Randomized clinical trial of sacral nerve stimulation for refractory constipation

Zerbib, Frank; Siproudhis, L.; Germain, C.; Mion, François; Coffin, Benoït; Vitton, Véronique; Bouyssou-Cellier, C; Chêne, Geneviève; Simón, Miguel Ángel; Denost, Quentin; Lepicard, P; Pa, Lehur; Meurette, G.; Wyart, Vincent; Kubis, Caroline; Roman, Sabine; Damon, Henri; Barth, X.; Leroi, A.-M.; Bridoux, Valérie; Gourcerol, Guillaume; Castel, Benjamin; Gorbatchef, Caroline; Sidaner, Anne Le; Mathonnet, M.; Lesavre, Nathalie; Orsoni, P; Brochard, Charlène; Desfourneaux, Véronique

doi:10.1002/bjs.10326

Cited by 72 publications

(77 citation statements)

References 24 publications

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“…Recent randomized double-blind crossover studies have shown no difference between active and sham stimulations [17, 19]. In both studies, 30–60% of patients had a positive response during sham stimulation, suggestive of either lasting effects of sensory stimulation beyond washout period between sham and active treatment (2–3 weeks) or high placebo effects of this treatment.…”

Section: Discussionmentioning

confidence: 90%

Long-term outcome of sacral neuromodulation for chronic refractory constipation

et al. 2017

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PurposeSacral neuromodulation has been reported as a treatment for severe idiopathic constipation. This study aimed to evaluate the long-term effects of sacral neuromodulation by following patients who participated in a prospective, open-label, multicentre study up to 5 years.MethodsPatients were followed up at 1, 3, 6, 12, 24, 36, 48 and 60 months. Symptoms and quality of life were assessed using bowel diary, the Cleveland Clinic constipation score and the Short Form-36 quality-of-life scale.ResultsSixty-two patients (7 male, median age 40 years) underwent test stimulation, and 45 proceeded to permanent implantation. Twenty-seven patients exited the study (7 withdrawn consent, 7 loss of efficacy, 6 site-specific reasons, 4 withdrew other reasons, 2 lost to follow-up, 1 prior to follow-up). Eighteen patients (29%) attended 60-month follow-up. In 10 patients who submitted bowel diary, their improvement of symptoms was sustained: the number of defecations per week (4.1 ± 3.7 vs 8.1 ± 3.4, mean ± standard deviation, p < 0.001, baseline vs 60 months) and sensation of incomplete emptying (0.8 ± 0.3 vs 0.2 ± 0.1, p = 0.002). In 14 patients (23%) with Cleveland Clinic constipation score, improvement was sustained at 60 months [17.9 ± 4.4 (baseline) to 10.4 ± 4.1, p < 0.001]. Some 103 device-related adverse events were reported in 27 (61%).ConclusionBenefit from sacral neuromodulation in the long-term was observed in a small minority of patients with intractable constipation. The results should be interpreted with caution given the high dropout and complication rate during the follow-up period.

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Section: Discussionmentioning

confidence: 90%

Long-term outcome of sacral neuromodulation for chronic refractory constipation

et al. 2017

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“…Early studies on SNM for functional constipation were encouraging with both subjective and objective evidence of a positive treatment effect . However, two double‐blinded, placebo‐controlled studies have failed to show any significant change in their primary endpoint . Furthermore, in a consecutive follow‐up study by Dinning et al the explantation rate of 92%, mostly due to a lack of treatment effect, was extremely high .…”

Section: Discussionmentioning

confidence: 99%

Sacral nerve modulation for irritable bowel syndrome: A randomized, double‐blinded, placebo‐controlled crossover study

Fassov

Lundby

Laurberg

et al. 2019

Neurogastroenterology Motil

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Background Irritable bowel syndrome (IBS) is among the most common gastrointestinal disorders, and a substantial proportion of patients have an insufficient response to treatment. In a single‐blinded study, sacral nerve modulation (SNM) significantly reduced symptoms of IBS. The aim of the present double‐blinded, randomized, placebo‐controlled study was to evaluate the effect of SNM for IBS. Methods We included patients with diarrhea‐predominant or mixed IBS and a minimum baseline IBS‐specific symptom score of 40 points (Gastrointestinal Symptom Rating Scale‐IBS version). Patients underwent a 6‐week period of SNM. In the first 4 weeks, the patients were randomized 1:1 to have the neurostimulator set subsensory or OFF for 2 weeks and then the opposite for another 2 weeks. Patients and investigators were blinded to settings. In the remaining 2 weeks, the stimulation was set suprasensory. IBS‐specific symptoms and quality of life were assessed with validated questionnaires and bowel diaries. Key Results Twenty‐one patients were randomized and eligible for analysis. The IBS‐specific symptom score was reduced with borderline significance during stimulation (subsensory‐OFF median change −1 (−26, 9), OFF‐subsensory median change 8 (−11, 36); P = 0.0572). Pain was significantly reduced during stimulation (subsensory‐OFF median change −1.5 (−4, 1), OFF‐subsensory median change 1 (−4, 3); P = 0.0188), along with the number of daily bowel movements (subsensory‐OFF median change 0 (−1.8, 0.2), OFF‐subsensory median change 0.2 (−0.5, 1.1); P = 0.0373). The median placebo effect was 14% (0, 55). Conclusion and Inferences Sacral nerve modulation for IBS seems promising but should be considered experimental until larger multicenter studies have been performed.

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“…However, it is important to recognize that although SNS has become an established treatment option for adults with refractory fecal incontinence, evidence for its use for adults with constipation is less clear . In fact, two recent randomized crossover studies did not find SNS to be more effective than sham stimulation for adults with refractory constipation . In children, fecal incontinence often occurs secondary to poorly controlled constipation and is commonly used as a primary outcome to define treatment success in studies of pediatric constipation .…”

Section: Discussionmentioning

confidence: 99%

“…Over the past two decades, experience with the use of SNS to treat adults with constipation and fecal incontinence has grown, and SNS is now considered the first‐line surgical treatment for adults with fecal incontinence refractory to conventional treatment . However, recent studies have not shown SNS to be an effective treatment for adults with constipation . Experience with the use of SNS in children with constipation has been positive thus far but remains limited, and the long‐term outcomes of SNS treatment in children with constipation are not yet clearly understood .…”

Section: Introductionmentioning

confidence: 99%

Sacral nerve stimulation for constipation and fecal incontinence in children: Long‐term outcomes, patient benefit, and parent satisfaction

Koppen

Orsagh-Yentis

et al. 2017

Neurogastroenterology Motil

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Sacral nerve stimulation is a promising and durable treatment for children with refractory constipation, and appears particularly effective in decreasing fecal incontinence. Although a quarter of patients experienced complications requiring additional surgery, nearly all parents reported health-related benefit. Future studies to identify predictors of treatment response and complications are needed.

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Randomized clinical trial of sacral nerve stimulation for refractory constipation

Abstract: These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).

Cited by 72 publications

References 24 publications

Long-term outcome of sacral neuromodulation for chronic refractory constipation

Long-term outcome of sacral neuromodulation for chronic refractory constipation

Sacral nerve modulation for irritable bowel syndrome: A randomized, double‐blinded, placebo‐controlled crossover study

Sacral nerve stimulation for constipation and fecal incontinence in children: Long‐term outcomes, patient benefit, and parent satisfaction

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