ABSTRACT
OBJECTIVE: To evaluate the clinical efficacy of long-term spinal and sacral programmable neurostimulation for pelvic organ dysfunction in patients with myelodysplasia and chronic dysfunction of the bladder and rectum. MATERIAL AND METHODS: A retrospective study included 32 children aged 1-17 years (mean 10.7) with myelodysplasia, pelvic organ dysfunction and ineffective therapy including botulinum therapy and exclusion of tethered spinal cord syndrome. All children underwent comprehensive urodynamic examination with analysis of bladder and residual urine volume, mean flow rate, intravesical pressure and total urine volume, as well as electromyographic examination. Examination was carried out before surgery, after 6, 12 and 36 months. We applied urinary diary, NBSS questionnaire and urodynamic examination data. All patients underwent neurological examinations (neurological status, magnetic resonance imaging of the spinal cord, computed tomography and radiography of the spine, electroneuromyography). The study was conducted at the neurosurgical department of the Republican Children's Clinical Hospital in Ufa between 2014 and 2022. There were 32 implantations of epidural neurostimulators for pelvic organ dysfunctions. RESULTS: Patients used epidural spinal and sacral stimulation up to 6 times a day for 10-15 min turning on the pulse generator. This method significantly increased urinary volume, decreased episodes of urinary leakage and fecal incontinence, residual volume after urination and number of periodic catheterizations compared to baseline data. Sixteen patients were very satisfied, 10 ones were moderately satisfied, and 2 patients were not satisfied with therapy. The number of bladder catheterizations per day decreased by 51.1%. Urine volume significantly increased from 131.5±16.1 to 236±16.7 ml, intravesical pressure decreased from 23.5±4.2 to 18.5±2.1 cm H2O (by 20.3%). CONCLUSION: Chronic epidural spinal and sacral stimulation can improve the quality of life in patients with pelvic organ dysfunction. This technique may be effective for pelvic organ dysfunction caused by myelodysplasia.
Subject(s)
Electric Stimulation Therapy , Urinary Bladder, Neurogenic , Child , Humans , Quality of Life , Retrospective Studies , Multiple Organ Failure/complications , Multiple Organ Failure/therapy , Urinary Bladder, Neurogenic/etiology , Urinary Bladder, Neurogenic/therapy , Sacrum/diagnostic imaging , Treatment Outcome , Electric Stimulation Therapy/adverse effects , Electric Stimulation Therapy/methodsABSTRACT
OBJECTIVES: Fluoroscopy has significantly improved lead placement and decreased surgical time for implantable sacral neuromodulation (SNM). There is a paucity of data regarding radiation and safety of fluoroscopy during SNM procedures. Our study aims to characterize fluoroscopy time and dose used during SNM surgery across multiple institutions and assess for predictors of increased fluoroscopy time and radiation dose. METHODS: Electronic medical records were queried for SNM procedures (Stage 1 and full implant) from 2016 to 2021 at four academic institutions. Demographic, clinical, and intraoperative data were collected, including fluoroscopy time and radiation dose in milligray (mGy). The data were entered into a centralized REDCap database. Univariate and multivariate analysis were performed to assess for predictive factors using STATA/BE 17.0. RESULTS: A total of 664 procedures were performed across four institutions. Of these, 363 (54.6%) procedures had complete fluoroscopy details recorded. Mean surgical time was 58.8 min. Of all procedures, 79.6% were performed by Female Pelvic Medicine and Reconstructive Surgery specialists. There was significant variability in fluoroscopy time and dose based on surgical specialty and institution. Most surgeons (76.4%) were considered "low volume" implanters. In a multivariate analysis, bilateral finder needle testing, surgical indication, surgeon volume, and institution significantly predicted increased fluoroscopy time and radiation dose (p < 0.05). CONCLUSIONS: There is significant variability in fluoroscopy time and radiation dose utilized during SNM procedures, with differences across institutions, surgeons, and subspecialties. Increased radiation exposure can have harmful impacts on the surgical team and patient. These findings demonstrate the need for standardized fluoroscopy use during SNM procedures.
Subject(s)
Electric Stimulation Therapy , Radiation Exposure , Surgeons , Urinary Bladder, Overactive , Humans , Female , Urinary Bladder, Overactive/therapy , Electric Stimulation Therapy/methods , Sacrum , Radiation Exposure/adverse effectsABSTRACT
OBJECTIVE: Sacral neuromodulation (SNM) has emerged as an effective therapy for refractory lower urinary tract dysfunction (LUTD). Remote programming holds promise in addressing the time and economic burdens associated with outpatient programming, especially for patients in the observation period following Stage I implant surgery (where the lead is implanted first without the pulse generator). The study aimed to explore the effectiveness and patient satisfaction of remote programming for Stage I SNM patients, and analyze the benefits patients gain from remote programming. METHODS: This prospective study was conducted at multiple high-level clinical SNM centres in China. Patients requiring SNM implantation were enroled and divided into two groups based on patient preference: remote programming (RP) group and outpatient control (OC) group. Patient attitudes toward RP were assessed through questionnaires, and the degree of symptom improvement was compared between the two groups to explore the usability of RP. RESULTS: A total of 63 participants from 6 centres were included in the study, with 32 belonging to the RP group. The remote programming system presents a high level of usability (98%) and willingness (satisfaction rate: 96.83%) in result of questionnaire. RP showed a significant advantage in improving patients' score of ICSI/ICPI (medianΔICSI/ICPI RP vs. OC= -13.50 vs -2, P =0.015). And slightly ameliorate urinary symptoms such as pain (medianΔVAS RP vs. OC= -1 vs 0, P = 0.164) and urgency (medianΔOBASS -2.5 vs. -1, P = 0.,229), but the difference was not statistically significant. RP did not significantly impact the quality of life of patients ( P =0.113), so do the rate of phase-two conversion ( P = 0.926) or programming parameters. CONCLUSION: To the best of our knowledge, the presented study is the first multicenter research focusing on the remote programming of Stage I SNM patients. Through the clinical implementation and patient feedback, we demonstrate that remote programming is not inferior to in-person programming in terms of success rate, effectiveness, safety, and patient satisfaction.
Subject(s)
Electric Stimulation Therapy , Feasibility Studies , Patient Satisfaction , Humans , Prospective Studies , Female , Male , Middle Aged , Adult , Electric Stimulation Therapy/methods , Electric Stimulation Therapy/instrumentation , Aged , Treatment Outcome , Surveys and Questionnaires , Lumbosacral Plexus , Lower Urinary Tract Symptoms/therapy , China , Sacrum/innervationABSTRACT
AIM: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). METHOD: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. RESULTS: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. CONCLUSION: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.
Subject(s)
Constipation , Cost-Benefit Analysis , Electric Stimulation Therapy , Humans , Constipation/therapy , Constipation/economics , Electric Stimulation Therapy/economics , Electric Stimulation Therapy/methods , Electric Stimulation Therapy/adverse effects , Treatment Outcome , Adult , Lumbosacral Plexus , Female , Child , Randomized Controlled Trials as Topic , Male , Sacrum/innervation , Middle Aged , Gastrointestinal TransitABSTRACT
INTRODUCTION: Staged sacral neuromodulation (SNM) testing has been shown to have a high rate of progression to permanent implantation for the management of voiding dysfunction. Stage 1 lead placement (SNM-I) can be performed under monitored anesthesia care (MAC) or general anesthesia (GA). MAC allows for interpretation of sensory and motor responses to optimize lead placement while GA only permits for motor assessment. However, patient discomfort and movement can make lead placement challenging during MAC. Herein we evaluate whether the anesthesia type impacts the progression rate to permanent implantation (SNM-II). MATERIALS AND METHODS: A retrospective chart review was performed for patients who underwent SNM-I in the operating room for wet overactive bladder between 2005 and 2023. Patients were divided into two groups based on the type of anesthesia used, MAC or GA. Clinical variables and progression to SNM-II were compared between cohorts. Progression to SNM-II was based on ≥50% symptomatic improvement during a 1-2 week trial period following SNM-I. RESULTS: Of 121 patients included in the study, 95 (79%) underwent MAC and 26 (21%) GA for SNM-I. No difference in the progression rate to SNM-II was noted between groups (MAC, 68/95 patients, 72%; GA, 19/26, 73%; p = 0.39). We also found no difference when comparing the GA group to the 26 most recent MAC patients (MAC, 20/26 patients, 77%; GA, 19/26, 73%; p = 0.48). CONCLUSION: Types of anesthesia for SNM-I did not affect rate of progression to SNM-II. The result lends support to the reliance on motor responses alone for lead placement during SNM-I.
Subject(s)
Anesthesia , Electric Stimulation Therapy , Urinary Bladder, Overactive , Humans , Retrospective Studies , Urinary Bladder, Overactive/diagnosis , Urinary Bladder, Overactive/therapy , Sacrum , Treatment OutcomeABSTRACT
OBJECTIVES: Sacral neuromodulation (SNM) therapy standard of care relies on visual-motor responses and patient-reported sensory responses in deciding optimized lead placement and programming. Automatic detection of stimulation responses could offer a simple, consistent indicator for optimizing SNM. The purpose of this study was to measure and characterize sacral evoked responses (SERs) resulting from sacral nerve stimulation using a commercial, tined SNM lead. MATERIALS AND METHODS: A custom external research system with stimulation and sensing hardware was connected to the percutaneous extension of an implanted lead during a staged (tined lead) evaluation for SNM. The system collected SER recordings across a range of prespecified stimulation settings (electrode configuration combinations for bipolar stimulation and bipolar sensing) during intraoperative and postoperative sessions in 21 subjects with overactive bladder (OAB) and nonobstructive urinary retention (NOUR). Motor and sensory thresholds were collected during the same sessions. RESULTS: SERs were detected in all 21 subjects. SER morphology (number of peaks, magnitude, and timing) varied across electrode configurations within and across subjects. Among subjects and electrode configurations tested, recordings contained SERs at motor threshold and/or sensory threshold in 75% to 80% of subjects. CONCLUSIONS: This study confirmed that implanted SNM leads can be used to directly record SERs elicited by stimulation in subjects with OAB and NOUR. SERs were readily detectable at typical SNM stimulation settings and procedural time points. Using these SERs as possible objective measures of SNM response has the capability to automate patient-specific SNM therapy, potentially providing consistent lead placement, programming, and/or closed-loop therapy.
Subject(s)
Electric Stimulation Therapy , Urinary Bladder, Overactive , Urinary Incontinence , Urinary Retention , Humans , Feasibility Studies , Lumbosacral Plexus/physiology , Urinary Bladder, Overactive/therapy , Urinary Incontinence/therapy , Electric Stimulation Therapy/methods , Urinary Retention/etiology , Urinary Retention/therapy , Sacrum/innervation , Treatment OutcomeABSTRACT
BACKGROUND: Sedentary work may lead to low back pain. In particular, a slumped sitting position may exacerbate low back pain because of tissue damage caused by excessive lumbar flexion and posterior pelvic tilting. Subjects with low back pain may have excessive changes in the lumbopelvic posture and back muscle activity in the sitting position. OBJECTIVE: The purpose of this study was to compare the effects of vibration-based biofeedback using a motion sensor belt and no biofeedback on multifidus (MF) muscle activity and pelvic tilt angle during typing. METHODS: Thirty subjects with low back pain accompanied by hip flexion limitation (15 each in the biofeedback and non-biofeedback groups) were enrolled. Electromyography was used to investigate MF muscle activity before and after typing for 30 min. Pelvic tilt was measured after typing in a sitting position for 30 min. Independent t-tests were used to compare MF muscle activity, and pelvic and second sacrum tilt angles, between the biofeedback and non-biofeedback groups. RESULTS: After typing for 30 min, changes in MF muscle activity (11.45% and -7.19% for the biofeedback and nonbiofeedback groups, respectively) and pelvic and second sacrum tilt angles (3.15∘ and 4.12∘ for the biofeedback group and -11.05∘ and -18.16∘ for the non-biofeedback group, respectively) were significantly smaller in the biofeedback than non-biofeedback group (p< 0.05). CONCLUSION: Vibration-based biofeedback minimizes the reduction in MF muscle activity and changes in pelvic and second sacrum tilt angles during typing in individuals with low back pain accompanied by hip flexion limitation.
Subject(s)
Low Back Pain , Humans , Low Back Pain/therapy , Paraspinal Muscles , Vibration/therapeutic use , Posture/physiology , Biofeedback, Psychology , SacrumABSTRACT
BACKGROUND: Sacral neuromodulation might be effective to palliate low anterior resection syndrome after rectal cancer surgery, but robust evidence is not available. OBJECTIVE: To assess the impact of sacral neuromodulation on low anterior resection syndrome symptoms as measured by validated scores and bowel diaries. DESIGN: Randomized, double-blind, 2-phased, controlled, multicenter crossover trial (NCT02517853). SETTINGS: Three tertiary hospitals. PATIENTS: Patients with major low anterior resection syndrome 12 months after transit reconstruction after rectal resection who had failed conservative treatment. INTERVENTIONS: Patients underwent an advanced test phase by stimulation for 3 weeks and received the pulse generator implant if a 50% reduction in low anterior resection syndrome score was achieved. These patients entered the randomized phase in which the generator was left active or inactive for 4 weeks. After a 2-week washout, the sequence was changed. After the crossover, all generators were left activated. MAIN OUTCOME MEASURES: The primary outcome was low anterior resection syndrome score reduction. Secondary outcomes included continence and bowel symptoms. RESULTS: After testing, 35 of 46 patients (78%) had a 50% or greater reduction in low anterior resection syndrome score. During the crossover phase, all patients showed a reduction in scores and improved symptoms, with better performance if the generator was active. At 6- and 12-month follow-up, the mean reduction in low anterior resection syndrome score was -6.2 (95% CI -8.97 to -3.43; p < 0.001) and -6.97 (95% CI -9.74 to -4.2; p < 0.001), with St. Mark's continence score -7.57 (95% CI -9.19 to -5.95, p < 0.001) and -8.29 (95% CI -9.91 to -6.66; p < 0.001). Urgency, bowel emptiness sensation, and clustering episodes decreased in association with quality-of-life improvement at 6- and 12-month follow-up. LIMITATIONS: The decrease in low anterior resection syndrome score with neuromodulation was underestimated because of an unspecific measuring instrument. There was a possible carryover effect in sham stimulation sequence. CONCLUSIONS: Neuromodulation provides symptoms and quality-of-life amelioration, supporting its use in low anterior resection syndrome. See Video Abstract . NEUROMODULACIN SACRA EN PACIENTES CON SNDROME DE RESECCIN ANTERIOR BAJA ENSAYO CLNICO ALEATORIZADO SANLARS: ANTECEDENTES:La neuromodulación sacra podría ser eficaz para paliar el síndrome de resección anterior baja después de la cirugía de cáncer de recto, pero no hay pruebas sólidas disponibles.OBJETIVO:Evaluar el impacto de la neuromodulación sacra en los síntomas del síndrome de resección anterior baja, medido mediante puntuaciones validadas y diarios intestinales.DISEÑO:Ensayo cruzado multicéntrico, controlado, aleatorizado, doble ciego, de dos fases (NCT02517853).LUGARES:Tres hospitales terciarios.PACIENTES:Pacientes con puntuación de resección anterior baja importante, 12 meses después de la reconstrucción del tránsito después de la resección rectal en quienes había fracasado el tratamiento conservador.INTERVENCIONES:Los pacientes se sometieron a una fase de prueba avanzada mediante estimulación durante tres semanas y se les implantó el generador de impulsos si se lograba una reducción del 50% en la puntuación del síndrome de resección anterior baja, ingresando a la fase aleatorizada en la que el generador se dejaba activo o inactivo durante cuatro semanas. Después de observar por 2 semanas, se cambió la secuencia. Después del cruce, todos los generadores quedaron activados.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la reducción de la puntuación del síndrome de resección anterior baja. Los resultados secundarios incluyeron continencia y síntomas intestinales.RESULTADOS:Después de las pruebas, 35 de 46 pacientes (78%) tuvieron una reducción ≥50% en la puntuación del síndrome de resección anterior baja. Durante el cruce, todos los pacientes mostraron una reducción en las puntuaciones y una mejora de los síntomas, con un mejor rendimiento si el generador estaba activo. A los 6 y 12 meses de seguimiento, la reducción media en la puntuación del síndrome de resección anterior baja fue -6,2 (-8,97; -3,43; p < 0,001) y -6,97 (-9,74; -4,2; p < 0,001), con Puntuación de continencia de St. Mark's -7,57 (-9,19; -5,95, p < 0,001) y -8,29 (-9,91; -6,66; p < 0,001). La urgencia, la sensación de vacío intestinal y los episodios de agrupamiento disminuyeron en asociación con una mejora en la calidad de vida a los 6 y 12 meses de seguimiento.LIMITACIONES:La disminución en la puntuación del síndrome de resección anterior baja con neuromodulación se subestimó debido a un instrumento de medición no específico. Posible efecto de arrastre en la secuencia de estimulación simulada.CONCLUSIONES:La neuromodulación mejora los síntomas y la calidad de vida, lo que respalda su uso en el síndrome de resección anterior baja. (Traducción-Dr. Mauricio Santamaria ).
Subject(s)
Electric Stimulation Therapy , Rectal Neoplasms , Humans , Low Anterior Resection Syndrome , Postoperative Complications/therapy , Postoperative Complications/diagnosis , Rectal Neoplasms/surgery , Retrospective Studies , Sacrum , Double-Blind MethodSubject(s)
Electric Stimulation Therapy , Humans , Electrodes, Implanted , Sacrum/surgery , FluoroscopyABSTRACT
PURPOSE: We compared fluctuations in treatment response after onabotulinumtoxinA and sacral neuromodulation for urgency incontinence using Markov models. MATERIALS AND METHODS: We fit data from a randomized trial to Markov models to compare transitions of success/failure over 6 months between 200 U onabotulinumtoxinA and sacral neuromodulation. Objective failure was <50% reduction in urgency incontinence episodes from baseline; subjective failure "strongly disagree" to "neutral" to the Patient Global Symptom Control questionnaire. RESULTS: Of the 357 participants (median baseline daily urgency incontinence episodes 4.7 [IQR 3.7-6.0]) 61% vs 51% and 3.2% vs 6.1% reported persistent states of objective success and failure over 6 months after onabotulinumtoxinA vs sacral neuromodulation. Participants receiving onabotulinumtoxinA vs sacral neuromodulation had lower 30-day transition probabilities from objective and subjective success to failure (10% vs 14%, ratio 0.75 [95% CI 0.55-0.95]; 14% vs 21%, ratio 0.70 [95% CI 0.51-0.89]). The 30-day transition probability from objective and subjective failure to success did not differ between onabotulinumtoxinA and sacral neuromodulation (40% vs 36%, ratio 1.11 [95% CI 0.73-1.50]; 18% vs 17%, ratio 1.14 [95% CI 0.65-1.64]). CONCLUSIONS: Over 6 months after treatment, 2 in 5 women's symptoms fluctuate. Within these initial 6 months, women receiving onabotulinumtoxinA transitioned from success to failure over 30 days less often than sacral neuromodulation. For both treatments, there was an almost 20%-40% probability over 30 days that women returned to subjective and objective success after failure. Markov models add important information to longitudinal models on how symptoms fluctuate after urgency incontinence treatment.
Subject(s)
Botulinum Toxins, Type A , Transcutaneous Electric Nerve Stimulation , Urinary Bladder, Overactive , Female , Humans , Botulinum Toxins, Type A/therapeutic use , Probability , Sacrum , Treatment Outcome , Urinary Bladder, Overactive/therapy , Urinary Incontinence, Urge/therapy , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: Sacral neuromodulation is an effective treatment for fecal incontinence. OBJECTIVE: To assess the long-term outcomes of sacral neuromodulation and establish the outcomes of patients with inactive devices. DESIGN: This is an observational study of patients treated for >5 years. A positive outcome was defined as a more than 50% reduction in fecal incontinence episodes or improvement in a symptom severity score. Data were reviewed from a prospectively managed database. SETTINGS: This study was conducted at a single tertiary referral center. PATIENTS: Data from 74 patients (72 women) were available at long-term follow-up. MAIN OUTCOME MEASURES: Bowel diary, St. Mark's incontinence score, and Manchester Health Questionnaire data were prospectively recorded at baseline, after percutaneous nerve evaluation, and at last follow-up. RESULTS: Patients were analyzed in cohorts based on time since sacral neuromodulation implantation: group 1: 5 to 10 years (n = 20), group 2: >10 years (n = 35), and group 3: inactive sacral neuromodulation devices (n = 19). Median St. Mark's incontinence score and Manchester Health Questionnaire improved from baseline to last follow-up in group 1 ( p ≤ 0.05) and group 2 ( p ≤ 0.05), but in group 3, results returned to baseline levels at the last follow-up. Similarly, weekly fecal incontinence episodes improved in both active device groups at the last follow-up. However, in group 3, incontinence episodes were no different from baseline ( p = 0.722). Despite active devices, fecal urgency episodes increased at the last follow-up after >10 years since percutaneous nerve evaluation ( p ≤ 0.05). Complete continence was reported by 44% of patients, and at least a 50% improvement was seen in 77% of patients with active devices. LIMITATIONS: This study is retrospective with some gaps in the available data at the last follow-up. CONCLUSIONS: Sacral neuromodulation is an effective treatment for fecal incontinence in the long term, but all outcomes are adversely affected by device inactivity. Therefore, ongoing stimulation is required for continued benefit. See Video Abstract. RESULTADOS A LARGO PLAZO DE LA NEUROMODULACIN SACRA PARA LA INCONTINENCIA FECAL EXPERIENCIA DE UN SOLO CENTRO: ANTECEDENTES:La neuromodulación sacra es un tratamiento eficaz para la incontinencia fecal.OBJETIVO:Este estudio tuvo como objetivo evaluar los resultados a largo plazo de la neuromodulación sacra y establecer los resultados de los pacientes con dispositivos inactivos.DISEÑO:Este es un estudio observacional de pacientes tratados durante más de 5 años. Un resultado positivo se definió como una reducción >50 % en los episodios de incontinencia fecal o una mejoría en la puntuación de gravedad de los síntomas. Los datos se revisaron a partir de una base de datos administrada prospectivamente.ENTERNO CLINICO:Este estudio se realizó en un solo centro de referencia terciario.PACIENTES:Los datos de 74 pacientes (72 mujeres) estaban disponibles en el seguimiento a largo plazo.PRINCIPALES MEDIDAS DE RESULTADO:Diario intestinal, puntuación de incontinencia de St. Mark y datos del Cuestionario de salud de Manchester se registraron prospectivamente al inicio, después de la evaluación de nervio periférico y en el último seguimiento.RESULTADOS:Los pacientes se analizaron en cohortes según el tiempo transcurrido desde la implantación de la neuromodulación sacra: Grupo 1: 5-10 años (n = 20), Grupo 2: >10 años (n = 35) y Grupo 3: dispositivos SNM inactivos (n = 19). La mediana de la puntuación de incontinencia de St. Mark y Questionnaire Cuestionario de salud de Manchester mejoraron desde el inicio hasta el último seguimiento en el Grupo 1 (p = < 0,05) y el Grupo 2 (p = < 0,05), pero en el Grupo 3 los resultados volvieron a los niveles iniciales en el último seguimiento. arriba. De manera similar, los episodios semanales de incontinencia fecal mejoraron en ambos grupos de dispositivos activos en el último seguimiento. Sin embargo, en el Grupo 3 los episodios de incontinencia no fueron diferentes de los basales (p = 0,722). A pesar de los dispositivos activos, los episodios de urgencia fecal aumentaron en el último seguimiento después de más de 10 años desde la evaluación del nervio periférico (p = < 0,05). Continencia completa se reportó en el 44 % de los pacientes, y al menos una mejora del 50 % en el 77 % con dispositivos activos.LIMITACIONES:Este estudio es retrospectivo con algunas vacíos en los datos disponibles en el último seguimiento.CONCLUSIONES:La neuromodulación sacra es un tratamiento eficaz para la incontinencia fecal a largo plazo, pero todos los resultados se ven afectados negativamente por la inactividad del dispositivo. Por lo tanto, se requiere estimulación continua para un beneficio continuo. (Traducción- Dr. Francisco M. Abarca-Rendon ).
Subject(s)
Electric Stimulation Therapy , Fecal Incontinence , Humans , Female , Fecal Incontinence/therapy , Retrospective Studies , Follow-Up Studies , SacrumABSTRACT
El Síndrome de Dolor Glúteo Profundo lo puede causar una fractura de fatiga del sacro. Objetivo: Facilitar el diagnóstico del Síndrome de Dolor Glúteo Profundo exponiendo un caso clínico y revisión bibliográfica de fractura de fatiga del sacro. Metodología: Búsqueda bibliográfica en PubMed sobre fractura de fatiga del sacro en atletas y descripción de un caso clínico de ésta. Resultados: Los principales factores predisponentes de una fractura de fatiga del sacro son las cargas desproporcionadas, baja densidad mineral ósea, alteraciones biomecánicas y una superficie de carrera dura. Estas fracturas son más frecuentes en corredores de larga distancia. El diagnóstico de elección es la Resonancia Magnética Nuclear. El tratamiento consiste en reposo de la actividad causante, suplementación con vitamina D y calcio y magnetoterapia. Se describe la clínica, exploraciones complementarias y evolución de un duatleta con fractura de fatiga de sacro. (AU)
Subject(s)
Humans , Fractures, Bone , Sacrum , Pain , Buttocks , FatigueABSTRACT
Despite the risk of complications, high dose radiation therapy is increasingly utilized in the management of selected bone malignancies. In this study, we investigate the impact of moderate to high dose radiation (over 50 Gy) on bone metabolism and structure. Between 2015 and 2018, patients with a primary malignant bone tumor of the sacrum that were either treated with high dose definitive radiation only or a combination of moderate to high dose radiation and surgery were prospectively enrolled at a single institution. Quantitative CTs were performed before and after radiation to determine changes in volumetric bone mineral density (BMD) of the irradiated and non-irradiated spine. Bone histomorphometry was performed on biopsies of the irradiated sacrum and the non-irradiated iliac crest of surgical patients using a quadruple tetracycline labeling protocol. In total, 9 patients were enrolled. Two patients received radiation only (median dose 78.3 Gy) and 7 patients received a combination of preoperative radiation (median dose 50.4 Gy), followed by surgery. Volumetric BMD of the non-irradiated lumbar spine did not change significantly after radiation, while the BMD of the irradiated sacrum did (pre-radiation median: 108.0 mg/cm3 (IQR 91.8-167.1); post-radiation median: 75.3 mg/cm3 (IQR 57.1-110.2); p = 0.010). The cancellous bone of the non-irradiated iliac crest had a stable bone formation rate, while the irradiated sacrum showed a significant decrease in bone formation rate [pre-radiation median: 0.005 mm3/mm2/year (IQR 0.003-0.009), post-radiation median: 0.001 mm3/mm2/year (IQR 0.001-0.001); p = 0.043]. Similar effects were seen in the cancellous and endocortical envelopes. This pilot study shows a decrease of volumetric BMD and bone formation rate after high-dose radiation therapy. Further studies with larger cohorts and other endpoints are needed to get more insight into the effect of radiation on bone. Level of evidence: IV.
Subject(s)
Bone Density , Sacrum , Humans , Pilot Projects , Sacrum/surgery , Lumbar Vertebrae , IliumABSTRACT
Pelvic surgery for endometriosis is associated with a risk of bladder and digestive sequelae. Sacral neuromodulation (SNM) has been shown to be effective in the treatment of overactive bladder (OAB) and voiding dysfunction (VD). This study aimed to evaluate the efficacy of sacral neuromodulation (SNM) in treating voiding dysfunction (VD) following endometriosis surgery. A retrospective analysis was conducted on data from women who underwent SNM testing for persistent VD after endometriosis surgery. The study included 21 patients from a French tertiary referral center. Patient characteristics, lower urinary tract symptoms, urodynamic findings, SNM procedures, and outcomes were assessed. The primary outcome was the success of SNM treatment for VD. After a median follow-up of 55 months, 60% of patients achieved successful outcomes, with significant improvements of VD and quality of life. Moreover, more than half of patients who required clean intermittent self-catheterization (CISC) before SNM were able to wean off CISC. Complications such as infections and paraesthesia were observed, but overall, SNM was found to be effective and well tolerated. Age and the interval between endometriosis surgery and SNM testing were associated with treatment success. This study adds to the limited existing literature on SNM for VD after endometriosis surgery and suggests that SNM can be a valuable therapeutic option for these patients. Further research is needed to identify predictive factors and mechanisms underlying the effectiveness of SNM in this context. MRI-compatible and rechargeable devices, has improved the feasibility of SNM for these patients. In conclusion, SNM offers promise as a treatment option for persistent VD after endometriosis surgery, warranting further investigation. LEVEL OF EVIDENCE: 4.
Subject(s)
Electric Stimulation Therapy , Endometriosis , Urinary Bladder, Overactive , Humans , Female , Retrospective Studies , Endometriosis/complications , Endometriosis/surgery , Quality of Life , Electric Stimulation Therapy/methods , Urinary Bladder, Overactive/etiology , Treatment Outcome , SacrumABSTRACT
CASE: A U-type sacral fracture, or spinopelvic dissociation, resulting from chiropractic manipulation has not been described in the medical literature. This report presents the case of a 74-year-old male patient who sustained a U-type sacral fracture after drop-table chiropractic manipulation. CONCLUSION: Our case demonstrates that chiropractic manipulative therapy involving the commonly used drop-table can cause severe injury. The patient's course was complicated by a delay in diagnosis and a prolonged hospital stay. Orthopaedic surgeons should have a high degree of suspicion for spinopelvic dissociation in the setting of bilateral sacral fractures. One year after injury, with conservative management, the patient returned to baseline function with mild residual neuropathy.
Subject(s)
Fractures, Bone , Manipulation, Chiropractic , Spinal Fractures , Male , Humans , Aged , Manipulation, Chiropractic/adverse effects , Fracture Fixation, Internal/methods , Spinal Fractures/therapy , Spinal Fractures/surgery , Fractures, Bone/surgery , Sacrum/injuriesABSTRACT
BACKGROUND: Over the last two decades, sacral neuromodulation (SNM) has established its role in the treatment of functional pelvic organ-/pelvic floor disorders. Even though the mode of action is not fully understood, SNM has become the preferred surgical treatment of fecal incontinence. METHODS AND RESULTS: A literature search was carried out on programming sacral neuromodulation and long-term outcomes in treating fecal incontinence and constipation.Sacral neuromodulation was found to be successful in the long term. Over the years, the spectrum of indications has expanded, and now includes patients presenting with anal sphincter lesions. The use of SNM for low anterior resection syndrome (LARS) is currently under clinical investigation. Findings of SNM for constipation are less convincing. In several randomised crossover studies, no success was demonstrated, even though it is possible that subgroups may benefit from the treatment. Currently the application cannot be recommended in general.The pulse generator programming sets the electrode configuration, amplitude, pulse frequency and pulse width. Usually pulse frequency and pulse width follow a default setting (14 Hz, 210 s), while electrode configuration and stimulation amplitude are adjusted individually to the patient need and perception of stimulation.Despite low infection rates and few electrode-/pulse generator dysfunctions, up to 65% of patients require surgical reintervention during long term follow-up - in 50% of cases because of battery depletion, which is an expected event. At least one reprogramming is necessary in about 75% of the patients during the course of the treatment, mostly because of changes in effectiveness, but rarely because of pain. Regular follow-up visits appear to be advisable. CONCLUSION: Sacral neuromodulation can be considered to be a safe and effective long-term therapy of fecal incontinence. To optimise the therapeutic effect, a structured follow-up regime is advisable.
Subject(s)
Electric Stimulation Therapy , Fecal Incontinence , Rectal Diseases , Rectal Neoplasms , Humans , Fecal Incontinence/therapy , Postoperative Complications/etiology , Postoperative Complications/therapy , Electric Stimulation Therapy/methods , Lumbosacral Plexus/physiology , Treatment Outcome , Rectal Neoplasms/therapy , Constipation/therapy , SacrumABSTRACT
OBJECTIVE: We systematically assessed all available evidence on the efficacy and safety of sacral neuromodulation (SNM) in pregnancy. METHODS: On September 2022, a thorough search was done on Ovid, PubMed, Scopus, ProQuest, Web of Science, and The Cochrane Library. We chose studies that included pregnant women who had SNM previously. Two authors independently evaluated the quality of the study using a standardized tool of JBI. Studies were given a risk of bias rating of low, moderate, or high. Given the descriptive nature of this study, we utilized descriptive statistics to report demographic and clinical features. For continuous variables, we used mean and standard deviation, and for dichotomous data, we used frequencies and percentages. RESULTS: Out of 991 abstracts screened, only 14 studies met our inclusion criteria and were included in the review. Overall, the quality of the evidence available from the literature is low based on the design of the included studies. Fifty-eight women, including 72 pregnancies, had SNM. The indication of SNM implantation was filling phase disorders in 18 cases (30.5%), voiding dysfunction in 35 women (59.3%), IC/BPS in two cases (3.5%), and fecal incontinence. In 38 pregnancies (58.5%), the SNM status was ON during pregnancy. Forty-nine cases delivered a full-term baby (75.4%), 12 cases had pre-term labor (18.5%), two miscarriages, and two postterm pregnancies happened. The most complications in patients with devices were urinary tract infection in 15 women (23.8%), urinary retention in six patients (9.5%), and pyelonephritis in two cases (3.2%). The findings revealed that when the device was deactivated, 11 cases out of the 23 patients (47.8%) had full-term pregnancies, while in ON status, 35 out of the 38 pregnant women (92.1%) had full-term pregnancies. Nine preterm labors in OFF (39.1%), and two in ON status (5.3%) were recorded. The results revealed that this difference was statistically significant (p = 0.002), and those who turned SNM of them off had more preterm labor. Although the studies reported all neonates had a healthy status, two children had chronic motor tic problems and a pilonidal sinus in a case with an active SNM in pregnancy. However, there was no association between the SNM status and pregnancy or neonatal complications (p = 0.057). CONCLUSION: SNM activation in pregnancy seems safe and effective. The choice of whether to activate or deactivate SNM should be made on an individual basis given the current SNM evidence.
Subject(s)
Electric Stimulation Therapy , Labor, Obstetric , Urinary Retention , Urinary Tract Infections , Child , Infant, Newborn , Humans , Pregnancy , Female , Electric Stimulation Therapy/adverse effects , Electric Stimulation Therapy/methods , Urinary Retention/etiology , Urinary Tract Infections/etiology , Sacrum , Treatment OutcomeABSTRACT
BACKGROUND AND OBJECTIVES: Sacrectomy is often the treatment of choice to provide the greatest chance of progression-free and overall survival for patients with primary malignant bone tumors of the sacrum. After midsacrectomy, the stability of the sacropelvic interface is diminished, resulting in insufficiency fractures. Traditional stabilization involves lumbopelvic fixation but subjects normal mobile segments to fusion. The purpose of this study was to determine whether standalone intrapelvic fixation is a safe adjunct to midsacrectomy, avoiding both sacral insufficiency fractures and the morbidity of instrumenting into the mobile spine. METHODS: A retrospective study identified all patients who underwent resection of sacral tumors at 2 comprehensive cancer centers between June 2020 and July 2022. Demographic, tumor-specific, operative characteristics and outcome data were collected. The primary outcome was presence of sacral insufficiency fractures. A retrospective data set of patients undergoing midsacrectomy without hardware placement was collected as a control. RESULTS: Nine patients (5 male, 4 female), median age 59 years, underwent midsacrectomy with concomitant placement of standalone pelvic fixation. No patients developed insufficiency fractures during the 216 days of clinical and 207 days of radiographic follow-up. There were no adverse events attributable to the addition of standalone pelvic fixation. In our historical cohort of partial sacrectomies without stabilization, there were 4/25 patients (16%) with sacral insufficiency fractures. These fractures appeared between 0 and 5 months postoperatively. CONCLUSION: A novel standalone intrapelvic fixation after partial sacrectomy is a safe adjunct to prevent postoperative sacral insufficiency fractures in patients undergoing midsacrectomy for tumor. Such a technique may allow for long-term sacropelvic stability without sacrificing mobile lumbar segments.
Subject(s)
Fractures, Stress , Humans , Male , Female , Middle Aged , Retrospective Studies , Fracture Fixation, Internal/methods , Sacrum/diagnostic imaging , Sacrum/surgery , PelvisABSTRACT
PURPOSE: We determined the utility of intraoperative data in predicting sacral neuromodulation outcomes in urgency urinary incontinence. MATERIALS AND METHODS: Intraoperative details of sacral neuromodulation stage 1 were recorded during the prospective, randomized, multicenter ROSETTA trial, including responsive electrodes, amplitudes, and response strengths (motor and sensory Likert scales). Stage 2 implant was performed for stage 1 success on 3-day diary with 24-month follow-up. An intraoperative amplitude response score for each electrode was calculated ranging from 0 (no response) to 99.5 (maximum response, 0.5 V). Predictors for stage 1 success and improvement at 24 months were identified by stepwise logistic regression confirmed with least absolute shrinkage and selection operator and stepwise linear regression. RESULTS: Intraoperative data from 161 women showed 139 (86%) had stage 1 success, which was not associated with number of electrodes generating an intraoperative motor and/or sensory response, average amplitude at responsive electrodes, or minimum amplitude-producing responses. However, relative to other electrodes, a best amplitude response score for bellows at electrode 3 was associated with stage 1 failure, a lower reduction in daily urgency urinary incontinence episodes during stage 1, and most strongly predicted stage 1 outcome in logistic modeling. At 24 months, those who had electrode 3 intraoperative sensory response had lower mean reduction in daily urgency urinary incontinence episodes than those who had no response. CONCLUSIONS: Specific parameters routinely assessed intraoperatively during stage 1 sacral neuromodulation for urgency urinary incontinence show limited utility in predicting both acute and long-term outcomes. However, lead position as it relates to the trajectory of the sacral nerve root appears to be important.
Subject(s)
Electric Stimulation Therapy , Transcutaneous Electric Nerve Stimulation , Urinary Bladder, Overactive , Urinary Incontinence , Humans , Female , Urinary Incontinence, Urge/surgery , Prospective Studies , Transcutaneous Electric Nerve Stimulation/methods , Urinary Incontinence/therapy , Sacrum/surgery , Lumbosacral Plexus , Treatment Outcome , Electric Stimulation Therapy/methods , Urinary Bladder, Overactive/therapyABSTRACT
OBJECTIVE: To present our experience removing sacral neuromodulation (SNM) components under local in the office. In some instances, SNM devices need to be removed. Traditionally, permanent lead and/or implantable pulse generator (IPG) removals are done in the operating room under sedation. However, it is our practice to perform this procedure in the office using only local anesthesia. MATERIALS AND METHODS: We performed a retrospective chart review from 2017 to 2022 of SNM lead and IPG removals performed under local anesthesia in the office by a single surgeon. Patient characteristics, outcomes, and complications were reported. RESULTS: From 2017 to 2022, 41 SNM leads with and without IPGs were removed in the office using local anesthesia. 88% were female, mean age 66 ± 15.8years, and mean body mass index 28.6 (19.1-49.4). The most common indications for SNM treatment were urgency incontinence (56%) and nonobstructive urinary retention (24%). 44% (18/41) of SNM device removals were leads removed after failed stage I and 56% (23/41) were leads with IPGs removed most commonly for decreased efficacy (52%). In the latter group, median time to removal was 3.1 (0.3-12.3) years, and 52% (12/23) required a separate medial incision for lead retrieval. 9% (2/23) required fluoroscopy, of which, one was planned secondary to body mass index 49.4, and the other needed secondary to excessive scar tissue. No stage I failures required fluoroscopy. 7% (3/41) of leads required cutdown to the sacrum for removal with leads in place between 3.1 and 3.9years. All leads were removed completely intact and there were no complications. CONCLUSION: Removal of SNM devices in the office using local anesthesia is effective, well-tolerated, and safe.