A double‐blinded randomized multicentre study to investigate the effect of changes in stimulation parameters on sacral nerve stimulation for constipation

Thomas, G. P.; Duelund-Jakobsen, Jakob; Dudding, T. C.; Bradshaw, Elissa; Nicholls, R. J.; Alam, Ahsan; Emmanuel, Anton; Thin, Noel N.; Knowles, Charles H.; Laurberg, Søren; Vaizey, C. J.

doi:10.1111/codi.12982

Cited by 15 publications

(19 citation statements)

References 14 publications

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“…Over 18 clinical studies have used the PAC-SYM, since its validation in 1999: 14 of these have been reported since 2010. [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] Moreover, these trials have examined a range of interventions including sacral nerve stimulation, 20 lifestyle changes 19 and pharmacological agents. 6,11 Historically, a reduction in total score of 1 point or more has been used as the cut-off to define a positive response to treatment, 2 implying that this is a meaningful improvement.…”

Section: Introductionmentioning

confidence: 99%

The PAC‐SYM questionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

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SummaryBackgroundThe Patient Assessment of Constipation‐Symptoms (PAC‐SYM) questionnaire is frequently used in clinical trials of constipation. However, the threshold for reduction in total PAC‐SYM score used to define a clinical response on this 0‐4 point scale has not undergone formal appraisal, and its relationship with clinical benefit as perceived by patients has not been defined.AimTo determine the minimal important difference in PAC‐SYM score, and the optimum cut‐off value for defining responders.MethodsThe minimal important difference was estimated using data from six international phase 3/4, double‐blind, randomised controlled trials of prucalopride in patients with chronic constipation (NCT01147926, NCT01424228, NCT01116206, NCT00485940, NCT00483886, NCT00488137), with anchor‐ and distribution‐based approaches. Five appropriate patient‐reported outcomes were selected as anchors. In addition, receiver operating characteristics (ROC) curve analyses were used to investigate responder discrimination for each anchor.ResultsData from 2884 patients were included. Minimal important difference estimates ranged from –0.52 to –0.63 across the five anchors. Estimates were not affected by study location but were consistently lower for rectal symptoms than for abdominal and stool symptoms. Distribution‐based estimates were considerably lower than anchor‐based estimates. ROC curve analyses showed optimum cut‐off scores for discriminating responders to be similar to anchor‐based minimal important difference estimates.ConclusionsAnchor‐based methods gave consistent results for the minimal important difference, at approximately –0.6, and this value was close to the ROC‐determined optimal cut‐off scores for responder discrimination. This value could be considered in clinical practice. A slightly more conservative threshold (eg –0.75) could be used in clinical trials to reduce the placebo response rate.

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Section: Introductionmentioning

confidence: 99%

The PAC‐SYM questionnaire for chronic constipation: defining the minimal important difference

Yiannakou

Tack

Piessevaux

et al. 2017

Aliment Pharmacol Ther

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“…From these, only seven articles published between 2001 and 2015 contributed to the systematic review, providing data on outcomes in a total of 375 patients (range 21–117 patients per study) (Table . Specific exclusions after full‐text review (and after exclusion of non‐English language publications: n = 1) included nine studies where the population sample was confirmed to be less than 20 patients , one study which was a dual publication reporting a patient cohort that overlapped with another study and one study where results were combined for mixed indication s . Study follow up ranged from 20 to 51 months.…”

Section: Introductionmentioning

confidence: 99%

Surgery for constipation: systematic review and practice recommendations

et al. 2017

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Aim To assess the outcomes of sacral nerve stimulation in adults with chronic constipation.Method Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level.Results Seven articles were identified, providing data on outcomes in 375 patients. Length of procedures and length of stay was not reported. Data on harms were inconsistently reported and heterogeneous, making estimates of harm tentative and imprecise. Morbidity rates ranged between 13 and 34%, with overall device removal rate between 8 and 23%. Although inconsistently reported, pooled treatment success was typically 57-87% for patients receiving permanent implants, although there was significant variation between studies. Patient selection was inconsistently documented. No conclusions could be drawn regarding particular phenotypes that responded favourably or unfavourably to sacral nerve stimulation.Conclusion Evidence supporting sacral nerve stimulation is derived from poor quality studies. Three methodologically robust trials are have reported since this review and all have all urged greater caution.

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“…Indeed, some neuromodulation equipment has been reported for treatment of LUTS, constipation and faecal incontinence [12]. Electrical stimulation [13–18], magnetic stimulation [19–22] and interferential therapy [23, 24] are mainly used for modulation via the sacral nerve or tibial nerve. Although the precise mechanisms of neuromodulation are not yet known, activation of afferent nerves may lead to activation of efferent nerves in the pelvic organs, including the urinary bladder and colon [13, 14].…”

Section: Resultsmentioning

confidence: 99%

Impact of ao-dake-humi, Japanese traditional bamboo foot stimulator, on lower urinary tract symptoms, constipation and hypersensitivity to cold: a single-arm prospective pilot study

Minagawa

Saitou

Suzuki

et al. 2016

BMC Complement Altern Med

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Background Ao-dake-humi is a traditional Japanese bamboo foot stimulator consisting of a half-pipe-shaped step made of bamboo used to stimulate the foot by stepping on it, and is commonly used to promote general health among the elderly in Japan. However, its efficacy has not been reported in the scientific literature. This study was performed to investigate the role of ao-dake-humi focusing on lower urinary tract symptoms (LUTS), constipation, and hypersensitivity to cold (HC).MethodsParticipants with LUTS, constipation, or HC were enrolled in this study. Ao-dake-humi was used twice a day for 28 days. Before and 28 days after starting ao-dake-humi use, international prostate symptom score (IPSS), quality-of-life (QoL) score, and overactive bladder symptom score (OABSS) were measured to evaluate the efficacy of ao-dake-humi on LUTS. To evaluate the objective efficacy of ao-dake-humi on LUTS, a frequency-volume chart (FVC) was plotted in LUTS patients for 3 days. A visual analogue scale (VAS) was used to evaluate the efficacy of ao-dake-humi on constipation (VAS-constipation) and HC (VAS-HC) in the participants with constipation or HC.ResultsA total of 24 participants were enrolled in this study. Twenty-one participants had LUTS, 11 had constipation, and 17 participants had HC. IPSS, especially storage-subscore, QoL score and OABSS, decreased significantly after use of ao-dake-humi. The use of ao-dake-humi increased maximal bladder capacity, resulting in a significant decrease in urinary frequency as determined from the FVC. In accordance with the results of VAS-constipation and VAS-HC, both constipation and HC were significantly relieved after ao-dake-humi use.ConclusionThe results of this prospective pilot study indicated that ao-dake-humi is safe and has therapeutic efficacy in cases of LUTS, constipation and HC. The possibility of using ao-dake-humi as physical neuromodulation therapy was shown in the management of LUTS, constipation and HC.Trial registration UMIN000019333 (UMIN-CTR, Registered October-15-2015) retrospectively registered.

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A double‐blinded randomized multicentre study to investigate the effect of changes in stimulation parameters on sacral nerve stimulation for constipation

Abstract: Alteration of pulse width or frequency of stimulation had no significant effect on the outcome of SNS for constipation.

Cited by 15 publications

References 14 publications

The PAC‐SYM questionnaire for chronic constipation: defining the minimal important difference

The PAC‐SYM questionnaire for chronic constipation: defining the minimal important difference

Surgery for constipation: systematic review and practice recommendations

Impact of ao-dake-humi, Japanese traditional bamboo foot stimulator, on lower urinary tract symptoms, constipation and hypersensitivity to cold: a single-arm prospective pilot study

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