaginoplasties using a neovaginal polylactic acid prosthesis made with 3-dimensional (3D) printing technology as an intraneovaginal mould. METHODS: This was an interventionist, prospective, and multicentre clinical pilot investigation of a sanitary product (PACIENA prosthesis®) aiming to recruit and operate on 8 patients over 6 months with a follow-up period of 6 months. Only six patients with Rokitansky syndrome and one patient with Morris syndrome (7 patients in total) were operated on in two university hospitals: "La Fe", Valencia (H1) and "Arrixaca", Murcia (H2). INTERVENTIONS: Extensive surgical dissection of a defined space between the urethra and bladder in the front and of the rectum in the back as well as insertion of the PACIENA prosthesis® covered with Interceed® were performed. After 12 days, the prosthesis was changed to the silicone-covered version for daily application. RESULTS: In the 6 patients with Rokitansky syndrome (86%), the primary endpoint (satisfactory vaginal outcome in terms of appearance, function, and sensation without relevant additional morbidity) was achieved, although only 2 patients (28%) were sexually active at the end of 6 months of follow-up. The patient with Morris syndrome withdrew from the study after 1 month. Patients without bacterial colonization showed positive Schiller tests at 1 month, and subsequent biopsies showed adequate keratinization and epidermization. Epithelization and iodopositivity were delayed in the patients who developed inflammatory granulomas. CONCLUSIONS: Good anatomical and functional results can be achieved with the PACIENA prosthesis® for vaginoplasties without skin grafts. However, adequate patient selection and education, good surgical techniques and haemostasis, postoperative support, and prevention of bacterial colonization are important. TRIAL REGISTRATION: This clinical study was approved by the Ethical Clinical Investigation Committee of San Juan University Hospital on September 27, 2016, to be conducted in the participating centres; it was authorized by the Spanish Agency of Medicines and Health Products (AEMPS) on April 24, 2017 (exp. no. 585/16/EC), to be carried out in that hospitals.

Treatment of Vestibulodynia with Submucosal Injections of IncobotulinumtoxinA into Targeted Painful Points: An Open-Label Exploratory Study.

The studies carried out to date on vulvodynia treatment with botulinum neurotoxin type A (BoNT/A) have followed generic injection protocols and reported contradictory outcomes on its effects. The aim of the present study was thus to propose a protocol for injecting BoNT/A into targeted painful points, to comprehensively assess the clinical effect of BoNT/A treatment and identify the risk/protective factors for successful treatment. Thirty-five vestibulodynia patients were treated with submucosal injections of incobotulinumtoxinA and assessed 8, 12 and 24 weeks after their treatment. Their clinical and pelvic statuses were assessed from self-reported questionnaires (Visual Analogue Scale (VAS), Female Sexual Function Index (FSFI), Marinoff's Dyspareunia Scale (MDS), Hospital Anxiety and Depression Scale (HADS), Catastrophizing Scale (CS)), physical examinations and surface electromyography (sEMG). The patients reported a reduction in provoked vestibulodynia (FSFI, p < 0.01;

Changes in pelvic floor electrical activity and vulvar pain after botulinum toxin treatment of vestibulodynia: are clinical and electrophysiological outcomes related?

Vestibulodynia is a gynecological condition with different treatment options available, including botulinum neurotoxin type A (BoNT/A) injections into the vulvar vestibule. Unlike other treatments, no studies have assessed changes in the myoelectrical activity of the pelvic floor muscles (PFM) after BoNT/A treatment. The aim of this study was thus to evaluate these changes and to correlate them with changes in vulvar pain sensitivity. To do this, 35 patients with vestibulodynia were recruited, the myoelectrical activity of their left and right PFM was recorded with surface electromyography (sEMG), and their vulvar pain sensitivity was monitored according to Visual Analogue Scale (VAS) and an algometer, both before and after BoNT/A treatment. According to our results, patients' signals during PFM relaxation showed a significantly higher power than those of healthy women at baseline, as shown by their root mean square values (RMS), but became similar at follow-up. Patients' mean vulvar pain VAS scores significantly decreased after treatment. Furthermore, baseline-to-follow-up differences of RMS at PFM rest vs. mean VAS were significantly correlated (CC=0.48, p<0.01) so that higher reductions in the PFM activity power were associated with higher decreases in vulvar pain.Clinical Relevance- Altered PFM electrophysiological condition of patients with vestibulodynia becomes similar to healthy women's after BoNT/A treatment. This study also points to a relationship between the evolution of clinical and PFM electrophysiological conditions.

Treatment of Dyspareunia with Botulinum Neurotoxin Type A: Clinical Improvement and Influence of Patients' Characteristics.

The treatment of chronic pelvic pain (CPP) with botulinum neurotoxin type A (BoNT/A) has increased lately, but more studies assessing its effect are needed. This study aimed to evaluate the evolution of patients after BoNT/A infiltration and identify potential responders to treatment. Twenty-four women with CPP associated with dyspareunia were treated with 90 units of BoNT/A injected into their pelvic floor muscle (PFM). Clinical status and PFM activity were monitored in a previous visit (PV) and 12 and 24 weeks after the infiltration (W12, W24) by validated clinical questionnaires and surface electromyography (sEMG). The influence of patients' characteristics on the reduction in pain at W12 and W24 was also assessed. After treatment, pain scores and the impact of symptoms on quality of life dropped significantly, sexual function improved and sEMG signal amplitude decreased on both sides of the PFM with no adverse events. Headaches and bilateral pelvic pain were risk factors for a smaller pain improvement at W24, while lower back pain was a protective factor. Apart from reporting a significant clinical improvement of patients with CPP associated with dyspareunia after BoNT/A infiltration, this study shows that clinical characteristics should be analyzed in detail to identify potential responders to treatment.