Sacrale neuromodulatie
Uitgangsvraag
Wat is de aanbevolen strategie voor het toepassen van sacrale neuromodulatie om patiënten met fecale incontinentie te behandelen?
Aanbeveling
Overweeg sacrale neuromodulatie aan te bieden bij patiënten met fecale incontinentie, indien met niet-chirurgische maatregelen onvoldoende behandelresultaat is bereikt.
Overwegingen
Balans tussen gewenste en ongewenste effecten
Er is een literatuuronderzoek verricht om te achterhalen of sacrale neuromodulatie effectief is bij patiënten met fecale incontinentie. In aanvulling op de studies uit de internationale richtlijn fecale incontinentie is in dit literatuuronderzoek één extra studie opgenomen naar de effectiviteit van SNM bij patiënten met fecale incontinentie. De cruciale uitkomstmaten waren de frequentie en ernst van fecale incontinentie en (ziekte-specifieke) kwaliteit van leven. Secondaire uitkomstmaten waren het risico op herinterventie en heroperatie. In de studies leidt sacrale neuromodulatie tot minder frequente fecale incontinentie (GRADE: zeer laag). De ernst van fecale incontinentie (gemeten door de CCF-FI score) wordt mogelijk verminderd (GRADE: laag). Daarnaast had sacrale neuromodulatie een positief effect op de ziekte-specifieke kwaliteit van leven (gemeten door de FIQoL score) bij patiënten met fecale incontinentie, specifiek na 3 tot 12 maanden (GRADE: moderate). De overall bewijskracht van de onderzoeken is echter zeer laag. Er is geen bewijs gevonden over het effect van sacrale neuromodulatie op het risico op herinterventie en heroperatie. Verder zijn er geen goede voorspellers en parameters voor selectie van patiënten voor SNM. Doorgaans wordt de behandeling in twee stappen aangeboden: eerst een proefbehandeling met een externe stimulator en bij goede klinische respons wordt er een definitieve stimulator geimplanteerd.
Kwaliteit van bewijs
De overall kwaliteit van bewijs is zeer laag. Dit betekent dat we zeer onzeker zijn over het gevonden geschatte effect van de cruciale uitkomstmaten.
Er is afgewaardeerd vanwege ernstige:
- Risk of Bias: methodologische beperkingen van de studies.
- Imprecisie: onnauwkeurigheid vanwege het niet bereiken van de optimale steekproefgrootte.
- Indirectheid: door het ontbreken van een duidelijke controlegroep.
Waarden en voorkeuren van patiënten (en eventueel hun naasten/verzorgers)
Gewenste effecten
Sacrale neuromodulatie kan zorgen voor minder episoden van fecale incontinentie, wat een positief effect kan hebben op de kwaliteit van leven.
Ongewenste effecten
De beschreven nadelen van sacrale neuromodulatie zijn pijn en kans op infectie.
Kostenaspecten
De UEG-richtlijn heeft drie studies geïncludeerd die de incrementele kosteneffectiviteit ratio’s (ICER) beschrijven. Leroi (2011) rapporteert een ICER van €185.160 voor SNM na 45 maanden follow-up. Voor patiënten met een structurele deficiëntie van de anale sfincter werd een ICER gerapporteerd van €22,195 (Brosa, 2008) en €28.285 per QALY (Indinnimeao, 2010). Voor patiënten met een structureel intacte anale sfincter werd een ICER van €16.181 gerapporteerd (Brosa, 2008) en €38.662 per QALY (Indinnimeao, 2010). De kosteneffectiviteit die daarin gerapporteerd staat lijkt te verschillen per patiëntenpopulatie en in sommige gevallen overschrijden de kosten de Nederlands vastgestelde threshold van 80.000 euro per QALY.
Gelijkheid ((health) equity/equitable)
De interventie leidt niet tot een afname van gezondheidsgelijkheid, want sacrale neuromodulatie bij patiënten met indicatie fecale incontinentie wordt volledig vergoed uit het basispakket.
Aanvaardbaarheid
Ethische aanvaardbaarheid
De interventie lijkt aanvaardbaar voor de betrokkenen. Er zijn geen ethische bezwaren.
Duurzaamheid
Bij de interventie spelen de volgende duurzaamheidsaspecten een rol: mogelijk CO2 afdruk door device gebruik en operatieve procedures.
Haalbaarheid
De interventie is haalbaar. De interventie is over het algemeen al standaardzorg in de praktijk.
Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies
Eindoordeel:
Zwakke aanbeveling voor (Doen).
Onderbouwing
Sacral nerve modulation (SNM) is an accepted therapeutic option in the treatment of fecal (and/ or) urinary incontinence. In this guideline, the evidence of SNM effectivity is shown applied to the Dutch health care organization.
Summary of Findings
Population: Adult patients with fecal incontinence
Intervention: sacral neuromodulation on
|
Outcome Timeframe |
Study results and measurements |
Absolute effect estimates |
Certainty of the evidence (Quality of evidence) |
Summary |
|
sacral neuromodulation sacral neuromodulation on off (sham) |
||||
|
Frequency of FI-episodes per week at 2 weeks, 3 months, 32 weeks, 12 months*
|
Measured by: Diary scale Follow-up 2 weeks, 3 months, 32 weeks, 12 months |
Mean number of FI episodes per week at 2 weeks: Vaizey (2000), MD -6 (95%CI -11.59 to -0.41) Mean number of FI episodes per week at 3 months: Tjandra (2008), MD -5.20 (95%CI-9.15 to -1.25) Kalke (2015), MD -7.40 (95%CI-12.04 to -2.76) Mean number of FI episodes per week at 32 weeks: Mean number of FI episodes per week at 12 months: Tjandra (2008) MD -6.30 (95%CI -10.34 to -2.26) |
Very low Due to very serious risk of bias, Due to serious indirectness1 |
The evidence is very uncertain about the effect of sacral neuromodulation on frequency of FI episodes per week (at 2 weeks, 3 months, 32 weeks and 12 months follow-up), when compared with sham in adult patients with FI (Vaizey 2000; Tjandra 2008; Kalke 2015; Vollebregt 2024)** |
|
Severity of FI: CCF-FI score at 3 months, 12 months*
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Based on data from 134 participants in 2 studies Follow-up 3 months, 12 months |
Mean difference in points CCF-FI score at 3 months: Tjandra (2008), MD-11 (95%CI -11.60 to -10.40)
Mean difference in points CCF-FI score at 12 months: |
Low Due to serious risk of bias, Due to serious indirectness2 |
Sacral neuromodulation may improve severity of FI-episodes (at 3 weeks, at 12 months), when compared with placebo in adult patients with FI (Tjandra 2008, Kalke 2015) *** |
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Severity of FI: St Marks score at not specified follow up period
|
Based on data from 43 participants in 1 study Follow-up not specified |
Adjusted mean difference in St Marks continence score at no specified follow-up: |
Very low Due to very serious risk of bias, Due to serious imprecision3 |
The evidence is very uncertain about the effect of sacral neuromodulation on severity of FI-episodes (at no specified follow up period) when compared with placebo in adult patients with FI. (Vollebregt 2024) |
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Disease-specific quality of life (FIQoL) score at 3 months, 12 months4*
|
Based on data from 120 participants in 1 study Follow up 3 to 12 months |
Mean difference in FIQoL score at 3 months: Mean difference in FIQoL score at 12 months: |
Moderate Due to serious risk of bias4 |
Use of sacral neuromodulation at 3 to 12 months may result in little difference on disease-specific quality of life when compared with placebo in adult patients with FI. (Tjandra 2008) |
|
Disease-specific quality of life (FIQoL) score at no specified follow-up period |
Based on data from 43 participants in 1 study Follow up not specified |
Mean difference in FIQoL score at no specified follow-up period: |
Very low Due to very serious risk of bias, Due to serious imprecision3 |
The evidence is very uncertain about the effect of sacral neuromodulation on disease specific quality of life at no specified follow up when compared with placebo in adult patients with FI. (Vollebregt 2024) |
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Generic quality of life: EQ-5D-5L score at no specified follow-up period
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Based on data from 46 participants in 1 study Follow up regardless of period |
Adjusted mean difference in summary index value at no specified follow-up period: |
Very low Due to very serious risk of bias, Due to serious imprecision3 |
The evidence is very uncertain about the effect of sacral neuromodulation on general quality of life at no specified follow up period when compared with placebo in adult patients with FI. (Vollebregt 2024) |
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Generic quality of life: Short Form Health Survey (SF)-36 score |
- |
- |
No GRADE (no evidence was found)
|
No conclusions could be drawn about the effect of sacral neuromodulation on the SF-36 score, compared with placebo or conservative treatment in adult patients with FI, because of the absence of data. |
|
Re-operation rate |
- |
- |
No GRADE (no evidence was found)
|
No conclusions could be drawn about the effect of sacral neuromodulation on the re-operation rate, compared with placebo or conservative treatment in adult patients with FI, because of the absence of data. |
|
Re-intervention rate |
- |
- |
No GRADE (no evidence was found)
|
No conclusions could be drawn about the effect of sacral neuromodulation on the re-operation rate, compared with placebo or conservative treatment in adult patients with FI, because of the absence of data. |
*These outcome measures and conclusions are adapted from the UEG-guideline and supplemented with our included study Vollebregt (2024).
**Leroi 2005; Sorenson 2010 were included in the UEG guideline but MD’s were not mentioned, as in Leroi (2005), the median was reported with no statistically significant differences between groups. Sorenson (2010) was a conference abstract which did not report any events.
*** Leroi 2005; Sorenson 2010 were included in the UEG-guideline but MD’s were not mentioned, as in Leroi 2005 the median was reported with no statistically significant differences and Sorenson (2010) and Vaizey 2000 did not report/measure severity of FI.
**** Mean differences in Vollebregt (2024) were adjusted for period and sex (fixed effects) and random effects for centre and participant. Direction of difference: SNM-sham; hence negative differences indicate lower scores with SNM versus sham
*****Faecal Incontinence Quality of Life (FIQoL)
1. Risk of Bias: very serious. Trials stopping earlier than scheduled, resulting in potential for overestimating benefits, Incomplete data and/or large loss to follow up, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate concealment of allocation during randomization process, resulting in potential for selection bias; Indirectness: serious. Means and SD's were estimated from a figure; a true sham group was lacking (conservative treatment group in the study of Tjandra, 2008).
2. Risk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate concealment of allocation during randomization process, resulting in potential for selection bias. Indirectness: serious. Means and SD's were estimated from a figure; a true sham group was lacking conservative treatment group in the study of Tjandra, 2008).
3. Risk of Bias: very serious. Trials stopping earlier than scheduled, resulting in potential for overestimating benefits, Incomplete data and/or large loss to follow up, Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate concealment of allocation during randomization process, resulting in potential for selection bias; Imprecision: serious. Low number of participants, wide confidence intervals
4. Risk of Bias: serious. Inadequate/lack of blinding of participants and personnel, resulting in potential for performance bias, Inadequate concealment of allocation during randomization process, resulting in potential for selection bias. Means and SDs were estimated from a figure; a true sham group was lacking conservative treatment group in the study of Tjandra (2008).
Description of studies
We included one systematic review from the UEG/ESCP/ESNM/ESPCG guideline (Assmann, 2021) in our analysis. The updated literature search identified one new study (Vollebregt, 2024) that was added to the analysis of the literature. For details of the studies included in the UEG/ESCP/ESNM/ESPCG guideline, please refer to the supporting documents of that guideline.
SNM ON versus SNM OFF
The UEG/ESCP/ESNM/ESPCG guideline included one systematic review (Thaha, 2015) which examined the effects of SNM versus no SNM in patients with fecal incontinence. Thaha (2015) included five randomized controlled and cross-over trials. Thaha (2015) did not perform a meta-analysis due to heterogeneity of the data and trial designs. Vaizey (2000), Leroi (2005), Sorenson (2010) and Khalke (2015) were cross-over studies in which participants were assigned to an ‘SNM ON’ or ‘SNM OFF’ group. A total of 59 patients were included in these four studies. Thaha (2015) furthermore included Tjandra (2008), in which the effectiveness of SNM was compared to optimal conservative treatment (pelvic floor exercises, bulking agents) in 120 participants.
Vollebregt (2024) performed a multicenter, randomized, double-blind, crossover trial at nine UK sites and one in Ireland, to determine the clinical efficacy of sub-sensory chronic low voltage electrical SNM using implantable device in adults, compared to sham. Adult patients (>18 years) with FI in whom conservative, non-surgical, treatment had failed were included. Furthermore, they met the Rome III and ICI definitions of FI (involuntary loss of fecal material which is not a consequence of acute diarrheal illness) with severity of minimally eight FI urgency episodes in a 4-week screening period. This cross-over design used two intervention periods (ON-OFF or OFF-ON) of 16 weeks duration (from week 0 to 16 and from week 16 to 32). Outcome measurements were collected in weeks 12 to 16 and 28 to 32. From week 32 the study used a cohort design, and patients were allowed to choose intervention based on their preferences. Therefore, results after week 32 are not included in our analysis. The number of required patients (n=90) was not met, and the trial was terminated earlier, due to COVID-19 pandemic. From the 39 included patients, only 16 had complete information on the primary outcome during both cross-over periods. Patients were lost to follow-up due to patient withdrawal, problems of eligibility or not completing the primary outcome. Analysis followed the modified ITT principle and there was no imputation of missing data other than for a sensitivity analysis of the primary outcome.
Important study characteristics and results of the new studies are summarized in Table 2. The assessment of the risk of bias is summarized in the risk of bias tables (under the tab ‘Evidence tabellen’).
Table 2. Characteristics of included study
|
Study |
Participants |
Comparison |
Follow-up |
Outcome measures |
Comments |
Risk of bias (per outcome measure)* |
|
Vollebregt, 2024 |
N at baseline (N=39) Control (arm 2): n=7 *Baseline table of number of participants at baseline (n=39) Age (mean, SD) Intervention (n=17): 55.9y (14.1) Control (n=22): 58.2y (11.8)
Sex M,(%1) Intervention (n=17): 1/17 (6%) Control: 2/22 (9%)
Duration of faecal incontinence symptoms (mean, SD years) Intervention (n=17): 9.5y (4.8)
*Baseline symptoms (n=33, Table 3) Intervention(n=13) : 5.1 (3.4)
*Baseline questionnaire score (n=39, Table 4) Assessment of Overactive Bladder symptoms short form (OAB-q SF) (mean, SD)
|
Intervention: chronic, subsensory (low amplitude) stimulation of a mixed sacral nerve (usually S3) using a commercially available surgically implant pulse generator)
Control: identical implant but turned off. |
Cross over with 2 x 16 weeks periods with a follow up to 58 weeks. -19 participants completed the follow up fase with n=2 loss to follow up |
1. Frequency of FI episodes
Reduction in total FI events per week (at week 32) (Mean, SD) Intervention (n=16): 2.3 (2.8) Control (n=16): 3.0 (3.7)
MD: -0.7 (95%CI -1.5 to 0.0, p=0.06)
Severity of FI symptoms Original St. marks questionnaire score (regardless of period)
Adjusted MD2 -0.15 (95%CI: -2.55 to 1.81)
Disease-specific and generic Quality of life3:
Faecal Incontinence Quality of Life (FIQoL)
Coping behavior mean score Intervention (n=19) 2.1 (0.6)
Depression/self-perception mean score
Embarrassment mean score
EQ-5D-5L Adjusted MD -0.02 (95%CI: -1.10 to 0.05) Adjusted MD 1.58 (95%CI: -3.72 to 6.88) |
Award funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 14/144/08). |
Frequency of FI episodes High risk of bias
Severity of FI symptoms High risk of bias
Disease specific and generic Quality of life High risk of bias
|
1. Percentages calculated excluding missing data.
2. Mean difference adjusted for period and sex (fixed effects) and random effects for centre and participant.
3. There were no issues with convergence of the regression models for the secondary outcomes. Analysis included therefore all available data (not only participants with data in both cross-over period).
*For further details, see risk of bias table in the appendix
Results
Frequency of FI episodes
The UEG/ESCP/ESNM/ESPCG guideline described 5 studies that reported on FI episodes per week. The recurrence of FI-episodes was not reported in any of the included studies. See the SoF table for the results and conclusions.
Vollebregt (2024) reported the reduction in total FI events per week and found a mean difference of -0.7 (95%CI -1.5 to 0.0) between groups. Data was only reported for participants with data in both cross-over periods (n=16).
Severity of FI symptoms
The UEG guideline included 3 studies that reported FI severity using change in fecal incontinence score (CCF-FI score). See SoF table for the results and conclusions.
Vollebregt (2024), reported St. Marks questionnaire score and the analysis was done with data in both cross-over periods. The study reported an adjusted mean difference of -0.15 (95%CI: -2.55 to 1.81).
Disease-specific and Generic Quality of life
The UEG guideline included two studies that reported on quality of life (Tjandra, 2008; Leroi, 2005). However, only Tjandra (2008) was included in the analysis, using the FI QOL score. The study of Leroi (2005) was not included since QoL since participants were allowed to choose their preferred stimulation mode during the follow-up period.
Vollebregt (2024) reported both disease specific (FIQoL) and generic (EQ5D-5L) questionnaires.
Disease specific Quality of Life
FI QOL score.
Tjandra (2008) reported mean difference on all four domains (Lifestyle, Coping behavior, Depression/self-perception, Embarrassment) in favour of SNM at both 3 and 12 months. See SoF table for further results and conclusions.
Vollebregt (2024), reported QoL using FI QOL with an undefined follow-up period and the analysis was done with data in both cross-over periods. The adjusted mean difference (MD) was -0.11 (95%CI: -0.38 to 0.16) for the Lifestyle score, 0.06 (95%CI: -0.24 to 0.36) for the Coping behavior score, -0.01 (-95%CI: -0.26 to 0.24) for the Depression/self-perception score, -0.05 (95%CI: -0.29 to 0.19) for Embarrassment score.
Generic Quality of life
Vollebregt (2024) reported 1) an adjusted MD of -0.02 (95%CI: -1.10 to 0.05), for the summary index and 2) an adjusted MD of 1.58 (95%CI: -3.72 to 6.88) for the EQ-VAS score.
Re-operation rate
No studies reported on the re-operation rate.
Re-intervention rate
No studies reported on the re-intervention rate.
A systematic review of the literature was performed to answer the following question:
What are the favorable and unfavorable effects of sacral neuromodulation on outcomes in patients with fecal incontinence (FI), compared with no sacral neuromodulation?
Table 1. PICO
| Patients | Adult patients (>18 years) with fecal incontinence |
| Intervention | Sacral neuromodulation |
| Control | No sacral neuromodulation or sham or conservative treatment |
| Outcomes |
1. Frequency of FI episodes:
2. Severity of FI symptoms:
3. Quality of life (QoL):
4. Re-operation/re-intervention rate: number of patients undergoing repeated interventions |
| Other selection criteria | Study design: systematic reviews (searched in at least two databases, detailed search strategy, risk of bias assessment and results of individual studies available) and randomized controlled trials Published after October 2020 (update of the literature search of the international UEG/ESCP/ESNM/ESPCG guideline) Full-text English publication available |
Relevant outcome measures
The guideline panel considered frequency of FI episodes, severity of FI episodes, and quality of life as critical outcome measures for decision making. The risk of re-operation/re-intervention is seen as an important outcome measure for decision making.
The guideline panel used definitions of outcome measurements following the UEG/ESCP/ESNM/ESPCG guideline (see below). However, for future updates the guideline panel refers to the recently published core outcome set (COS) for adults with fecal incontinence (Assmann, 2025).
The guideline panel defined the outcome measures as follows:
1. Frequency of FI episodes, measured by:
- number of FI episodes per week
- number of FI episodes per 4 weeks
2. Severity of FI symptoms, measured by:
a. St. Marks incontinence score or Vaizey questionnaire.
St. Marks consists of questions on types of anal incontinence and its impact on daily life. The Vaizey questionnaire is a patient-reported adaptation of the St. Mark’s score. Score for both questionnaire ranges from 0 to 24 with higher score indicating complete incontinence (Roos, 2009).
b. https://meetinstrumentenzorg.nl/wp-content/uploads/instrumenten/Wexner-score-form.pdfnce and the influences on lifestyle. Score ranges from 0 to 20 with higher score indicating less favorable outcomes (Bols, 2011).
3. Quality of life (QoL):
Disease-specific QoL, measured by:
a. https://meetinstrumentenzorg.nl/instrumenten/fecal-incontinence-quality-of-life-scale/t of FI. The score ranges from 4 to 16, with higher scores indicating favourable outcomes (Bols, 2011).
Generic QoL, measured by:
b. https://www.brandeis.edu/roybal/docs/SF-36_website_PDF.pdffrom 0-100 with higher scores indicating less disability.
c. https://link.springer.com/rwe/10.1007/978-0-387-78665-0_5scale (EQ-VAS). The EQ-VAS records the subject’s perceptions of their own current overall health status with scores ranging from 0 to 100 (best imaginable health). The questionnaire is a self-reported description of the subject’s current health in 5 dimensions, with which utilities can be calculated (Gusi, 2010).
The guideline panel did not define the outcome measurements ‘re-operation/re-intervention rate’ but used the definitions provided in the studies.
The guideline panel defined the following thresholds as a minimal clinically (patient) important difference (MID) for each outcome measure:
1. Frequency of FI episodes:
a. Number of FI episodes per week: mean difference of >0.5 or a 50% decrease in number of FI episodes.
b. Number of FI episodes per 4 weeks: mean difference of >0.5 or a 50% decrease in number of FI episodes.
2. Severity of FI symptoms:
a. St Marks/Vaizey questionnaire: mean difference of -3 points (Bols, 2011).
b. Wexner (CCF-FI) score: mean difference of -2 points (Bols, 2011).
3. Disease-specific quality of life:
a. Faecal Incontinence Quality of Life (FIQoL) questionnaire: >0.4 point difference.
4. Generic Quality of life:
a. Short Form Health Survey (SF-36): mean difference of >0.7 score points (from baseline).
b. EQ-5D score: mean difference: > 0.03 points for the index score and >6 points for VAS.
Search and select (Methods)
We used and updated the literature search strategy of the UEG/ESCP/ESNM/ESPCG Guideline for the diagnosis and treatment of faecal incontinence (Assmann, 2022). For the UEG/ESCP/ESNM/ESPCG guideline, a literature search was conducted in Medline (via OVID), Embase (OVID) and Cochrane databases until October, 2020. During the current adaptation of this guideline, a systematic literature search was performed by a medical information specialist using the following bibliographic databases: Embase.com and Ovid/Medline. Both databases were searched from October 1, 2020, to March 25, 2025 for systematic reviews and RCTs. Systematic searches were completed using a combination of controlled vocabulary and natural language keywords. The overall search strategy was derived from the following primary search concepts: (1) fecal incontinence; (2) sacral neuromodulation. Duplicates were removed using EndNote software. After deduplication a total of 144 records were imported for title/abstract screening. The detailed search strategy is listed under the tab ‘Literature search strategy’. More information about the methodology of the international guideline Faecal incontinence can be found in the Methods section of the guideline (supporting documents) on the UEG website.
Three studies were initially selected based on title and abstract screening. After reading the full text, two studies were excluded (see the exclusion table under the tab ‘Evidence tabellen’), and one study was included.
- Assmann SL, Kimman ML, Breukink SO, Keszthelyi D. The Burden of Fecal Incontinence: Evaluating the Societal Impact in Terms of Economic Burden and Health-Related Quality of Life. Neurogastroenterol Motil. 2025 Sep;37(9):e70036. doi: 10.1111/nmo.70036. Epub 2025 Apr 2. PMID: 40173293; PMCID: PMC12351359.
- Assmann SL, Keszthelyi D, Kleijnen J, Anastasiou F, Bradshaw E, Brannigan AE, Carrington EV, Chiarioni G, Ebben LDA, Gladman MA, Maeda Y, Melenhorst J, Milito G, Muris JWM, Orhalmi J, Pohl D, Tillotson Y, Rydningen M, Svagzdys S, Vaizey CJ, Breukink SO. Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG/ESCP/ESNM/ESPCG collaboration. United European Gastroenterol J. 2022 Apr;10(3):251-286. doi: 10.1002/ueg2.12213. Epub 2022 Mar 18. Erratum in: United European Gastroenterol J. 2022 Jul;10(6):606-607. doi: 10.1002/ueg2.12258. PMID: 35303758; PMCID: PMC9004250.
- Assmann SL, Keszthelyi D, Kimman ML, Breukink SO; Faecal Incontinence COS working group. Faecal incontinence core outcome set: an international Delphi consensus exercise among patients, health-care professionals, and researchers. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):769-778. doi: 10.1016/S2468-1253(25)00013-5. Epub 2025 Jun 11. PMID: 40516560.
- Bols E, Hendriks E, Berghmans B, Baeten C, de Bie R. A critical evaluation of the Vaizey Score, Wexner Score and the Fecal Incontinence Quality of Life Scale for clinical use in patients with faecal incontinence. Abstr p 380. [Internet]. Available from: https://www.ics.org/Abstracts/Publish/106/000380.pdf?utm_source=chatgpt.com10). The EQ-5D Health-Related Quality of Life Questionnaire. In: Preedy, V.R., Watson, R.R. (eds) Handbook of Disease Burdens and Quality of Life Measures. Springer, New York, NY. https://doi.org/10.1007/978-0-387-78665-0_5Topic H, Peleikis HG, Jongen J. Sacral nerve modulation for fecal incontinence: results of a prospective single‐center randomized crossover study. Dis Colon Rectum. 2015;58(2):235–40. 65.
- Leroi A‐M, Parc Y, Lehur P‐A, Mion F, Barth X, Rullier E, et al. Efficacy of sacral nerve stimulation for fecal incontinence: results of a multicenter double‐blind crossover study. Ann Surg. 2005;242(5):662–9. 66.
- Roos AM, Sultan AH, Thakar R. St. Mark's incontinence score for assessment of anal incontinence following obstetric anal sphincter injuries (OASIS). Int Urogynecol J Pelvic Floor Dysfunct. 2009 Apr;20(4):407-10. doi: 10.1007/s00192-008-0784-7. Epub 2008 Dec 12. PMID: 19082774.
- Sorensen M, Thomsen F. Sacral nerve stimulation increases rectal sensitivity in patients with faecal incontinence: results of a randomised double‐blinded crossover study (Abstract number 437). In: Proceedings of the joint meeting of the International Continence Society (ICS) and the International Urogynecological Association, 2010, Aug 23‐27, Toronto, Canada [Internet]; 2010. Available from: https://www.cochranelibrary.com/central/doi/10.1002/ central/CN‐00766350/full 67.
- Thaha MA, Abukar AA, Thin NN, Ramsanahie A, Knowles CH. Sacral nerve stimulation for faecal incontinence and constipation in adults. Cochrane Database Syst Rev. 2015;8.
- Tjandra JJ, Chan MKY, Yeh CH, Murray‐Green C. Sacral nerve stimulation is more effective than optimal medical therapy for severe fecal incontinence: a randomized, controlled study. Dis Colon Rectum. 2008;51(5):494–502.
- Vaizey CJ, Kamm MA, Roy AJ, Nicholls RJ. Double‐blind crossover study of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2000;43(3):298–302. 68.
- Vollebregt PF, Goh YL, Chan CL, Dudding T, Furlong P, Hamdy S, Haviland J, Hooper R, Jones J, McAlees E, Norton C, O’Connell PR, Scott SM, Stevens N, Tubby K, Worthen S, Wong YL, Knowles CH. Clinical effectiveness of subsensory sacral neuromodulation in adults with faecal incontinence: the SUBSoNIC crossover RCT and mechanistic study. Southampton (UK): National Institute for Health and Care Research; 2024 Nov. PMID: 39652698.
Risk of Bias tables
|
Study reference
(first author, publication year) |
Was the allocation sequence adequately generated?
Definitely yes Probably yes Probably no Definitely no |
Was the allocation adequately concealed?
Definitely yes Probably yes Probably no Definitely no |
Blinding: Was knowledge of the allocated interventions adequately prevented? Were patients blinded? Were healthcare providers blinded? Were data collectors blinded? Were outcome assessors blinded? Were data analysts blinded?
Definitely yes Probably yes Probably no Definitely no |
Was loss to follow-up (missing outcome data) infrequent?
Definitely yes Probably yes Probably no Definitely no |
Are reports of the study free of selective outcome reporting?
Definitely yes Probably yes Probably no Definitely no |
Was the study apparently free of other problems that could put it at a risk of bias? Definitely yes Probably yes Probably no Definitely no |
Overall risk of bias If applicable/necessary, per outcome measure
LOW Some concerns HIGH
|
|
Vollebregt, 2024 |
Definitely yes;
Reason: randomization performed at time of surgery using an online system from Pragmatic Clinical Trials Unit at QMUL. Randomisation was stratified by sex and centre with block sizes of four. |
Definitely yes;
Reason: online randomization list was generated by an independent statistician to ensure allocation concealment. Opaque, sealed envelopes were used and opened by an independent researcher.
Randomization was done prior to surgery, but it could also be delayed until the initial programming. Alternatively emergency randomization was performed by an unblinded member of the coordinating team. |
Definitely yes;
Reason: research team, statisticians, surgeons and participants were blinded.
Members of the trial management group, clinicians involved in programming stimulation settings were not blinded. |
Probably no;
Reason: Loss to follow-up was not infrequent. This was due to COVID (lock down and delays in follow up). Furthermore, one patient two patients had received no treatment (SNM device switched off) when they should have received treatment. The modified ITT principle was followed, including all participants according to randomized allocation and with available outcome data. There was no imputation of data, other than for the sensitivity analysis. Sensitivity analysis was used to assess the effect of incomplete paper diary. |
Probably no;
Reason: Original plans to derive measures of social and physical activity from the geospatial data were discarded as the data were shown to be unreliable |
Definitely no;
Reason: The study was terminated earlier due COVID, and therefore severely underpowered (90 participants were needed but final analysis was performed on 16 or 39 participants).
Fidelity of data capture; failure to recognise deficiencies od data capture meant no corrective actions were taken. |
HIGH Reduction in total FI episodes
Severity
Quality of life |
Table of excluded studies
|
Reference |
Reason for exclusion |
|
Jayne DG, Williams AE, Corrigan N, Croft J, Pullan A, Napp V, Kelly R, Meads D, Vargas-Palacios A, Martin A, Hulme C, Brown SR, Nugent K, Lodge J, Protheroe D, Maslekar S, Clarke A, Nisar P, Brown JM. Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT. Health Technol Assess. 2021 Mar;25(18):1-96. doi: 10.3310/hta25180. PMID: 33752794; PMCID: PMC8020198.
|
Wrong intervention (FENIX) versus comparison (SNM) |
|
Wang X, Chen JD. Therapeutic potential and mechanisms of sacral nerve stimulation for gastrointestinal diseases. J Transl Int Med. 2023 Jul 5;11(2):115-127. doi: 10.2478/jtim-2023-0086. PMID: 37408571; PMCID: PMC10318922. |
This systematic review also looks into other bowel diseases and methods is an expert opinion-based mini review. |
Beoordelingsdatum en geldigheid
Publicatiedatum : 06-11-2026
Beoordeeld op geldigheid : 06-11-2026
Algemene gegevens
Verenso heeft een verklaring van geen bezwaar afgegeven.
Samenstelling werkgroep
Voor het ontwikkelen van de richtlijnmodule is in 2024 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met fecale incontinentie.
Werkgroep
- Prof. dr. D. (Daniël) Keszthelyi, MDL-arts, Maastricht UMC+, voorzitter werkgroep (NVMDL)
- Dr. T.J. (Tze) Lam (NVMDL), MDL-arts, Rijnstate (NVMDL)
- Dr. L.A. (Laurens) van der Waaij, MDL-arts, Martini Ziekenhuis (NVMDL)
- Drs. B.J.T. (Bertram) Haarhuis, MDL-arts, Bernhoven (NVMDL)
- Dr. S. (Stephanie) Breukink, chirurg, Maastricht UMC+ (NVvH)
- Dr. C.I.M. (Coen) Baeten, chirurg, MSB Gouda (NVvH)
- Drs. F.J. (Froukje) Hoogenboom, chirurg, UMC Groninigen (NVvH)
- Dr. P (Paul) van Houten, specialist ouderengeneeskunde, AMR zorgnetwerk Noord Holland Flevoland; docent ouderengeneeskunde, AMC Amsterdam (Verenso)
- Dr. D.A. (Daniëlle) van Reijn, bekkenfysiotherapeut, Bekkenfysiotherapie Baarn (NVFB/KNGF)
- H.A.C. (Caroline) Hagenaars, bekkenfysiotherapeut, Bekkenfysiotherapie Hagenaars (NVFB/KNGF)
- Drs. E.A.M. (Gidia) Jacobs, gezondheidszorgpsycholoog en seksuoloog, Proctoskliniek te Bilthoven/Amsterdam/Rotterdam en CenSeRe te Voorschoten (NIP/NVVS)
- K.C.J. (Kim) de Kleijn, stomaverpleegkundige, Sint Jans Gasthuis (V&VN)
- C.W.L. (Tine) van den Bos, Stichting Bekkenbodem4All (Stichting Bekkenbodem4All)
Klankbordgroep
- Dr. M.K. (Marian) Kleinpenning-Engberts, gynaecoloog, Isala (NVOG)
- Dr. L.P.W. (Bart) Witte, uroloog, Isala (NVU)
- BSc, RD. J.H.M. (Jenny) Brouns, Maastricht UMC+, diëtist (NVD)
- Drs. D.N. (Danielle) van der Horst, senior projectmanager (Crohn & Colitis NL)
- Dr. W.L.J. (Walter) Devillé, patiëntonderzoeker (Parkinson Vereniging)
- Prof. dr. J.W.M. (Jean) Muris, huisarts (NHG)
- M. (Monica) de Heide, coördinator/ uitvoerend secretaris (Stichting Bekkenbodem4All)
- M.E. (Michelle) Hoogeveen (MDL-fonds), beleidsadviseur
- Drs. D.D. (Dyana) Loehr, voorlichter (Prikkelbare Darm Syndroom Belangenorganisatie)
Met ondersteuning van
- Dr. E. (Ekaterina) Baranova-van Dorp, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- P.G. (Phylisha) Bloemen - van Heemskerken, MSc, junior-adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- E. (Esther) van der Bijl, medisch informatiespecialist, Kennisinstituut van de Federatie Medisch Specialisten
Belangenverklaringen
Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten via secretariaat@kennisinstituut.nl.
Gemelde (neven)functies en belangen werkgroepleden
|
Naam |
Hoofdfunctie |
Nevenwerkzaamheden |
Persoonlijke financiële belangen |
Persoonlijke relaties |
Extern gefinancierd onderzoek |
Intellectuele belangen en reputatie |
Overige belangen |
Datum |
Restrictie |
|
Bertram Haarhuis |
MDL-arts Bernhoven |
Geen |
Geen |
Geen |
Geen |
Geen |
Geen |
27-09-2024 |
|
|
Caroline Hagenaars |
Bekkenfysiotherapeute Bekkenfysiotherapie Hagenaars, praktijkhouder en bekkenfysiotherapeute 4 dagen per week. |
Bekkenfysiotherapeute Amphia ziekenhuis Breda, bekkenbodemcentrum, in dienst werkzaam als bekkenfysiotherapeute 4 uur per week. Gastdocent Avans+ master bekkenfysiotherapie, incidenteel werkzaam op oproepbasis. |
Geen |
Geen |
Geen |
Geen |
Geen |
10-09-2024 |
|
|
Daniël Keszthelyi (Voorzitter) |
Maag-darm-leverarts en hoofd afdeling maag-darm-leverziekten, Maastricht UMC+ |
* Hoogleraar maag-darm-leverziekten, Universiteit Maastricht (onbetaald) * Associate editor, UEG Journal (betaald, betaling naar werkgever) * Media Editor, Neurogastroenterology and Motility (betaald, betaling naar werkgever) * Voorzitter, commissie Neurogastroenterologie en motoriek, NVMDL (onbetaald) * Voorzitter, sectie Neurogastroenterologie en motoroiek, NVGE (onbetaald) * Lid wetenschappelijk adviesraad, MLDS (onbetaald) * Lid, medische adviesraad, Prikkelbare Darmsyndroom Belangenorganisatie
|
Geen |
Geen |
* ZonMw - Nortriptyline bij functionele dyspepsie - Projectleider * ZonMw - Online hynptherapie bij prikkelbare darmsyndroom - Projectleider * ZonMw - Anale plug bij fecale incontinentie - Projectleider * ESM smartphone applicatie bij behandeling PDS - Projectleider * ERC (Horizon Europe) - Vagale zenuwstimulatie bij PDS - Projectleider * Horizon 2020 - Comorbiditeiten bij PDS - Geen projectleider * Rome Foundation - fMRI voor de studie van viscerale pijn - Projectleider * Allergan - ESM app voor de studie van linacltide - Projectleider * Grunenthal - Validatie van ESM app bij PDS - Projectleider * UEG - Europese richtlijn bij fecale incontinentie - Projectleider * UEG - Europese richtlijn bij buikklachten na colorectale chirugie - Geen projectleider |
Geen |
Geen |
21-09-2023 |
|
|
Danielle van Reijn |
Bekkenfysiotherapeut eigenaar |
Docent SOMT University of Pelvic Floor Physical therapy Senior researcher Proctos Kliniek
wetenschap LUMC/Proctoskliniek Docentschap opleiding Bekkenfysiotherapie |
Geen |
Geen |
1 jaar geleden webinar gegeven voor firma Novuquare tav studieresultaten promotieonderzoek. geen vacatie ontvangen |
Door bij te dragen aan deze richtlijn zal mijn expertise als bekkenfysiotherapeut gespecialiseerd in het achterste compartiment vergroot worden.
door mee te werken aan deze richtlijn geeft dit meer onderbouwing voor de evidentie in ons vakgebied |
Nee
1,5 jaar geleden een webinar gegeven over mijn studie promotieonderzoek voor firma Novuqare. Het meetinstrument wat gebruikt is in deze studie (niet gefinancierd) is de Maple. Niet gefinancierd op 10 april 2025 geef ik een nascholing voor continentieverpleegkundigen wat georganiseerd wordt door firma Coloplast. Geen belang. Onkostenvergoeding reis |
15-10-2024 |
|
|
Froukje Hoogenboom |
Chirurg UMCG |
- |
Geen |
Geen |
INSPIRE: Takeda - Registratiestudie gebruik Darvadstrcocel bij Crohnse perianale fistels - Geen projectleider |
Geen |
Geen |
16-10-2024 |
|
|
Gidia Jacobs |
Proctoskliniek te Bilthoven/Amsterdam/Rotterdam en CenSeRe te Voorschoten |
Docent bij UOI en docent bij RINO en docent bij SOMT Lid Tuchtrechtcommissie NVVS |
2 dagen in Loondienst bij de Proctoskliniek als gezondheidszorgpsycholoog-seksuoloog NVVS 3 dagen vrijgevestigd werk bij Centrum voor psychische, relationele en seksuele gezondheid te Voorschoten. |
Neen als het om financieel gewin gaat ; ja, als het gaat om wetenschappelijkeinzichten. |
Heb ik niet aan deelgenomen |
Er zijn weinig psychologen-seksuologen die zich in dit gebied verdiepen. Maar als er al wetenschappelijk iets te zeggen is over de eventuele positieve bijdragen van een pycholoog-seksuoloog in de zorg voor pt met FI, dan is dan kan ik me niet goed voorstellen dat dat een 'product' is dat je zou kunnen of willen 'vermarkten'. |
Neen |
11-09-2024 |
|
|
Kim de Kleijn |
Stoma-/ coloncareverpleegkundige bij Sint Jans Gasthuis |
Innovatie team Welland Community & innovatie V&VN stoma
Stoma innovatie team Nederland Europese stoma adviesraad Innovatie & communicatie team stoma V&VN Stoma vakgroep Brabant & Limburg Europese adviesraad Convatec Stoma vakgroep |
Geen |
Geen |
Geen |
Geen |
Geen |
18-10-2024 |
|
|
Laurens van der Waaij |
MDL arts in het Martini Ziekenhuis |
ik werk, net als mijn hele vakgroep, 1 dag per 2 weken als ZZP-er in de Keizerkliniek (ZBC). Hier verricht ik met name endoscopieen. |
Ik heb geen persoonlijke financiele belangen |
Neen |
Neen, ik verricht momenteel geen wetenschappelijk onderzoek |
Ik heb geen intellectueel belang/reputatie bij deze richtlijn |
Ik heb geen andere mogelijk conflicterende belangen |
15-10-2024 |
|
|
Stephanie Breukink |
chirurg dr Breukink werkgever MUMC |
Geen |
Geen |
Geen |
Geen |
Laatste auteur van internationale richtlijn fecale incontinentie |
Geen |
19-09-2024 |
|
|
Tine van den Bos |
Voorzitter Stichting Bekkenbodem4All |
Bekkenfysiotherapeut zzp 2 dgn/wk |
Geen |
Geen |
Geen |
Geen |
Geen |
18-09-2024 |
|
|
Tze Lam |
MDL-arts Rijnstate |
Geen |
Geen |
Geen |
deelgenomen aan studie van anale plug |
Geen |
Geen |
4-10-2024 |
|
|
Paul Houten |
Specialist Ouderengeneeskunde, AMR zorgnetwerk Noord Holland Flevoland. 8 uur per week, betaald |
Gespreksleider Leren van data programma, Amsterdam UMC Vice voorzitter cie Goed Gebruik Hulpmiddelen Zonmw |
Geen |
Geen |
Geen |
Als expert bij Zorg voor Beter (Vilans) kan het zijn dat bepaalde informatie van belang kan zijn voor de website. |
Een paar maal per jaar heb ik (onbezoldigd) overleg met mensen van Essity met betrekking tot verdere ontwikkeling slim incontinentie materiaal |
28-01-2025 |
|
|
Ekaterina Baranova |
Adviseur, Kennisinstituut van de Federatie Medisch Specialisten |
Geen |
Geen |
Geen |
Geen |
Geen |
Geen |
05-10-2026 |
|
|
Phylisha van Heemskerken |
Junior adviseur, Kennisinstituut van de Federatie Medisch Specialisten |
Geen |
Geen |
Geen |
Geen |
Geen |
Geen |
05-10-2026 |
|
Gemelde (neven)functies en belangen klankbordgroepleden
|
Naam
|
Hoofdfunctie |
Nevenwerkzaamheden |
Persoonlijke Financiële Belangen |
Persoonlijke Relaties |
Extern gefinancierd onderzoek |
Intell. belangen en reputatie |
Overige belangen |
Datum |
Akkoord Ondertekening |
|
Bart Witte |
Uroloog, Isala Klinieken |
* Secretaris Werkgroep Functionele en Reconstructieve Urologie NVU (onbetaald) * Lid Wetenschappelijke Commissie NVU (onbetaald) * Lid Dutch Urological Research Organisation NVU (onbetaald) |
Geen |
Geen |
* ZonMw - RELIEF studie (wat is de optimale katheterduur bij een acute urineretentie?) - Projectleider * Isala I&W fonds - Stepped vs Matched Care in Overactive Bladder Therapy - Projectleider * Isala I&W fonds - Ehealth in care for women with recurrent urinary tract infections - Geen projectleider |
Geen |
Geen |
20-11-204 |
Ja |
|
Jenny Brouns |
Diëtist Maastricht UMC+ met specifieke deskundigheid MDL |
Geen |
Geen |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
18-10-2024 |
Ja |
|
Marian Kleinpenning-Engberts |
Isala, urogynaecoloog |
Tutor voor Coloplast/Altis procedure bij stress urine incontinentie |
Behoudens bovengenoemde nevenwerkzaamheden geen financieel belang bij de uitkomst van deze richtlijn |
Geen |
Via het Innovatie en Wetenschapsfonds van Isala heb ik een grant gekregen om onderzoek te kunnen doen naar de behandeling van stress urine incontinentie, maar dit bijt niet met de uitkomst/valt buiten de scope van deze richtlijn |
Geen |
Geen |
26-08-2024 |
Ja |
|
Danielle van der Horst |
Projectmanager Crohn & Colitis NL |
Geen |
Geen |
Geen |
Geen |
Geen |
Geen |
18-3-2025 |
|
|
Jean Muris |
hoogleraar huisartsgeneeskunde, Universiteit Maastricht |
Geen |
Geen |
Geen |
Geen |
Geen |
Geen |
3-04-2025 |
|
|
Walter Devillé |
Parkinson Vereniging |
patientonderzoeker |
Geen |
Geen |
Geen |
Geen |
Geen |
29-4-2025 |
Ja |
|
Michelle Hoogeveen |
Beleidsmedewerker MDL Fonds |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
9-7-2025 |
Ja |
|
Monica de Heide |
Coördinator Stuchting Bekkenbodem4all |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
28-7-2025 |
Ja |
|
Dyana Loehr |
Vrijwilliger voorlichting bij Prikkelbare Darm Syndroom |
24 uur per week betaald werk als projectleider / senior Communicatieadviseur (niet relevant hiervoor) |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
Niet van toepassing |
15-4-2026 |
Ja |
Inbreng patiëntenperspectief
De werkgroep besteedde aandacht aan het patiëntenperspectief door het uitnodigen van patiëntenorganisaties en Patiëntenfederatie Nederland voor de schriftelijke knelpuntenanalyse en het afvaardigen van patiëntvertegenwoordigers in de werkgroep (Stichting Bekkenbodem4All) en klankbordgroep (Prikkelbare Darm Syndroom Belangenorganisatie, Crohn & Colitis NL, Parkinson Vereniging, MDL Fonds). De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen. De conceptrichtlijn is tevens voor commentaar voorgelegd aan patiëntenorganisaties(Stichting Bekkenbodem4All, Prikkelbare Darm Syndroom Belangenorganisatie, Crohn & Colitis NL, Parkinson Vereniging, MDL Fonds) en Patiëntenfederatie Nederland. De eventueel aangeleverde commentaren zijn bekeken en verwerkt.
Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz
Bij de richtlijnmodule voerde de werkgroep conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uit om te beoordelen of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling is de richtlijnmodule op verschillende domeinen getoetst (zie het stroomschema bij Werkwijze).
|
Module |
Uitkomst raming |
Toelichting |
|
Submodule Sarcrale neuromodulatie |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling(en) niet breed toepasbaar zijn (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
Werkwijze
Voor meer details over de gebruikte richtlijnmethodologie verwijzen wij u naar de Werkwijze. Relevante informatie voor de ontwikkeling/herziening van deze richtlijnmodule is hieronder weergegeven.
Zoekverantwoording
Zoekstrategie - 25 maart 2025
Embase.com
|
No. |
Query |
Results |
|
#1 |
'feces incontinence'/exp OR encopresis:ti,ab,kw OR encopresia:ti,ab,kw OR encopresy:ti,ab,kw OR 'incontinentia alvi':ti,ab,kw OR (((bowel* OR rectum OR rectal* OR anal OR anus) NEAR/4 (leak OR leakage OR leaks OR leaking OR seep OR seepage OR seeps OR seeping OR accident* OR escap* OR uncontrolled OR trickl* OR 'lack of control' OR 'no control' OR 'out of control' OR 'not voluntary' OR involuntary OR control* OR incontinen*)):ti,ab,kw) OR (((unable OR inabilit* OR abilit* OR able) NEAR/3 control* NEAR/3 (faeces OR faecal* OR feces OR fecal* OR stool* OR rectum OR rectal* OR bowel* OR anal* OR anus OR diarrh* OR soiling)):ti,ab,kw) OR (((feces OR faeces OR fecal* OR faecal* OR stool OR stools OR defecat* OR soiling) NEAR/4 (leak OR leakage OR leaks OR leaking OR seep OR seepage OR seeps OR seeping OR accident* OR escap* OR escaping OR uncontrolled OR trickl* OR 'not voluntary' OR involuntary OR control* OR incontinen*)):ti,ab,kw) OR (((diarrh* OR pseudodiarrh* OR 'pseudo diarrh*') NEAR/4 (leak OR leakage OR leaks OR leaking OR seep OR seepage OR seeps OR seeping OR accident* OR escap* OR uncontrolled OR trickl* OR 'not voluntary' OR involuntary OR control*)):ti,ab,kw) OR (((bowel* OR rectum OR rectal* OR defecat*) NEAR/4 (disorder* OR malfunction* OR dysfunction* OR evacuat* OR obstruct* OR block*)):ti,ab,kw) OR (('pelvic floor' NEAR/3 (dysfunct* OR disorder* OR syndrome*)):ti,ab,kw) |
91449 |
|
#2 |
'sacral nerve stimulation'/exp OR 'sacral nerve stimulator'/exp OR ('tibial nerve'/exp AND 'nerve stimulation'/exp) OR (((sacral OR tibial OR 's3') NEAR/2 (nerve* OR root) NEAR/2 (modulat* OR stimulat*)):ti,ab,kw) OR (((sacral OR tibial OR 's3') NEAR/2 (neuromodulat* OR 'neuro modulat*' OR neurostimulat* OR 'neuro stimulat*' OR 'auto augment*' OR autoaugment)):ti,ab,kw) OR ((sacral NEAR/3 (modulation OR stimulation)):ti,ab,kw) OR snm:ti,ab,kw OR sns:ti,ab,kw |
18017 |
|
#3 |
#1 AND #2 NOT ('conference abstract'/it OR 'editorial'/it OR 'letter'/it OR 'note'/it) NOT (('animal'/exp OR 'animal experiment'/exp OR 'animal model'/exp OR 'nonhuman'/exp) NOT 'human'/exp) NOT (('adolescent'/exp OR 'child'/exp OR adolescent*:ti,ab,kw OR child*:ti,ab,kw OR schoolchild*:ti,ab,kw OR infant*:ti,ab,kw OR girl*:ti,ab,kw OR boy*:ti,ab,kw OR teen:ti,ab,kw OR teens:ti,ab,kw OR teenager*:ti,ab,kw OR youth*:ti,ab,kw OR pediatr*:ti,ab,kw OR paediatr*:ti,ab,kw OR puber*:ti,ab,kw) NOT ('adult'/exp OR 'aged'/exp OR 'middle aged'/exp OR adult*:ti,ab,kw OR man:ti,ab,kw OR men:ti,ab,kw OR woman:ti,ab,kw OR women:ti,ab,kw)) |
1251 |
|
#4 |
#3 AND [01-10-2020]/sd |
334 |
|
#5 |
'meta analysis'/exp OR 'systematic review'/exp OR 'scoping review'/exp OR 'rapid review'/exp OR 'umbrella review'/exp OR 'cochrane database of systematic reviews'/jt OR 'network meta-analysis'/exp OR 'networkmeta analy*':ti,ab,kw OR 'networkmetaanaly*':ti,ab,kw OR metaanaly*:ti,ab,kw OR 'meta analy*':ti,ab,kw OR metanaly*:ti,ab,kw OR prisma:ti,ab,kw OR prospero:ti,ab,kw OR metaanali*:ti,ab,kw OR 'meta anali*':ti,ab,kw OR metanali*:ti,ab,kw OR (((systemati* OR scoping OR umbrella OR 'structured literature') NEAR/3 (review* OR overview*)):ti,ab,kw) OR (((structured OR systemic*) NEAR/3 (review* OR overview* OR synth*) NEAR/3 literature):ti,ab,kw) OR ((systemic* NEAR/1 review*):ti,ab,kw) OR (((systemati* OR literature OR database* OR 'data base*') NEAR/10 search*):ti,ab,kw) OR (((structured OR comprehensive* OR systemic*) NEAR/3 search*):ti,ab,kw) OR (((literature NEAR/3 (review* OR overview*)):ti,ab,kw) AND (search*:ti,ab,kw OR database*:ti,ab,kw OR 'data base*':ti,ab,kw)) OR (('data extraction*':ti,ab,kw OR 'data source*':ti,ab,kw) AND ('study selection*':ti,ab,kw OR 'studies selection*':ti,ab,kw)) OR ('search strateg*':ti,ab,kw AND 'selection criteria*':ti,ab,kw) OR ('data source*':ti,ab,kw AND 'data synth*':ti,ab,kw) OR medline*:ti,ab,kw OR pubmed*:ti,ab,kw OR 'pub med*':ti,ab,kw OR embase:ti,ab,kw OR cochrane*:ti,ab,kw OR (((critical* OR rapid*) NEAR/2 (review* OR overview* OR synth*)):ti) OR ((((critical* OR rapid*) NEAR/3 (review* OR overview* OR synth*)):ab) AND (search*:ab OR database*:ab OR 'data base*':ab)) OR metasynth*:ti,ab,kw OR 'meta synth*':ti,ab,kw OR 'review* of review*':ti,ab,kw |
1093584 |
|
#6 |
'clinical trial'/exp OR 'randomization'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp OR 'placebo'/exp OR 'prospective study'/exp OR rct:ab,ti OR random*:ab,ti OR 'single blind':ab,ti OR 'randomized controlled trial'/exp OR placebo*:ab,ti |
4236944 |
|
#7 |
#4 AND #5 |
47 |
|
#8 |
#4 AND #6 NOT #7 |
84 |
|
#9 |
#7 OR #8 |
131 |
Ovid/Medline
|
# |
Searches |
Results |
|
1 |
exp Fecal Incontinence/ or (encopresis or encopresia or encopresy or 'incontinentia alvi').ti,ab,kf. or ((bowel* or rectum or rectal* or anal or anus) adj4 (leak or leakage or leaks or leaking or seep or seepage or seeps or seeping or accident* or escap* or uncontrolled or trickl* or "lack of control" or "no control" or "out of control" or "not voluntary" or involuntary or control* or incontinen*)).ti,ab,kf. or ((unable or inabilit* or abilit* or able) adj3 control* adj3 (faeces or faecal* or feces or fecal* or stool* or rectum or rectal* or bowel* or anal* or anus or diarrh* or soiling)).ti,ab,kf. or ((feces or faeces or fecal* or faecal* or stool or stools or defecat* or soiling) adj4 (leak or leakage or leaks or leaking or seep or seepage or seeps or seeping or accident* or escap* or escaping or uncontrolled or trickl* or "not voluntary" or involuntary or control* or incontinen*)).ti,ab,kf. or ((diarrh* or pseudodiarrh* or 'pseudo diarrh*') adj4 (leak or leakage or leaks or leaking or seep or seepage or seeps or seeping or accident* or escap* or uncontrolled or trickl* or "not voluntary" or involuntary or control*)).ti,ab,kf. or ((bowel* or rectum or rectal* or defecat*) adj4 (disorder* or malfunction* or dysfunction* or evacuat* or obstruct* or block*)).ti,ab,kf. or ('pelvic floor' adj3 (dysfunct* or disorder* or syndrome*)).ti,ab,kf. |
56726 |
|
2 |
(exp Tibial Nerve/ and exp Electric Stimulation Therapy/) or ((sacral or tibial or "S3") adj2 (nerve* or root) adj2 (modulat* or stimulat*)).ti,ab,kf. or ((sacral or tibial or "S3") adj2 (neuromodulat* or 'neuro modulat*' or neurostimulat* or 'neuro stimulat*' or 'auto augment*' or autoaugment)).ti,ab,kf. or (sacral adj3 (modulation or stimulation)).ti,ab,kf. or snm.ti,ab,kf. or sns.ti,ab,kf. |
10922 |
|
3 |
(1 and 2) not (comment/ or editorial/ or letter/) not ((exp animals/ or exp models, animal/) not humans/) not ((Adolescent/ or Child/ or Infant/ or adolescen*.ti,ab,kf. or child*.ti,ab,kf. or schoolchild*.ti,ab,kf. or infant*.ti,ab,kf. or girl*.ti,ab,kf. or boy*.ti,ab,kf. or teen.ti,ab,kf. or teens.ti,ab,kf. or teenager*.ti,ab,kf. or youth*.ti,ab,kf. or pediatr*.ti,ab,kf. or paediatr*.ti,ab,kf. or puber*.ti,ab,kf.) not (Adult/ or adult*.ti,ab,kf. or man.ti,ab,kf. or men.ti,ab,kf. or woman.ti,ab,kf. or women.ti,ab,kf.)) |
934 |
|
4 |
limit 3 to dt="20201001-20250325" |
200 |
|
5 |
exp Meta-Analysis/ or exp Network Meta-Analysis/ or exp Systematic Review/ or (networkmeta analy* or networkmetaanaly* or metaanaly* or meta analy* or metanaly* or prisma or prospero or metaanali* or meta anali* or metanali*).ti,ab,kf. or ((systemati* or scoping or umbrella or structured literature) adj3 (review* or overview*)).ti,ab,kf. or ((structured or systemic*) adj3 (review* or overview* or synth*) adj3 literature).ti,ab,kf. or (systemic* adj1 review*).ti,ab,kf. or ((systemati* or literature or database* or data base*) adj10 search*).ti,ab,kf. or ((structured or comprehensive* or systemic*) adj3 search*).ti,ab,kf. or ((literature adj3 (review* or overview*)) and (search* or database* or data base*)).ti,ab,kf. or ((data extraction* or data source*) and (study selection* or studies selection*)).ti,ab,kf. or (search strateg* and selection criteria*).ti,ab,kf. or (data source* and data synth*).ti,ab,kf. or (medline* or pubmed* or pub med* or embase or cochrane*).ti,ab,kf. or cochrane.jw. or ((critical* or rapid*) adj2 (review* or overview* or synth*)).ti. or (((critical* or rapid*) adj3 (review* or overview* or synth*)) and (search* or database* or data base*)).ab. or metasynth*.ti,ab,kf. or meta synth*.ti,ab,kf. |
819634 |
|
6 |
exp clinical trial/ or randomized controlled trial/ or exp clinical trials as topic/ or randomized controlled trials as topic/ or Random Allocation/ or Double-Blind Method/ or Single-Blind Method/ or (clinical trial, phase i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or controlled clinical trial or randomized controlled trial or multicenter study or clinical trial).pt. or random*.ti,ab. or (clinic* adj trial*).tw. or ((singl* or doubl* or treb* or tripl*) adj (blind$3 or mask$3)).tw. or Placebos/ or placebo*.tw. |
2868106 |
|
7 |
4 and 5 |
33 |
|
8 |
(4 and 6) not 7 |
34 |
|
9 |
7 or 8 |
67 |