Sacral Nerve Stimulation Fails to Offer Long-term Benefit in Patients with Slow-Transit Constipation

Vicki Patton, Peter Stewart, David Z. Lubowski, Ian J. Cook, Phil G. Dinning

Research output: Contribution to journalArticleResearchpeer-review

16 Citations (Scopus)

Abstract

BACKGROUND: Sacral nerve stimulation is proposed as a treatment for slow-transit constipation. However, in our randomized controlled trial we found no therapeutic benefit over sham stimulation. These patients have now been followed-up over a long-term period. OBJECTIVE: The purpose of this study was to assess the long-term efficacy of sacral nerve stimulation in patients with scintigraphically confirmed slow-transit constipation. DESIGN: This study was designed for long-term follow-up of patients after completion of a randomized controlled trial. SETTINGS: It was conducted at an academic tertiary public hospital in Sydney. PATIENTS: Adults with slow-transit constipation were included. MAIN OUTCOME MEASURES: At the 1-and 2-year postrandomized controlled trial, the primary treatment outcome measure was the proportion of patients who reported a feeling of complete evacuation on >2 days per week for ≥2 of 3 weeks during stool diary assessment. Secondary outcome was demonstration of improved colonic transit at 1 year. RESULTS: Fifty-three patients entered long-term follow-up, and 1 patient died. Patient dissatisfaction or serious adverse events resulted in 44 patients withdrawing from the study because of treatment failure by the end of the second year. At 1 and 2 years, 10 (OR = 18.8% (95% CI, 8.3% to 29.3%)) and 3 patients (OR = 5.7% (95% CI,-0.5% to 11.9%)) met the primary outcome measure. Colonic isotope retention at 72 hours did not differ between baseline (OR = 75.6% (95% CI, 65.7%-85.6%)) and 1-year follow-up (OR = 61.7% (95% CI, 47.8%-75.6%)). LIMITATIONS: This study only assessed patients with slow-transit constipation. CONCLUSIONS: In these patients with slow-transit constipation, sacral nerve stimulation was not an effective treatment.

Original languageEnglish
Pages (from-to)878-885
Number of pages8
JournalDiseases of the Colon and Rectum
Volume59
Issue number9
DOIs
Publication statusPublished - 1 Sep 2016
Externally publishedYes

Keywords

  • Sacral nerve stimulation
  • Slow transit constipation

Cite this

Patton, Vicki ; Stewart, Peter ; Lubowski, David Z. ; Cook, Ian J. ; Dinning, Phil G. / Sacral Nerve Stimulation Fails to Offer Long-term Benefit in Patients with Slow-Transit Constipation. In: Diseases of the Colon and Rectum. 2016 ; Vol. 59, No. 9. pp. 878-885.
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abstract = "BACKGROUND: Sacral nerve stimulation is proposed as a treatment for slow-transit constipation. However, in our randomized controlled trial we found no therapeutic benefit over sham stimulation. These patients have now been followed-up over a long-term period. OBJECTIVE: The purpose of this study was to assess the long-term efficacy of sacral nerve stimulation in patients with scintigraphically confirmed slow-transit constipation. DESIGN: This study was designed for long-term follow-up of patients after completion of a randomized controlled trial. SETTINGS: It was conducted at an academic tertiary public hospital in Sydney. PATIENTS: Adults with slow-transit constipation were included. MAIN OUTCOME MEASURES: At the 1-and 2-year postrandomized controlled trial, the primary treatment outcome measure was the proportion of patients who reported a feeling of complete evacuation on >2 days per week for ≥2 of 3 weeks during stool diary assessment. Secondary outcome was demonstration of improved colonic transit at 1 year. RESULTS: Fifty-three patients entered long-term follow-up, and 1 patient died. Patient dissatisfaction or serious adverse events resulted in 44 patients withdrawing from the study because of treatment failure by the end of the second year. At 1 and 2 years, 10 (OR = 18.8{\%} (95{\%} CI, 8.3{\%} to 29.3{\%})) and 3 patients (OR = 5.7{\%} (95{\%} CI,-0.5{\%} to 11.9{\%})) met the primary outcome measure. Colonic isotope retention at 72 hours did not differ between baseline (OR = 75.6{\%} (95{\%} CI, 65.7{\%}-85.6{\%})) and 1-year follow-up (OR = 61.7{\%} (95{\%} CI, 47.8{\%}-75.6{\%})). LIMITATIONS: This study only assessed patients with slow-transit constipation. CONCLUSIONS: In these patients with slow-transit constipation, sacral nerve stimulation was not an effective treatment.",
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Sacral Nerve Stimulation Fails to Offer Long-term Benefit in Patients with Slow-Transit Constipation. / Patton, Vicki; Stewart, Peter; Lubowski, David Z.; Cook, Ian J.; Dinning, Phil G.

In: Diseases of the Colon and Rectum, Vol. 59, No. 9, 01.09.2016, p. 878-885.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Sacral Nerve Stimulation Fails to Offer Long-term Benefit in Patients with Slow-Transit Constipation

AU - Patton, Vicki

AU - Stewart, Peter

AU - Lubowski, David Z.

AU - Cook, Ian J.

AU - Dinning, Phil G.

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N2 - BACKGROUND: Sacral nerve stimulation is proposed as a treatment for slow-transit constipation. However, in our randomized controlled trial we found no therapeutic benefit over sham stimulation. These patients have now been followed-up over a long-term period. OBJECTIVE: The purpose of this study was to assess the long-term efficacy of sacral nerve stimulation in patients with scintigraphically confirmed slow-transit constipation. DESIGN: This study was designed for long-term follow-up of patients after completion of a randomized controlled trial. SETTINGS: It was conducted at an academic tertiary public hospital in Sydney. PATIENTS: Adults with slow-transit constipation were included. MAIN OUTCOME MEASURES: At the 1-and 2-year postrandomized controlled trial, the primary treatment outcome measure was the proportion of patients who reported a feeling of complete evacuation on >2 days per week for ≥2 of 3 weeks during stool diary assessment. Secondary outcome was demonstration of improved colonic transit at 1 year. RESULTS: Fifty-three patients entered long-term follow-up, and 1 patient died. Patient dissatisfaction or serious adverse events resulted in 44 patients withdrawing from the study because of treatment failure by the end of the second year. At 1 and 2 years, 10 (OR = 18.8% (95% CI, 8.3% to 29.3%)) and 3 patients (OR = 5.7% (95% CI,-0.5% to 11.9%)) met the primary outcome measure. Colonic isotope retention at 72 hours did not differ between baseline (OR = 75.6% (95% CI, 65.7%-85.6%)) and 1-year follow-up (OR = 61.7% (95% CI, 47.8%-75.6%)). LIMITATIONS: This study only assessed patients with slow-transit constipation. CONCLUSIONS: In these patients with slow-transit constipation, sacral nerve stimulation was not an effective treatment.

AB - BACKGROUND: Sacral nerve stimulation is proposed as a treatment for slow-transit constipation. However, in our randomized controlled trial we found no therapeutic benefit over sham stimulation. These patients have now been followed-up over a long-term period. OBJECTIVE: The purpose of this study was to assess the long-term efficacy of sacral nerve stimulation in patients with scintigraphically confirmed slow-transit constipation. DESIGN: This study was designed for long-term follow-up of patients after completion of a randomized controlled trial. SETTINGS: It was conducted at an academic tertiary public hospital in Sydney. PATIENTS: Adults with slow-transit constipation were included. MAIN OUTCOME MEASURES: At the 1-and 2-year postrandomized controlled trial, the primary treatment outcome measure was the proportion of patients who reported a feeling of complete evacuation on >2 days per week for ≥2 of 3 weeks during stool diary assessment. Secondary outcome was demonstration of improved colonic transit at 1 year. RESULTS: Fifty-three patients entered long-term follow-up, and 1 patient died. Patient dissatisfaction or serious adverse events resulted in 44 patients withdrawing from the study because of treatment failure by the end of the second year. At 1 and 2 years, 10 (OR = 18.8% (95% CI, 8.3% to 29.3%)) and 3 patients (OR = 5.7% (95% CI,-0.5% to 11.9%)) met the primary outcome measure. Colonic isotope retention at 72 hours did not differ between baseline (OR = 75.6% (95% CI, 65.7%-85.6%)) and 1-year follow-up (OR = 61.7% (95% CI, 47.8%-75.6%)). LIMITATIONS: This study only assessed patients with slow-transit constipation. CONCLUSIONS: In these patients with slow-transit constipation, sacral nerve stimulation was not an effective treatment.

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KW - Slow transit constipation

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U2 - 10.1097/DCR.0000000000000653

DO - 10.1097/DCR.0000000000000653

M3 - Article

VL - 59

SP - 878

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SN - 0012-3706

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