Noninvasive Sacral Neuromodulation in Children and Adolescents: A Case-Control Study of Patients With Chronic Refractory Constipation

Diez, Sonja; Kirchgatter, Annemarie; Adam, Dana; Füldner, Arne; Müller, Hanna; Matzel, Klaus E.; Besendörfer, Manuel

doi:10.1016/j.neurom.2022.08.451

Cited by 5 publications

(5 citation statements)

References 24 publications

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“…Out of 345 articles identified by the database searches, 49 articles met the inclusion criteria. 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 Most concerned esophageal atresia ( n = 17) and Hirschsprung's disease ( n = 14). None of the articles focused on duodenal atresia or omphalocele.…”

Section: Resultsmentioning

confidence: 99%

“…Out of the 29 PROMs identified, most ( n = 28) were applied in observational studies ( n = 47), while only two studies employed an experimental, randomized trial design. 34 60 The majority of articles employed PROMs to enhance understanding of the respective medical conditions and treatment strategies under investigation ( n = 44). One study was dedicated to the development of a specific PROM, known as the Diet and Bowel Questionnaire.…”

Section: Resultsmentioning

confidence: 99%

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A Narrative Review of Patient-Reported Outcome Measures and Their Application in Recent Pediatric Surgical Research: Advancing Knowledge and Offering New Perspectives to the Field

Spivack,

Dellenmark-Blom,

Dingemann

et al. 2024

Eur J Pediatr Surg

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Introduction Patient-reported outcome measures (PROMs) can be employed in both research and clinical care to enhance our understanding of outcomes that matter to patients. This narrative review aims to describe PROM use in recent pediatric surgical research, identify and describe psychometrically robust PROMs, providing an overview of those derived from pediatric patient input, and make recommendations for future research. Materials and Methods A search was conducted to identify articles published from 2021 to August 2023 describing the availability and/or use of at least one valid or reliable PROM in children with conditions including anorectal malformations, biliary atresia, congenital diaphragmatic hernia, duodenal atresia, esophageal atresia, abdominal wall defects, Hirschsprung's disease, sacrococcygeal teratoma, and short bowel syndrome. Articles were categorized based on their objectives in applying PROMs. Psychometrically robust PROMs were identified and described. Results Out of the 345 articles identified, 49 met the inclusion criteria. Seventeen focused on esophageal atresia and 14 on Hirschsprung's disease. Twenty-nine PROMs were identified, with 12 deemed psychometrically robust. Seven psychometrically robust PROMs were developed using patient input in the primary item generation. Most PROMs were applied to advance understanding of conditions and/or treatment and fewer were developed or psychometrically evaluated. No PROMs were assessed for their impact or incorporated into an implementation study. Conclusions This review reveals gaps in the application of PROMs in recent pediatric surgical research. Emphasis should be placed on the development and utilization of psychometrically robust PROMs, broadening the scope of covered diseases, conducting impact assessments, and evaluating implementation strategies.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

A Narrative Review of Patient-Reported Outcome Measures and Their Application in Recent Pediatric Surgical Research: Advancing Knowledge and Offering New Perspectives to the Field

Spivack,

Dellenmark-Blom,

Dingemann

et al. 2024

Eur J Pediatr Surg

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“…Previously published outcomes of invasive and non-invasive sacral neuromodulation do predominantly not allow to draw rm conclusions because of small populations and high heterogeneity in outcome measures and participants. We were able to publish the rst prospective randomized trial in 2022 on the e cacy of ENM (non-invasive SNM) in children and adolescents [11]. Patients, refractory to conventional treatment options, were in the study and were randomized to either an optimization of these conventional options or to ENM under unchanged continuation of conventional options.…”

Section: Discussionmentioning

confidence: 99%

“…The stimulation is applied with a frequency of 15 Hz and a pulse width of 210µs. Detailed stimulation techniques have been described previously [5] and are administered via a pulse generator (Ostimex® Pro Plus TENS/EMS 335035) [11]. The adhesive electrodes (50x50mm in size) have a conductive surface and adhere to the skin by themselves.…”

Section: Enteral Neuromodulation (Enm)mentioning

confidence: 99%

Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents – study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique

Besendörfer,

Kirchgatter,

Carbon

et al. 2024

Preprint

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Background A therapeutic effect of sacral neuromodulation (SNM) on fecal incontinence (FI) and quality of life has been proven in adults. SNM is, however, rarely used in pediatric cases. The aim of the study is to investigate effects of SNM in pediatric constipation in a prospective parallel-group trial. Methods A monocentric, randomized, unblinded, parallel-group trial is conducted. SNM is conducted in the invasive variant and in an innovative, external approach with adhesive electrodes (enteral neuromodulation, ENM). We include patients with constipation according to the ROME IV criteria and refractory to conventional options. Patients with functional constipation and Hirschsprung’s disease are able to participate. Participants are allocated in a 1:1 ratio to either SNM or ENM group. Clinical data and quality of life is evaluated in regular check-ups. Neuromodulation is applied continuously for 3 months (end point of the study) with follow-up-points at 6 and 12 months. Findings are analyzed statistically considering a 5% significance level (p ≤ 0.05). Outcome variables are defined as change in (1) episodes of abdominal pain, (2) episodes of FI, (3) defecation frequency, (4) stool consistency. Improvement of proprioception, influence on urinary incontinence, quality of life and safety of treatment are assessed as secondary outcome variables. We expect a relevant improvement in both study groups. Discussion This is the first trial, evaluating effects of neuromodulation for constipation in children and adolescents and comparing effects of the invasive and non-invasive application (SNM vs. ENM). Trial registration The study is registered with clinicaltrials.gov, Identifier NCT04713085 (date of registration 01/14/2021).

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“…SNM utilizes electrical stimulation to modulate neural structures and improve functionality 6,7 . A non‐invasive version of SNM has shown effectiveness in pediatric patients with constipation and fecal incontinence in a recent randomized controlled trial 8 . While the traditional surgical implantation of electrodes and pulse generators for SNM has not yet become a routine clinical option for these pediatric patients, it represents a potential therapeutic avenue worth exploring further.…”

Section: Introductionmentioning

confidence: 99%

Sacral neuromodulation in children and adolescents with defecation disorders

Besendörfer,

Knorr,

Kirchgatter

et al. 2024

Neurogastroenterology Motil

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BackgroundEven if understanding of neuronal enteropathies, such as Hirschsprung's disease and functional constipation, has been improved, specialized therapies are still missing. Sacral neuromodulation (SNM) has been established in the treatment of defecation disorders in adults. The aim of the study was to investigate effects of SNM in children and adolescents with refractory symptoms of chronic constipation.MethodsA two‐centered, prospective trial has been conducted between 2019 and 2022. SNM was applied continuously at individually set stimulation intensity. Evaluation of clinical outcomes was conducted at 3, 6, and 12 months after surgery based on the developed questionnaires and quality of life analysis (KINDLR). Primary outcome was assessed based on predefined variables of fecal incontinence and defecation frequency.Key ResultsFifteen patients enrolled in the study and underwent SNM (median age 8.0 years (range 4–17 years)): eight patients were diagnosed with Hirschsprung's disease (53%). Improvement of defecation frequency was seen in 8/15 participants (53%) and an improvement of fecal incontinence in 9/12 patients (75%). We observed stable outcome after 1 year of treatment. Surgical revision was necessary in one patient after electrode breakage. Urinary incontinence was observed as singular side effect of treatment in two patients (13%), which was manageable with the reduction of stimulation intensity.ConclusionsSNM shows promising clinical results in children and adolescents presenting with chronic constipation refractory to conservative therapy. Indications for patients with enteral neuropathies deserve further confirmation.

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Noninvasive Sacral Neuromodulation in Children and Adolescents: A Case-Control Study of Patients With Chronic Refractory Constipation

Cited by 5 publications

References 24 publications

A Narrative Review of Patient-Reported Outcome Measures and Their Application in Recent Pediatric Surgical Research: Advancing Knowledge and Offering New Perspectives to the Field

A Narrative Review of Patient-Reported Outcome Measures and Their Application in Recent Pediatric Surgical Research: Advancing Knowledge and Offering New Perspectives to the Field

Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents – study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique

Sacral neuromodulation in children and adolescents with defecation disorders

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