New TENSI+ Device for Transcutaneous Posterior Tibial Nerve Stimulation: A Prospective, Multicentre, Post-market Clinical Study.

BACKGROUND AND OBJECTIVE: Our aim was to report the first clinical trial of TENSI+, a new device for transcutaneous posterior tibial nerve stimulation (TNS) for treatment of overactive bladder (OAB). METHODS: A prospective, multicentre clinical trial was conducted in adults with OAB in seven French centres. The main exclusion criteria were prior percutaneous or transcutaneous TNS or invasive OAB treatment, current antimuscarinic use, 24-h polyuria, known bladder disease, postvoid residual volume >150 ml, and pelvic organ prolapse stage >2. Patients self-administered daily TTNS sessions of 20 min with TENSI+ at home after education by a specialized nurse. A bladder diary, Urinary Symptom Profile and OAB-q questionnaires, and Patient Global Impression of Improvement (PGI-I) scores were evaluated at baseline and 3 and 6 mo. The primary endpoint was efficacy, based on PGI-I and variations in bladder diary parameters. Success was defined as a PGI-I score ≤3 and any improvement ≥30% in bladder diary parameters. KEY FINDINGS AND LIMITATIONS: The study included 78 patients (13 males). Nine patients had neurological disease, 21 had previously tried antimuscarinics, and 41 had wet OAB at baseline. At 3 mo, 65/78 patients had a full analysis set. Treatment was successful in 44/65 patients (67%), with 25/65 (38%) reporting both an objective improvement and high satisfaction. All OAB-related endpoints were significantly improved, except bladder capacity and total voided volume per 24 h. At 6 mo, only five of 44 patients had interrupted their treatment. No factor predictive of success was identified. Two adverse events (pain at stimulation site and/or pelvic pain) were reported and spontaneously resolved without treatment interruption. CONCLUSIONS AND CLINICAL IMPLICATIONS: TENSI+ is a safe and effective TTNS treatment option for OAB management. PATIENT SUMMARY: TENSI+ is a new device for nerve stimulation in patients with overactive bladder. Patients use the device at home every day. In our short-term trial, TENSI+ use improved symptoms in 67% of patients. Further evaluation over a longer period of time is needed.

Evolving types of pudendal neuromodulation for lower urinary tract dysfunction.

Introduction: Sacral neuromodulation and posterior tibial nerve stimulation for lower urinary tract dysfunction (LUTD) and overactive bladder yield good and reliable results. However, neuromodulation research is continuously evolving because there is still need for more patient-friendly treatment options in the therapeutic management of LUTD. Pudendal neuromodulation (PNM) has been emerging as a promising alternative treatment option for the last few decades. The aim of this study is to review the current state of the art of PNM. Material and methods: A wide literature search was conducted in the field of PNM using Medline through the PubMed database and Elsevier using the Scopus database; a critical review of the results was then carried out. PNM has been studied in its various possible aspects: percutaneous PNM, transrectal/transvaginal PNM, and both percutaneous and transcutaneous dorsal genital nerve stimulation. Results: Each technique was found to result in promising improvements in different clinical outcomes, with some trials reporting even better results than sacral neuromodulation. Conclusions: As a result of a comparison between the various PNM techniques with both sacral neuromodulation and posterior tibial nerve stimulation, we think that PNM should be seen as seriously promising, and we believe it will expand the treatment options for overactive bladder. Even though several studies accordingly showed PNM to be safe and effective, a systematic review and meta-analysis were not feasible. PNM in its various techniques is a promising treatment for LUTD. Nevertheless, further research is needed to include it in treatment algorithms.

Posterior Tibial Nerve Stimulation for the Treatment of Detrusor Overactivity in Multiple Sclerosis Patients: A Narrative Review.

Bladder dysfunction, particularly neurogenic detrusor overactivity (DO), poses a substantial challenge in multiple sclerosis (MS) patients, detrimentally impacting their quality of life (QoL). Conventional therapies often fall short, necessitating alternative approaches like posterior tibial nerve stimulation (PTNS) for effective management. This narrative review critically examines the application of PTNS in treating DO among MS patients, aiming to provide a comprehensive synthesis of its efficacy, underlying mechanisms, and clinical outcomes. By evaluating a spectrum of studies, including randomized controlled trials and long-term follow-up research, the review elucidates PTNS's role in enhancing bladder control and ameliorating symptoms of urgency and incontinence, thereby improving patient well-being. Despite its potential, the review acknowledges the limited scope of existing research specific to MS-induced neurogenic DO and calls for further investigation to optimize PTNS protocols and understand its long-term benefits. Highlighting PTNS's minimal invasiveness and favorable safety profile, the review advocates for its consideration as a viable third-line treatment option in MS-related bladder dysfunction management. Through this analysis, the review contributes to the broader narrative of seeking effective, patient-centered therapeutic strategies for MS-related complications, underscoring the importance of personalized care in improving patient outcomes.

Consenso Baiona sobre Incontinencia Fecal: Asociación Española de Coloproctología / Baiona's Consensus Statement for Fecal Incontinence. Spanish Association of Coloproctology

La incontinencia fecal (IF) constituye un importante problema sanitario, tanto a nivel individual como para los diferentes sistemas de salud, lo que origina una preocupación generalizada para su resolución o, al menos, disminuir en lo posible los numerosos efectos indeseables que provoca, al margen del elevado gasto que ocasiona. Existen diferentes criterios relacionados con las pruebas diagnósticas a realizar, y lo mismo acontece con relación al tratamiento más adecuado, dentro de las numerosas opciones que han proliferado durante los últimos años, no siempre basadas en una rigurosa evidencia científica. Por dicho motivo, desde la Asociación Española de Coloproctología (AECP) nos propusimos elaborar un Consenso que sirviese de orientación a todos los profesionales sanitarios interesados en el problema, conscientes, no obstante, de que la decisión terapéutica debe tomarse de manera individualizada: características del paciente/experiencia del terapeuta. Para su elaboración optamos por la técnica de grupo nominal. Los niveles de evidencia y los grados de recomendación se establecieron de acuerdo a los criterios del Oxford Centre for Evidence-Based Medicine. Por otra parte, en cada uno de los ítems analizados se añadieron, de forma breve, recomendaciones de los expertos.(AU)

Faecal incontinence (FI) is a major health problem, both for individuals and for health systems. It is obvious that, for all these reasons, there is widespread concern for healing it or, at least, reducing as far as possible its numerous undesirable effects, in addition to the high costs it entails. There are different criteria for the diagnostic tests to be carried out and the same applies to the most appropriate treatment, among the numerous options that have proliferated in recent years, not always based on rigorous scientific evidence. For this reason, the Spanish Association of Coloproctology (AECP) proposed to draw up a Consensus to serve as a guide for all health professionals interested in the problem, aware, however, that the therapeutic decision must be taken on an individual basis: patient characteristics/experience of the care team. For its development it was adopted the Nominal Group Technique methodology. The Levels of Evidence and Grades of Recommendation were established according to the criteria of the Oxford Centre for Evidence-Based Medicine. In addition, expert recommendations were added briefly to each of the items analysed.(AU)

Baiona's Consensus Statement for Fecal Incontinence. Spanish Association of Coloproctology.

Faecal incontinence (FI) is a major health problem, both for individuals and for health systems. It is obvious that, for all these reasons, there is widespread concern for healing it or, at least, reducing as far as possible its numerous undesirable effects, in addition to the high costs it entails. There are different criteria for the diagnostic tests to be carried out and the same applies to the most appropriate treatment, among the numerous options that have proliferated in recent years, not always based on rigorous scientific evidence. For this reason, the Spanish Association of Coloproctology (AECP) proposed to draw up a consensus to serve as a guide for all health professionals interested in the problem, aware, however, that the therapeutic decision must be taken on an individual basis: patient characteristics/experience of the care team. For its development it was adopted the Nominal Group Technique methodology. The Levels of Evidence and Grades of Recommendation were established according to the criteria of the Oxford Centre for Evidence-Based Medicine. In addition, expert recommendations were added briefly to each of the items analysed.

Long-Term Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in the Treatment of Functional Non-Retentive Fecal Incontinence in Children.

BACKGROUND: Functional non-retentive fecal incontinence (FNRFI) is a psychologically upsetting and embarrassing issue and affects children's quality of life negatively. AIM OF THIS STUDY: Evaluation of the short and long-term effect of Bilateral transcutaneous posterior tibial nerve stimulation (BTPTNS) in the treatment of FNRFI in children and its impact on the quality of life (QoL). Methodology: The current randomized controlled study included 94 Children with FNRFI who were randomly allocated into two equal groups. Group A received BTPTNS and Group B Received Sham BTPTNS. Follow-up was planned for 24 months for manometric findings, incontinence score, Incontinence episodes, and the QoL. RESULTS: The incontinence score was significantly decreases in Group A more than what was reported in Group B at 6, 12, 24 months follow up . In group A 53.2% of the included children who received BTPTNS showed a decrease in the incontinence episodes more than 75% and among them, 23.4% were fully continent. All the QoL domains were significantly improved in Group A after 6, 12, and 24 months when compared with Group B. CONCLUSION: BTPTNS can be a good modality in the treatment of FNRFI with favorable long-term maintenance of its effect together with a remarkable positive impact on all domains of QoL.

Neuromodulation for the management of chronic pelvic pain syndromes: A systematic review.

BACKGROUND: Chronic pelvic pain is a burdensome condition that involves multiple medical sub-specialties and is often difficult to treat. Sacral stimulation for functional bladder disease has been well established, but little large-scale evidence exists regarding utilization of other neuromodulation techniques to treat chronic pelvic pain. Emerging evidence does suggest that neuromodulation is a promising treatment, and we aim to characterize the use and efficacy of such techniques for treating chronic pelvic pain syndromes. MATERIALS AND METHODS: A systematic review of the literature demonstrating the treatment of chronic pelvic pain syndromes with neuromodulation. Abstracts were reviewed and selected for inclusion, including case series, prospective studies, and randomized controlled trials (RCTs). Case studies and publications in abstract only were not included. The reporting for this systematic review follows Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA). The literature search was performed using MEDLINE, Embase, Cochrane Library, PubMed, CINAHL, and Scopus. RESULTS: A total of 50 studies were included in this review, three of which were randomized controlled trials, and the remaining were prospective and retrospective case series. The range of pelvic pain conditions treated included interstitial cystitis, peripheral neuralgia, pudendal neuralgia, gastrointestinal pain, urogenital pain, sacroiliac joint pain, and visceral chronic pelvic pain. We reported on outcomes involving pain, functionality, psychosocial improvement, and medication reduction. CONCLUSIONS: Neuromodulation is a growing treatment for various chronic pain syndromes. Peripheral nerve stimulation was the least studied form of stimulation. Posterior tibial nerve stimulation appears to offer short-term benefit, but long-term results are challenging. Sacral nerve stimulation is established for use in functional bladder syndromes and appears to offer pain improvement in these patients as well. Dorsal root ganglion stimulation and spinal cord stimulation have been used for a variety of conditions with promising results. Further studies of homogeneous patient populations are necessary before strong recommendations can be made at this time, although pooled analysis may also be impactful.

Long-Term Cost Analysis of Third-Line Treatment Options for Overactive Bladder.

INTRODUCTION: We aimed to analyze the long-term cost of overactive bladder third-line treatments. METHODS: This insurance claims review analyzed the 2015 to 2020 MarketScan (MKS) claims data set subjects age ≥ 18, diagnosis of overactive bladder (OAB) using ICD-9/ICD-10 codes and receipt of treatment for percutaneous tibial nerve stimulation, sacral neuromodulation (SNM), or botulinum A. Age, gender, treatment types, and cost were extracted. Treatment costs were aggregated at the level of patient and treatment type for total payment and patient contribution by combining copay, coinsurance, and deductible. We used the Wilcoxon rank-sum test for continuous and chi-square test for categorical variables. SAS v9.4 was used for analyses. Significance was set at P < .05. RESULTS: We identified 17,755 patients from the commercial claims MKS and 10,912 patients from the Medicare supplemental (MDC) database with mean age 50.7±11.1 and 75.5±7.6 years, respectively, who underwent ≥ 1 third-line OAB treatment. Patients receiving third-line treatment were predominantly female (84.9%, MKS, 74.8%, MDC). Long-term costs over a 15-year period were estimated. Percutaneous tibial nerve stimulation is the most expensive in terms of total net payment ($105,337.50 MKS, $94,102.50 MDC) and patient contribution ($9177.60 MKS, $3921.00 MDC). Total net payment for botulinum A was $67,968 (MSK), $54,261 (MDC), and patient contribution cost was $2850 (MSK), $1110 (MDC). The most cost-effective option was SNM in terms of both total net payment ($5179.10 MKS, $6099.00 MDC) and patient contribution ($59.10 MKS, $60.00 MDC). CONCLUSIONS: SNM was the most cost-effective third-line treatment for OAB looking over a 15-year period in terms of both total net payment and patient contribution.

Device evaluation: eCoin #x2013; implantable tibial nerve stimulator for overactive bladder.

INTRODUCTION: Peripheral nerve stimulation has been demonstrated as a viable alternative to sacral nerve stimulation in managing refractory overactive bladder (OAB). New technologies allow the internalization of tibial nerve stimulators through various apparatuses. One such device, the eCoin, is a small, coin-shaped device that can be implanted adjacent to the tibial nerve that provides pre-programmed stimulation. AREAS COVERED: We will review the literature on eCoin implantation, from proof of concept to mid-term data, with the longest period of follow-up being 12 months. All studies on this technology will be reviewed, along with an analysis of the current state of play in implantable neuromodulators for overactive bladder. Efficacy, durability, adverse events, and viability of eCoin as a long-term management option will be considered. EXPERT OPINION: The eCoin device demonstrates promising early data for efficacy in managing overactive bladder symptoms. Complication rates remain low and are mostly related to wound healing following the initial placement of the device. Research into the continued improvement and modification of the device appears optimistic, but longer-term data still need to be obtained. Indeed, implantable PTNS have a role in the future management of overactive bladder, and devices such as eCoin will still need to prove a long-term benefit to be a mainstay of management.

Transcutaneous Tibial Nerve Stimulation for Primary Dysmenorrhea: A Protocol for a Randomized Controlled Trial.

Primary dysmenorrhea (PD) is a painful menstruation that can persist for the duration of a woman's fertile life. Non-steroidal anti-inflammatory drugs, hormonal therapy, physiotherapy techniques, etc., are the main treatments. The main objective of this study is to evaluate the effectiveness of transcutaneous posterior tibial nerve stimulation (TTNS) in PD patients. The study will consist of a single-blind randomized clinical trial, parallel-assigned with two arms. Women with PD (18-43 years) with regular menstrual cycles and at least 4 points in VAS will be randomly divided into experimental (TTNS) and placebo (simulated stimulation) groups during 12 treatment sessions (1 session/week) and several follow-ups: monthly during treatment and 1, 3 and 6 months after. Maximum and mean pain intensity, pain duration, pain severity, number of anti-inflammatory drugs, quality of life, sleep quality, overall improvement, treatment satisfaction and secondary effects will be measured once a month every 6 months and at 3 and 6 months. The Student's t-test for independent samples or the Mann-Whitney U test will be used. The literature shows effective physiotherapeutic techniques for PD in the short term, which do not act on causes and have limitations. The TTNS technique can be used in transcutaneous and percutaneous modalities, with similar effectiveness, but the transcutaneous causes less discomfort. TTNS modulates pain, and long-term benefits could be achieved at low cost and without patient discomfort.

Posterior tibial nerve stimulation as a neuromodulation therapy in treatment of neurogenic overactive bladder in multiple sclerosis: A prospective randomized controlled study.

BACKGROUND: one of the major annoying disorders occurring in people with multiple sclerosis is lower urinary tract disorders (LUT). Urgency is considered the main one seriously influencing the quality of life. Neurogenic detrusor over activity (DOAB) is characterized by a hyperreflexic, overactive detrusor that responds quickly to low-intensity sensory input from general visceral afferent fibers. Overactivity has been claimed to induce random, uncontrolled contractions of the detrusor muscle, leading to intravesicular pressure rise, producing urgency, frequency, and consequently incontinence AIM: To demonstrate the therapeutic efficacy for posterior tibial nerve stimulation (PTNS) in neurogenic over active bladder (NOAB) in people with multiple sclerosis METHODS: The current trial is a prospective, randomized controlled study. Forty remitting relapsing males with MS with moderate NOAB symptoms were randomly assigned into two equal groups; control group (C) treated by selected therapeutic exercises program for strengthening pelvic floor muscles and an intervention group (ES) receiving an additional posterior tibial nerve electrical stimulation. Each session ranged from 45- 50 minutes, three days weekly for a month. Outcome measures were recorded before starting the treatment and after termination of the study intervention and included over active bladder symptoms score (OVBS) score, urodynamic parameters (uroflow, filling and voiding cystometry), and post voiding residual volume by abdominal ultrasound RESULTS: There was a significant improvement of all voiding parameters compared to baseline and the group C except frequency of urgency incontinence. A significant decrease was detected in post-treatment mean episodes number of nighttime frequency, urgency, urgency incontinence (1.65 ± 0.93, 1.2 ± 0.52 and 1.5 ± 0.76) respectively of the ES group compared to that of group C (3.05 ± 1.09, 2.25 ± 0.71 and 2.25 ± 1.06) (P < 0.01). There was a significant decrease in median post-treatment OVBS score 3 (3-3) compared to group C median score 5 (6-4). A statistically significant improvement was observed of all urodynamic parameters (bladder capacity and compliance, Detrusor overactivity (DO), maximum flow rate and post voidal residual volume in the ES group compared to the group C CONCLUSION: PTNS is a promising and potentially beneficial treatment option for NOAB symptoms in males with MS and superior to pelvic floor muscle training alone.

Comparison of the efficacy and safety of sacral root magnetic stimulation with transcutaneous posterior tibial nerve stimulation in the treatment of neurogenic detrusor overactivity: an exploratory randomized controlled trial.

Background: Both repetitive sacral root magnetic stimulation (rSMS) and transcutaneous posterior tibial nerve stimulation (TTNS) have demonstrated clinical benefits for lower urinary tract dysfunction. However it still remains unclear that which method is more effective and safer to treat neurogenic detrusor overactivity (NDO). Methods: From December 2020 to December 2021, 50 patients (31 men and 19 women, aged 47.9±12.4 years) with NDO secondary to suprasacral spinal cord injury (SCI) were enrolled and randomly allocated to the rSMS or TTNS group based on a computer-generated random numbers table. The stimulation was applied continuously 5 times per week for 20 sessions. Urodynamic test was conducted at baseline and the day after the final 20th treatment session. The primary outcome was the individual change (Δ) in maximum cystometric capacity (MCC) from baseline to post-treatment. Secondary outcomes included changes (Δ) for the following parameters: volume at 1st involuntary detrusor contraction (1st IDCV), maximal detrusor pressure (Pdetmax), bladder compliance (BC), postvoid residual (PVR) volume, and bladder voiding efficiency (BVE). Additionally, adverse reactions including pain and skin irritation during stimulation were observed and recorded as safety outcomes. Results: Finally 47 patients completed the study (23 in rSMS and 24 in TTNS group). A per-protocol (PP) analysis was performed, and Mann-Whitney U test and unpaired t-test were used for statistical analysis. Compared with the efficacy of TTNS, rSMS showed statistically greater ΔMCC [median +43 mL (IQR, 22-62 mL) vs. +20 mL (IQR, 15-25 mL), P=0.001, with a between-group difference of +22 mL (95% CI: +7 to +35 mL)] and ΔBVE [median +10.0% (IQR, 3.8-15.7%) vs. +3.5% (IQR, 0.0-7.8%), P=0.003, with a between-group difference of +5.9% (95% CI: +1.2% to +9.7%)]. No significant differences were found in Δ1st IDCV (P=0.40), ΔPdetmax (P=0.67), ΔBC (P=0.79) and ΔPVR (P=0.92) between the two groups. Meanwhile, patients exhibited high tolerance to both protocols, and no adverse reactions were observed. Conclusions: RSMS may be more effective to improve urodynamics in the treatment for NDO than TTNS, cause it led to a statistical improvement in bladder capacity and voiding efficiency, without any side effects. RSMS is thus worthy of further clinical promotion. Trial Registration: Chinese Clinical Trial Registry ChiCTR2100050663.

Multimodal Management of Fecal Incontinence Focused on Sphincteroplasty: Long-Term Outcomes from a Single Center Case Series.

The management of patients with fecal incontinence and an external anal sphincter (EAS) defect remains controversial. A retrospective series of overlapping anal sphincteroplasties performed between 1985−2013 from a single center, supplemented by selective puborectalis plication and internal anal sphincter repair is presented. Patients were clinically followed along with anorectal manometry, continence scoring (Cleveland Clinic Incontinence Score­CCS) and patient satisfaction scales. Patients with a suboptimal outcome were managed with combinations of biofeedback therapy (BFT), peripheral tibial nerve stimulation (PTNS), sacral nerve stimulation (SNS) or repeat sphincteroplasty. There were 120 anterior sphincter repairs with 90 (75%) levatorplasties and 84 (70%) IAS repairs. Over a median follow-up of 120 months (IQR 60−173.7 months) there were significant improvements in the recorded CCIS values (90.8% with a preoperative CCIS > 15 vs. 2.5% postoperatively; p < 0.001). There were 42 patients who required ancillary treatment with four repeat sphincteroplasties, 35 patients undergoing biofeedback therapy, 10 patients treated with PTNS and three managed with SNS implants with an ultimate good functional outcome in 92.9% of cases. No difference was noted in ultimate functional outcome between those treated with sphincteroplasty alone compared with those who needed ancillary treatments (97.1% vs. 85.7%, respectively). Overall, 93.3% considered the outcome as either good or excellent. Long-term functional outcomes of an overlapping sphincteroplasty are good. If the initial outcome is suboptimal, response to ancillary treatments remains good and patients are not compromised by a first-up uncomplicated sphincter repair.

Posterior tibial nerve stimulation improves neurogenic bladder in rats with spinal cord injury through transient receptor potential/P2X signaling pathway.

BACKGROUND: To study the influences of posterior tibial nerve stimulation (PTNS) on neurogenic bladder and the expression of transient receptor potential (TRP) channels and P2X receptors in rats with spinal cord injury (SCI) and explore the possible mechanism. METHODS: SCI model was established by modified Allen's method and PTNS was performed. Urodynamic indexes and Haematoxylin and Eosine staining of bladder tissue were used to evaluate the therapeutic effect. The expression of TRP channels and P2X receptors in the bladder and dorsal root ganglia (DRG) was detected by real-time PCR and Western blot. RESULTS: The low compliance of bladder in treatment group was significantly improved compared with SCI group, and the infiltration of inflammatory cells in bladder tissue was significantly reduced. At the same time, the expression of TRP and P2X in bladder and DRG was partially restored after the treatment of PTNS. CONCLUSIONS: PTNS is an effective therapy for SCI-induced neurogenic bladder via the TRP/P2X signaling pathway.

Overactive bladder: A review and update.

Overactive bladder syndrome is a chronic, disabling condition with physical, psychological and social consequences that significantly affects the quality of life of millions of patients worldwide. The economic impact of this disorder is crucial. Overactive bladder syndrome is a little-known condition, with different manifestations from patient to patient, which causes a great deal of frustration to the medical staff involved. The patient requires a clear explanation and the full support of the attending physician. It is extremely important to establish a correct diagnosis and an effective individualized treatment. The collaboration and understanding of these patients are extremely important aspects. Improving the quality of life in these patients is the main purpose in managing this condition. There are several treatment modalities that may be used progressively, with favorable albeit inconsistent results. This condition remains extremely challenging for specialists and, unfortunately, always one of maximum interest.

Importancia de algunos aspectos técnicos del procedimiento de estimulación percutánea del nervio tibial posterior en pacientes con incontinencia fecal / Importance of some technical aspects of the procedure of percutaneous posterior tibial nerve stimulation in patients with fecal incontinence

Introducción: Los resultados de la estimulación percutánea del nervio tibial posterior (PTNS) en el tratamiento de la incontinencia fecal (IF) parecen discretos. El objetivo del estudio es valorar la relación de algunos aspectos técnicos con la respuesta clínica: localización del nervio, respuesta distal (motora o sensitiva) y acomodación. Métodos: Estudio prospectivo de pacientes con IF sometidos a terapia de PTNS. La repuesta clínica se valoró mediante la escala de Wexner, diario defecatorio y manometría anorrectal. Resultados: Se estudiaron 32 pacientes. La intensidad de localización (cercanía al nervio) no se correlacionó con cambios clínicos ni manométricos. La respuesta motora se relacionó con un descenso en la escala de Wexner [12,12 (± 5,39) a 7,71 (± 4,57) p < 0,005], el número de episodios de incontinencia pasiva [8,78 (± 9,64) a 4,11 (± 7,11) p = 0,025], el número total de episodios de incontinencia [16,11 (± 16,03) a 7,78 (± 11,34) p = 0,009] y el número de días con ensuciamiento fecal [6,89 (± 5,53) a 2,56 (± 4,13) p = 0,002] y con un aumento de la longitud del conducto anal manométrico en reposo [4,55 (± 0,596) a 4,95 (± 0,213) p = 0,004]. El incremento de estimulación (acomodación) se correlacionó de forma inversa con la disminución en la escala de Wexner (r = -0,677 p < 0,005) y el número de días con ensuciamiento (r = -0,650 p = 0,022). Conclusiones: La respuesta motora durante la PTNS parece relacionarse con una mejor respuesta clínica. El fenómeno de acomodación podría asociarse con peores resultados. La cercanía del electrodo al nervio no parece tener trascendencia, siempre que se consiga una buena respuesta distal. (AU)

Introduction: The results of percutaneous posterior tibial nerve stimulation (PTNS) in the treatment of fecal incontinence (IF) are modest. The aim of the study is to assess the relationship of some technical aspects with the clinical response: location of the nerve, distal response (motor or sensory) and accommodation. Methods: Prospective study of patients with FI undergoing PTNS therapy. The clinical response was assessed using the Wexner scale, defecation diary and anorectal manometry. Results: 32 patients were studied. The intensity of localization (proximity to the nerve) was not correlated with clinical or manometric changes. Motor response was associated with a decrease on the Wexner scale [12.12 (± 5.39) to 7.71 (± 4.57) p < 0.005], the number of episodes of passive incontinence [8.78 (± 9.64) to 4.11 (± 7.11) p = 0.025], the total number of incontinence episodes [16.11 (± 16.03) to 7.78 (± 11.34) p = 0.009] and the number of days with faecal soiling [6.89 (± 5.53) to 2.56 (± 4.13) p = 0.002] and with an increase in the length of the manometric anal canal at rest [4.55 (± 0.596) to 4.95 (± 0.213) p = 0.004]. The increase in stimulation (accommodation) was inversely correlated with the decrease in the Wexner scale (r = -0.677 p < 0.005) and the number of days with soiling (r = -0.650 p = 0.022). Conclusions: The motor response during PTNS seems to be related to a better clinical response. The accommodation phenomenon could be associated with worse results. The proximity of the electrode to the nerve does not seem to be important as long as a good distal response is achieved. (AU)

First-line treatment posterior tibial nerve stimulation in patients with interstitial cystitis/bladder pain syndrome.

INTRODUCTION: The aim of this study was to determine the effects of first-line treatment posterior tibial nerve stimulation (PTNS), applied once a week for a 12 week period, as a treatment modality for patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). MATERIAL AND METHODS: A total of 39 female patients with IC/BPS were enrolled in the study. Patients had one 30-minute session of PTNS per week for 12 weeks and symptoms were assessed before and after the treatment sessions by the use of a voiding diary, visual analog scale (VAS) for pain, O'Leary-Sant interstitial cystitis symptom index (ICSI), and O'Leary-Sant interstitial cystitis problem index (ICPI). RESULTS: The mean age of the patients was 38.9 ±7.1 years. The improvements in voiding diary parameters after 12 weeks of PTNS treatment were statistically significant compared to baseline but the changes in nocturia, and average voiding volume were not statistically significant. Mean parametric improvements after 12 weeks of PTNS treatment compared to baseline included a daytime frequency decrease by 3.8 voids daily, urgency episodes decrease by 4.7 episodes daily, nocturia decrease by 0.3 voids and voided volume improvement by a mean of 8.4 ml. The difference for ICSI, ICPI and VAS between baseline and the 12th week of PTNS treatment scores demonstrated statistically significant improvements in pain severity, symptom and problem index. CONCLUSIONS: The findings in this study demonstrated the improvements of voiding diaries, ICSI, ICPI and VAS scores in patients with IC/BPS after 12 weeks PTNS. PTNS treatment is a beneficial firs-line treatment option to IC/BPS symptom amelioration.

Importance of some technical aspects of the procedure of percutaneous posterior tibial nerve stimulation in patients with fecal incontinence.

INTRODUCTION: The results of percutaneous posterior tibial nerve stimulation (PTNS) in the treatment of fecal incontinence (IF) are modest. The aim of the study is to assess the relationship of some technical aspects with the clinical response: location of the nerve, distal response (motor or sensory) and accommodation. METHODS: Prospective study of patients with FI undergoing PTNS therapy. The clinical response was assessed using the Wexner scale, defecation diary and anorectal manometry. RESULTS: 32 patients were studied. The intensity of localization (proximity to the nerve) was not correlated with clinical or manometric changes. Motor response was associated with a decrease on the Wexner scale [12.12 (±5.39) to 7.71 (±4.57) P < .005], the number of episodes of passive incontinence [8.78 (±9.64) to 4.11 (±7.11) P = .025], the total number of incontinence episodes [16.11 (±16.03) to 7.78 (±11.34) P = .009] and the number of days with fecal soiling [6.89 (±5.53) to 2.56 (±4.13) P = .002] and with an increase in the length of the manometric anal canal at rest [4.55 (±0.596) to 4.95 (±0.213) P = .004]. The increase in stimulation (accommodation) was inversely correlated with the decrease in the Wexner scale (r = -0.677 P < .005) and the number of days with soiling (r = -0.650 P = .022). CONCLUSIONS: The motor response during PTNS seems to be related to a better clinical response. The accommodation phenomenon could be associated with worse results. The proximity of the electrode to the nerve does not seem to be important as long as a good distal response is achieved.

Neuromodulación periférica en el síndrome de vejiga hiperactiva en mujeres: una revisión sistemática / Peripheral neuromodulation in women with overactive bladder syndrome: a systematic review

Introducción: El síndrome de vejiga hiperactiva (VH) es una disfunción urológica caracterizada por urgencia miccional, aumento de la frecuencia de las micciones, nicturia y puede llevar asociado incontinencia urinaria de urgencia. Dentro de las técnicas de tratamiento, la neuromodulación periférica del nervio tibial posterior (NMTP) está reconocida internacionalmente como una de las vías de abordaje, aunque no se ha probado un protocolo óptimo. El objetivo de esta revisión es conocer la evidencia disponible sobre cuál es el protocolo de la técnica de NMTP más empleado en la obtención de buenos resultados en el tratamiento de VH en mujeres.Adquisición de la evidenciaSe llevó a cabo una revisión sistemática de la literatura científica en las bases de datos Pubmed, Embase, WOS y Scopus. Se obtuvieron 222 resultados, con 58 duplicados, de los cuales 8 estudios cumplieron los criterios de inclusión establecidos, todos ellos ensayos clínicos aleatorizados.Síntesis de la evidenciaLa técnica de NMTP más utilizada en los trabajos incluidos que muestran estos resultados beneficiosos en mujeres con VH es la percutánea con una aguja colocada 5-6cm en posición proximal al maléolo tibial, por detrás del borde de la tibia y con los parámetros de 200μs de duración de impulso, 20Hz de frecuencia, 30 minutos de tiempo por sesión y con una frecuencia que podría ser de una sesión por semana durante 12 semanas.ConclusiónLa NMTP puede tener efectos beneficiosos y seguros a corto plazo en la VH en mujeres. A pesar de mostrar mejorías estadísticamente significativas en los síntomas clínicos, son necesarias más investigaciones para poder obtener evidencias científicas claras sobre el tipo de protocolo óptimo para el tratamiento de la VH en mujeres. (AU)

Introduction: Overactive bladder syndrome (OBS) is a urological disorder characterized by urinary urgency, increased frequency, nocturia, and may be associated with urge urinary incontinence. Posterior tibial nerve peripheral neuromodulation (PTNS) is globally recognized within the treatment options available, although an optimal protocol has not been tested. The objective of this review is to collect the evidence available on the most widely used protocol of the PTNS technique in obtaining good results in the treatment for women with OBS.Evidence acquisitionA systematic review of the scientific literature was carried out in PubMed, Embase, WoS and Scopus databases. A total of 222 results were obtained, with 58 duplicates, of which 8 studies met the established inclusion criteria, all of them randomized clinical trials.Evidence synthesisThe included works show that the most widely used PTNS technique with beneficial results in women with OBS is the percutaneous route with a needle placed 5-6cm proximal to the tibial malleolus, posterior to the edge of the tibia, with the following parameters: 1 weekly session of 30minutes duration for 12 weeks, the use of pulse widths of 200μs with frequency of 20Hz.ConclusionPTNS may have beneficial and safe short-term effects in women with OBS. Despite showing statistically significant improvements in clinical symptoms, further research is needed to obtain clear scientific evidence on the optimal protocol for treating women with OBS. (AU)

Randomized clinical trials assessing third-line therapies to treat non-neurogenic overactive bladder syndrome: a review about methodology.

INTRODUCTION AND HYPOTHESIS: Using similar methodologies and outcome measures is crucial to allow pertinent literature reviews and meta-analyses. Therefore, this scoping review aims to compare methodologies of randomized clinical trials (RCTs) assessing the efficacy of third-line therapies to treat non-neurogenic OAB: intradetrusor onabotulinumtoxinA (BoNTA) injections, sacral neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS). METHODS: A literature search was conducted using the PubMed search database. Using filters, the search was limited to RCTs conducted on humans and written in English or French since 2000 which evaluated BoNTA injections, SNM and/or PTNS. RCTs focusing on pediatric or neurogenic OAB were excluded. For each included RCT, methodology was assessed using a standardized form investigating the study design, clinical outcomes and urodynamic outcomes. Inclusion criteria, sex ratio, blinding strategies, treatment arms, primary outcomes and delays for reevaluation were assessed. Availability of clinical and urodynamic outcomes was reported at baseline, 3 months and 6 months. RESULTS: Thirty-one RCTs were included in the final synthesis. The most frequent main outcome measure was change in the number of urinary incontinence episodes in 35.5% and in the number of voids per day in 25.8%. Bladder diaries were lacking in 12.9%, 32.3% and 80.1% at baseline, 3 and 6 months, respectively, while 26% of studies reported the results of urodynamic studies at any point. CONCLUSION: Heterogeneity in study designs and data collection was pointed out between RCTs assessing the efficacy of third-line therapies to treat non-neurogenic OAB. We therefore advocate for the development of specific research guidelines focusing on OAB-related therapies.