sacral neuromodulation

骶神经调节
  • 文章类型: Case Reports
    骶神经调节(SNM)通常用于治疗难治性膀胱过度活动症(OAB),非阻塞性尿潴留(NOR)和大便失禁。这里,我们报告了一个非典型症状病例,以丰富有限的国际病例系列。
    方法:我们报告一例男性患者,因外伤和排便功能异常而留下马尾神经损伤,在接受一期骶神经刺激器放置后,当机器打开时出现发烧,当它被关闭时,症状就会消失。
    骶神经调节(SNM)通常用于治疗难治性膀胱过度活动症(OAB),非阻塞性尿潴留(NOR)和大便失禁。病人受伤后没有出现非感染性发热,仅在安装并激活SNM设备后,停机后温度恢复正常。我们假设除了患者先前存在的神经损伤和疾病之外,SNM的激活以某种方式刺激了相关位点,导致病人出现神经性发热.
    结论:我们得出结论,在这种情况下,有理由认为患者的发热与骶神经刺激器的放置密切相关。
    UNASSIGNED: Sacral neuromodulation (SNM) is commonly used in the treatment of refractory overactive bladder (OAB), non-obstructive urinary retention (NOR) and fecal incontinence. Here, we report an atypical symptomatic case to enrich the limited international case series.
    METHODS: We report a case of a male patient with cauda equina nerve injury left over from a traumatic injury and dysfunction of urinary and fecal functions who, after undergoing phase I sacral nerve stimulator placement, developed fever when the machine was switched on, and the symptoms resolved when it was switched off.
    UNASSIGNED: Sacral neuromodulation (SNM) is commonly used in the treatment of refractory overactive bladder (OAB), non-obstructive urinary retention (NOR) and fecal incontinence. The patient did not develop a non-infectious fever after the injury, only after the SNM device was installed and activated, and the temperature returned to normal after shutdown. We hypothesize that on top of the patient\'s pre-existing nerve damage and disorders, the activation of the SNM somehow stimulated the relevant sites, causing the patient to develop a neurogenic fever.
    CONCLUSIONS: We concluded that in this case, it is reasonable to consider that the patient\'s fever was closely related to the placement of the sacral nerve stimulator.
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    文章类型: Journal Article
    背景:尽管关于骶神经调节(SNM)结果的文献越来越多,以男性患者为重点的研究仍然有限,并且通常由嵌套在主要是女性的更大研究中的小队列代表。在这里,我们评估了SNM在男性膀胱过度活动症(OAB)队列中的结局,大便失禁(FI),慢性膀胱疼痛,和神经源性下尿路功能障碍(NLUTD)。
    方法:这项回顾性队列研究包括2013年至2021年在大批量三级中心进行SNM插入的64名男性患者。SNM治疗的适应症包括OAB,FI,慢性盆腔疼痛,和NUTD。描述性统计,分析采用Fisher检验和t检验。
    结果:平均年龄为57.7±13.4岁,SNM插入的最常见原因是特发性OAB(72%),FI(16%),盆腔疼痛(11%),和NUTD(11%)。大多数(84%)的男性在插入SNM之前接受了治疗。84%的人在第一年内报告满意度和92%的症状改善,这些改善在73%的患者中持续超过1年.平均随访52.7±21.0个月。并发症发生率为23%,对辅助治疗的需求显著减少(73%至27%,p<0.001)。对于SNM治疗的各种适应症或良性前列腺增生(BPH)的存在,治疗结果没有显着差异。
    结论:SNM是治疗男性神经源性和非神经源性OAB的有效和安全的方法,盆腔疼痛,和FI。超过70%的患者经历了症状改善,并在中长期随访中保持满意。BPH似乎并不妨碍治疗结果。
    BACKGROUND: Despite the growing body of literature on sacral neuromodulation (SNM) outcomes, research focusing on male patients remains limited and often represented by small cohorts nested within a larger study of mostly women. Herein, we evaluated the outcomes of SNM in a male-only cohort with overactive bladder (OAB), fecal incontinence (FI), chronic bladder pain, and neurogenic lower urinary tract dysfunction (NLUTD).
    METHODS: This retrospective cohort study included 64 male patients who underwent SNM insertion between 2013 and 2021 at a high-volume tertiary center. Indications for SNM therapy included OAB, FI, chronic pelvic pain, and NLUTD. Descriptive statistics, Fisher\'s and t-test were used in analysis.
    RESULTS: The mean age was 57.7 ± 13.4 years, and the most frequent reason for SNM insertion was idiopathic OAB (72%), FI (16%), pelvic pain (11%), and NLUTD (11%). A majority (84%) of men received treatment prior to SNM insertion. 84% reported satisfaction and 92% symptom improvement within the first year, and these improvements persisted beyond 1 year in 73% of patients. Mean follow up was 52.7 ± 21.0 months. The complication rate was 23%, and the need for adjunct treatments was significantly reduced (73% to 27%, p < 0.001). Treatment outcomes did not differ significantly between various indications for SNM therapy or the presence of benign prostatic hyperplasia (BPH).
    CONCLUSIONS: SNM is an effective and safe procedure for male patients with neurogenic and non-neurogenic OAB, pelvic pain, and FI. Over 70% of patients experienced symptomatic improvement and remained satisfied in the mid to long term follow up. BPH does not seem to hinder treatment outcomes.
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  • 文章类型: Case Reports
    神经元核内包涵体病是一种罕见的神经退行性疾病。根据目前的研究,这种情况的诊断变得更加明确。然而,治疗方案仍然有限。神经源性下尿路功能障碍是常见且显著的并发症之一,这是其多系统效应的结果。这里,我们介绍了一例48岁男性患者,根据现有证据诊断为神经元核内包涵体疾病,并发神经源性下尿路功能障碍.尽管接受了一些治疗,他的下尿路症状,包括尿失禁,不完全或间歇性排尿,etc,在上尿路损伤发展期间继续恶化。在仔细考虑患者病情和现有发现的基础上,我们对他进行了前所未有的骶神经调节。实施骶神经调节可显著改善患者排尿功能,减轻肾功能损害。我们的病例表明,骶神经调节在治疗与神经元核内包涵体病相关的神经源性下尿路功能障碍中具有潜在的治疗作用。需要进一步的研究来确定骶神经调节在治疗由各种病因引起的神经源性下尿路功能障碍中的有效性。
    Neuronal intranuclear inclusion disease is an uncommon neurodegenerative disorder. The diagnosis of this condition has become more definitive based on current research. However, treatment options remain limited. Neurogenic lower urinary tract dysfunction is one of the prevalent and significant complications, which is the result of its multi-system effects. Here, we present the case of a 48-year-old man diagnosed with neuronal intranuclear inclusion disease based on existing evidence and was complicated by neurogenic lower urinary tract dysfunction. Despite undergoing some medical treatments, his lower urinary tract symptoms, including urinary incontinence, incomplete or intermittent voiding, etc, continued to worsen while upper urinary tract injury developed. Based on careful consideration of the patient\'s condition and the available findings, we performed an unprecedented sacral neuromodulation on him. Implementation of sacral neuromodulation led to significant improvement in his urination function and alleviate kidney function damage. Our case suggests a potential therapeutic role for sacral neuromodulation in the treatment of neurogenic lower urinary tract dysfunction associated with neuronal intranuclear inclusion disease. Additional research is required to determine the effectiveness of sacral neuromodulation in managing neurogenic lower urinary tract dysfunction caused by various etiologies.
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  • 文章类型: Journal Article
    目的:目的是描述65岁以上女性因膀胱过度活动症(OAB)适应症而在骶神经调节(SNM)后8年长期与器械相关的再手术。大便失禁(FI),和/或特发性尿潴留(UR)。
    方法:2010-2019年Medicare100%门诊有限数据集用于识别65岁及以上接受SNM治疗OAB的女性,FI,和/或UR。主要研究结果是在初始植入式脉冲发生器(IPG)植入后8年内任何与设备相关的再手术,定义为:IPG修正或移除;IPG替换;或神经电极修正或移除。还进行了Kaplan-Meier生存分析以评估不良事件发生时间。
    结果:该队列包括32,454名平均年龄为74岁的女性。SNM最常见的指征是OAB(71%),其次是UI和FI(13%)和仅FI(8%)。与经皮神经评估/完整植入物相比,阶段性SNM程序的执行频率更高(60%)。8年内器械相关再手术的总比率为24%:12%的患者接受了神经电极的切除或翻修,11%接受了IPG的移除或修订,13%的人更换了IPG。平均随访3.9±2.4年。1年内任何器械相关再手术的累计发生率为9.4%,3年内20%,和43%在8年。
    结论:在SNM植入后的8年中,女性医疗保险受益人中与设备相关的再手术率为43%,和分期植入与接受任何器械相关再手术的可能性降低17%相关.
    OBJECTIVE: The objective was to describe long-term device-related reoperations at 8 years following sacral neuromodulation (SNM) in women older than 65 years for the indications of overactive bladder (OAB), fecal incontinence (FI), and/or idiopathic urinary retention (UR).
    METHODS: The 2010-2019 Medicare 100% Outpatient Limited Dataset was used to identify women aged 65 years and older who underwent SNM to treat OAB, FI, and/or UR. The primary study outcome was any device-related reoperation within 8 years following initial implantable pulse generator (IPG) implantation defined as: IPG revision or removal; IPG replacement; or neuro-electrode revision or removal. Kaplan-Meier survival analysis was also performed to evaluate time to adverse event.
    RESULTS: The cohort included 32,454 women with a mean age of 74 years. The most common indication for SNM was OAB (71%) followed by UI and FI (13%) and FI only (8%). Staged SNM procedures were performed more frequently (60%) than percutaneous nerve evaluation/full implants. The overall rate of device-related reoperations was 24% over 8 years: 12% of patients underwent removal or revision of the neuro-electrode, 11% underwent removal or revision of the IPG, and 13% underwent replacement of the IPG. The mean follow-up was 3.9 ± 2.4 years. The cumulative incidence of any device-related reoperations was 9.4% at 1 year, 20% at 3 years, and 43% at 8 years.
    CONCLUSIONS: In the 8 years following SNM implantation, the rate of device-related reoperation among female Medicare beneficiaries was 43%, and staged implants were associated with a 17% lower likelihood of undergoing any device-related reoperations.
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  • 文章类型: Journal Article
    目的:骶神经调节(SNM)已被证明可以减轻膀胱过度活动症和非梗阻性尿潴留患者的膀胱功能障碍。然而,SNM在神经源性膀胱功能障碍中的治疗作用和机制尚不完全清楚。使用大鼠脊髓损伤(SCI)模型,本研究旨在探讨膀胱反射期早期SNM对神经源性膀胱功能障碍的治疗作用及其可能机制。
    方法:基本生理参数,如身体/膀胱重量,血压,并测量心电图结果以评价SNM的安全性。酶联免疫吸附试验和实时定量聚合酶链反应检测促炎因子的表达。苏木素、伊红和马森三色染色观察形态学变化,和膀胱测压用于评估SNM治疗后的尿动力学变化。采用蛋白质印迹和免疫荧光染色检测L6-S1背根神经节(DRGs)和膀胱瞬时受体电位香草酸1(TRPV1)和降钙素基因相关肽(CGRP)水平。辣椒素脱敏用于研究抑制TRPV1是否可以预防SCI大鼠逼尿肌过度活动。
    结果:早期SNM不影响身体/膀胱重量,心率,血压,或促炎细胞因子的表达(PGE2,IL-1,IL-2,IL-6,TGF-β,或TNF-α)在SCI大鼠的膀胱中。形态学上,早期SNM可以预防尿路上皮水肿(p=0.0248),但不影响膀胱中的胶原蛋白/平滑肌。与未经治疗的SCI大鼠相比,SNM治疗的大鼠表现出增加的膀胱容量(p=0.0132)和排尿效率(p=0.0179),无排尿收缩(NVC)频率降低(p=0.0240)。最大压力,基础压力,后空隙残留,NVC振幅无明显变化。SNM治疗后,SCI大鼠膀胱中TRPV1和L6-S1DRGs中CGRP的表达降低(L6,p=0.0160;S1,p=0.0024)。在辣椒素脱敏的SCI大鼠中,尿动力学结果显示膀胱容量(p=0.0116)和排尿效率(p=0.0048)增加,和减少的NVC频率(p=0.0116),而其他参数没有明显变化。
    结论:早期SNM可在形态学上预防SCI大鼠尿路上皮水肿和逼尿肌过度活动。抑制膀胱和DRGs中的TRPV1可能是SNM预防逼尿肌过度活动的潜在机制之一。
    OBJECTIVE: Sacral neuromodulation (SNM) has been shown to alleviate bladder dysfunction in patients with overactive bladder and nonobstructive urinary retention. However, the therapeutic effect and mechanism of SNM in neurogenic bladder dysfunction are still not fully understood. Using a rat model of spinal cord injury (SCI), this study aims to investigate the therapeutic effect of early SNM in the bladder-areflexia phase on neurogenic bladder dysfunction and evaluate its possible mechanism.
    METHODS: Basic physiological parameters such as body/bladder weight, blood pressure, and electrocardiogram results were measured to evaluate the safety of SNM. Enzyme-linked immunosorbent assays and quantitative real-time polymerase chain reaction were used to examine the expression of proinflammatory factors. Hematoxylin and eosin and Masson\'s trichrome staining were used to observe morphological changes, and cystometry was used to evaluate urodynamic changes after SNM treatment. Western blotting and immunofluorescence staining were used to measure the levels of transient receptor potential vanilloid 1 (TRPV1) and calcitonin gene-related peptide (CGRP) in the L6-S1 dorsal root ganglia (DRGs) and bladder. Capsaicin desensitization was used to investigate whether inhibiting TRPV1 could prevent detrusor overactivity in SCI rats.
    RESULTS: Early SNM did not affect the body/bladder weight, heart rate, blood pressure, or the expression of proinflammatory cytokines (PGE2, IL-1, IL-2, IL-6, TGF-β, or TNF-α) in the bladders of SCI rats. Morphologically, early SNM prevented urothelial edema (p = 0.0248) but did not influence collagen/smooth muscle in the bladder. Compared with untreated rats with SCI, the rats treated with SNM exhibited increased bladder capacity (p = 0.0132) and voiding efficiency (p = 0.0179), and decreased nonvoiding contraction (NVC) frequency (p = 0.0240). The maximum pressure, basal pressure, postvoid residual, and NVC amplitude did not change significantly. After the SNM treatment, the expression of TRPV1 in the bladder and CGRP in L6-S1 DRGs weredecreased (L6, p = 0.0160; S1, p = 0.0024) in SCI rats. In capsaicin-desensitized SCI rats, urodynamic results showed an increase in bladder capacity (p = 0.0116) and voiding efficiency (p = 0.0048), and diminished NVC frequency (p = 0.0116), while other parameters did not change significantly.
    CONCLUSIONS: Early SNM prevented urothelial edema morphologically and detrusor overactivity in SCI rats. Inhibition of TRPV1 in the bladder and DRGs may be one of the potential mechanisms for preventing detrusor overactivity by SNM.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    骶神经调节(SNM)是一种安全的,有效的,和微创先进疗法,包括电刺激骶神经根以调节神经通路。SNM的适应症包括膀胱过度活动症(OAB)的症状,尿失禁,尿潴留,紧迫性和频率,关于肠功能障碍,大便失禁.在欧洲和加拿大,慢性便秘也有适应症。作用机制仍未完全阐明,完整的理解尚待确定。建议SNM调节中枢和外周通路的神经回路,从而对大脑产生影响,以及针对膀胱的神经元活动。对不规则膀胱活动的另一种可能的显着影响是通过刺激阴部神经来抑制膀胱传入途径。在过去的二十年里,有超过30万名接受治疗的患者,SNM已证实其有效缓解难治性OAB症状,以及尿潴留或大便失禁。克罗地亚的首次SNM应用进展顺利,我们很高兴将来为患者提供这种新疗法。
    Sacral neuromodulation (SNM) is a safe, efficacious, and minimally invasive advanced therapy that involves electrical stimulation to sacral nerve root to modulate neural pathway. Indications for SNM include symptoms of overactive bladder (OAB), urinary incontinence, urinary retention, urgency and frequency and, regarding bowel dysfunction, fecal incontinence . In Europe and Canada, indication is also established for chronic constipation. The mechanism of action is still not fully elucidated and complete understanding is yet to be determined. It is proposed that SNM modulates neural circuits in both central and peripheral pathways, thus having an impact on the brain, as well as on the bladder-targeting neuronal activity. Another possible significant effect on irregular bladder activity is through inhibition of the bladder afferent pathways by stimulation of the pudendal nerve. Over the past two decades, with more than 300 000 treated patients, SNM has confirmed its efficacy to relieve refractory OAB symptoms, as well as urinary retention or fecal incontinence. First SNM applications in Croatia were uneventful and we are glad to offer our patients this novel therapy in the future.
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  • 文章类型: Journal Article
    目的:本研究评估了由于低位前切除综合征(LARS)而接受骶神经调节(SNM)的患者的长期结局和生活质量。
    方法:这项单中心回顾性研究,从2005年到2021年进行,包括30名患者(21名男性;平均年龄,70岁)的患者接受了全直肠系膜切除术并关闭了造口,并且在纳入时没有复发。所有患者均诊断为保守治疗难治性LARS。我们通过粪便日记评估SNM后的临床和生活质量结果,Wexner得分,LARS得分,大便失禁生活质量(FIQL)问卷,和EuroQol-5D(EQ-5D)问卷。
    结果:除一名患者外,所有患者均能成功刺激周围神经。在29例接受经皮神经评估的患者中,17(58.62%)对SNM反应良好,并接受了永久性植入物。中位随访期为48个月(范围,18-153个月)。每周大便失禁发作的天数从中位数7天减少(范围,2-7)至0.38(范围,0-1)。患者日记中记录的排便中位数从5下降(范围,4-12)到2(范围,1-6).Wexner评分中位数从18分下降(范围,13-20)到6(范围,0-16),而LARS得分从38.5(范围,37-42)至19(范围,4-28).FIQL和EQ-5D问卷显示生活质量提高。
    结论:当保守选择失败时,SNM可能使直肠癌手术后诊断为LARS的患者受益。治疗结果可能具有长期可持续性。
    OBJECTIVE: This study assessed the long-term outcomes and quality of life in patients who underwent sacral neuromodulation (SNM) due to low anterior resection syndrome (LARS).
    METHODS: This single-center retrospective study, conducted from 2005 to 2021, included 30 patients (21 men; median age, 70 years) who had undergone total mesorectal excision with stoma closure and had no recurrence at inclusion. All patients were diagnosed with LARS refractory to conservative treatment. We evaluated clinical and quality-of-life outcomes after SNM through a stool diary, Wexner score, LARS score, the Fecal Incontinence Quality of Life (FIQL) questionnaire, and EuroQol-5D (EQ-5D) questionnaire.
    RESULTS: Peripheral nerve stimulation was successful in all but one patient. Of the 29 patients who underwent percutaneous nerve evaluation, 17 (58.62%) responded well to SNM and received permanent implants. The median follow-up period was 48 months (range, 18-153 months). The number of days per week with fecal incontinence episodes decreased from a median of 7 (range, 2-7) to 0.38 (range, 0-1). The median number of bowel movements recorded in patient diaries fell from 5 (range, 4-12) to 2 (range, 1-6). The median Wexner score decreased from 18 (range, 13-20) to 6 (range, 0-16), while the LARS score declined from 38.5 (range, 37-42) to 19 (range, 4-28). The FIQL and EQ-5D questionnaires demonstrated enhanced quality of life.
    CONCLUSIONS: SNM may benefit patients diagnosed with LARS following rectal cancer surgery when conservative options have failed, and the treatment outcomes may possess long-term sustainability.
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  • 文章类型: Journal Article
    Following a description of the historic evolution of botulinum toxin A detrusor injections for neurogenic and nonneurogenic bladder overactivity, which was mainly driven by German-speaking countries, the terminological revolution of 2002 and the influence on design and outcomes of upcoming approval studies for the indication overactive bladder (OAB) are examined. OnabotulinumtoxinA (100 IU) for second-line treatment of OAB received European approval in 2013. Phase IV observational studies concerning therapeutic persistence and adherence with onabotulinumtoxinA are analyzed and compared with therapeutic alternatives. Predictors of treatment success and complications are identified and compared to the required preinterventional diagnostic effort. Since onabotulinumtoxinA and sacral neuromodulation (SNM) are competing for second-line OAB treatment, both options are compared with regard to differential indications, effectivity, durability and patient adherence. Gender-specific causes of urgency and urge incontinence in women are differentiated from the diagnosis of OAB and require priority treatment. On the basis of diagnostic examination results, an algorithm for invasive second-line treatment of OAB is presented, since overly liberal utilization of onabotulinumtoxinA in therapy-naive OAB patients has not proven superiority over oral antimuscarinergic standard therapy, which can only be explained by improper patient selection.
    UNASSIGNED: Nach einer Darstellung der historischen Entwicklung der maßgeblich aus dem deutschen Sprachraum vorangetriebenen Botulinumtoxin A-Detrusorinjektion bei neurogener und nichtneurogener Blasenüberaktivität werden die terminologischen Umwälzungen des Jahres 2002 und ihr Einfluss auf Design und Ergebnisse der Zulassungsstudien für das Indikationsgebiet OAB (überaktive Harnblase) erläutert. Die europäische Zulassung von 100 IE Botulinumtoxin A zur Zweitlinientherapie der OAB erfolgte 2013. Phase-IV-Langzeitbeobachtungsstudien zur Therapietreue von mit Botulinumtoxin A behandelten Frauen werden analysiert und mit Therapiealternativen verglichen. Erfolgs- und Komplikationsprognostikatoren werden identifiziert und dem zu ihrer Ermittlung nötigen präinterventionellen diagnostischen Aufwand gegenübergestellt. Da Botulinumtoxin A und die sakrale Neuromodulation (SNM) als invasive Zweitlinientherapien miteinander konkurrieren, werden beide Verfahren in Bezug auf Differentialindikationen, Wirksamkeit, Beständigkeit und Therapietreue der OAB-Patientinnen verglichen. Geschlechtsspezifische Ursachen für Drang und Dranginkontinenz bei Frauen werden als prioritär behandlungsbedürftig von der Ausschlussdiagnose OAB abgegrenzt. Auf der Basis diffentialdiagnostischer Untersuchungsergebnisse wird ein Algorithmus zur invasiven Zweitlinienbehandlung therapierefraktärer OAB-Patientinnen vorgestellt, da der zu freizügige Botulinumtoxin A-Einsatz bei therapienaiven OAB-Patientinnen trotz höherer Invasivität der oral-antimuskarinergen Standardtherapie nachweislich nicht überlegen ist, was nur mit einer ungeeigneten Patientenselektion erklärt werden kann.
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  • 文章类型: Journal Article
    目的:骶神经调节(SNM)已发展成为各种骨盆底功能障碍的治疗干预措施。然而,传统方法主要评估特定学科的症状,可能忽视整体症状改善。我们旨在调查更全面的盆底症状评估是否能提高SNM测试阶段的评估。
    方法:一项前瞻性单中心试验(下尿路症状优化研究)评估了2018年3月至2021年12月在泌尿外科(UD)和结直肠外科(CRD)患者中的SNM疗效,随访12个月。使用日记和患者报告的结果指标检查客观和主观结果。进行统计分析以确定治疗成功的预测因素。通过患者对变化的全球印象来表达。使用SPSS29.0。
    结果:共纳入85名参与者,显示伴随的盆底症状。第一阶段之后,UD和CRD患者的所有盆底领域问卷均有显著改善.尽管在膀胱和肠日记中观察到改善,传统的成功标准(日记变量改善≥50%)与患者的总体改变印象并不一致.来自多个领域的burgesum得分的绝对减少是患者对整体变化印象的显著预测因子,优于特定学科的评估。UD患者受益于泌尿科和盆腔疼痛症状评估,和那些来自CRD的人,从泌尿科和肠道症状评估。
    结论:SNM在不同的盆底领域显示出积极的影响,甚至超出了主要的植入指征。可以质疑仅患者选择特定学科症状的相当严格的方法。更全面的评估包括各种盆底症状,并强调主观结局指标,可以在测试阶段提高SNM的疗效评估。
    背景:本研究的Clinicaltrials.gov注册号为NCT05313984。
    OBJECTIVE: Sacral neuromodulation (SNM) has evolved as a therapeutic intervention for various pelvic floor dysfunctions. However, the traditional approach primarily assesses discipline-specific symptoms, potentially overlooking holistic symptom improvement. We aimed to investigate whether a more comprehensive evaluation of pelvic floor symptoms enhances the assessment of SNM\'s test phase.
    METHODS: A prospective single-center trial (Optimization of Lower Urinary Tract Symptoms study) assessed SNM efficacy from March 2018 to December 2021 in patients from the urology department (UD) and colorectal surgery department (CRD) with a follow-up of 12 months. Objective and subjective outcomes were examined using diaries and patient-reported outcome measures. Statistical analyses were conducted to determine predictive factors for treatment success, expressed by the patient global impression of change. SPSS 29.0 was used.
    RESULTS: A total of 85 participants were included, displaying concomitant pelvic floor symptoms. After the first phase, significant improvements on all pelvic floor domains questionnaires were seen for both patients from UD and those from CRD. Although improvements were observed in bladder and bowel diaries, the traditional criteria for success (≥50% improvement in diary variables) did not consistently correlate with the patients\' global impression of change. The absolute reductions in bother sum scores from multiple domains were significant predictors for the patients\' global impression of change, outperforming discipline-specific assessments. Patients from UD benefit from both a urologic and pelvic pain symptom evaluation, and those from CRD, from both a urologic and bowel symptom evaluation.
    CONCLUSIONS: SNM shows positive effects across various pelvic floor domains, even beyond the primary intended indication of implantation. The rather rigid approach of patient selection of discipline-specific symptoms alone can be questioned. A more comprehensive evaluation encompassing various pelvic floor symptoms with the emphasis on subjective outcome measures could enhance SNM\'s efficacy assessment during the test phase.
    BACKGROUND: The Clinicaltrials.gov registration number for the study is NCT05313984.
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