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Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.

Publication ,  Journal Article
Zyczynski, HM; Arya, LA; Lukacz, ES; Richter, HE; Rahn, DD; Sung, VW; Visco, AG; Shaffer, A; Jelovsek, JE; Rogers, R; Mazloomdoost, D ...
Published in: Female pelvic medicine & reconstructive surgery
December 2021

High-level evidence for second-line noninvasive treatments for fecal incontinence in women is limited. We present the rationale for and design of the NeuromOdulaTion for Accidental Bowel Leakage trial, a randomized controlled trial of percutaneous tibial nerve stimulation (PTNS) and validated sham stimulation in women with refractory accidental bowel leakage.The rationale and goals for a 2-part study with a run-in phase, use of a generic pulse generator for PTNS and sham stimulation, masking, participant inclusion, primary and secondary outcome measures, and adverse event collection are described. A superiority design will be used to compare change from baseline in St. Mark's score after 12 weekly stimulation sessions between PTNS and sham. Responders to initial treatment (PTNS or sham) will be assigned to scheduled or "as needed" intervention for up to 1 year. Secondary outcome measures include incontinence episodes and other bowel events recorded in a 14-day electronic bowel diary, general and condition-specific quality of life instruments, adaptive behavior, global impression of improvement, symptom control, and sexual function.Sample size calculations determined that 165 participants (110 PTNS and 55 sham) would provide 90% power to detect greater than or equal to 4-point difference between PTNS and sham in change from baseline in St. Mark's score at 12 weeks.The methods for the NeuromOdulaTion for Accidental Bowel Leakage trial will provide high-level evidence of the effectiveness and optimal maintenance therapy schedule of a low-cost PTNS protocol in community-dwelling women seeking second-line intervention for refractory accidental bowel leakage.

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Published In

Female pelvic medicine & reconstructive surgery

DOI

EISSN

2154-4212

ISSN

2151-8378

Publication Date

December 2021

Volume

27

Issue

12

Start / End Page

726 / 734

Related Subject Headings

  • Treatment Outcome
  • Transcutaneous Electric Nerve Stimulation
  • Tibial Nerve
  • Quality of Life
  • Humans
  • Female
  • Fecal Incontinence
  • 3215 Reproductive medicine
  • 3202 Clinical sciences
 

Citation

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Chicago
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Zyczynski, H. M., Arya, L. A., Lukacz, E. S., Richter, H. E., Rahn, D. D., Sung, V. W., … Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN), . (2021). Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. Female Pelvic Medicine & Reconstructive Surgery, 27(12), 726–734. https://doi.org/10.1097/spv.0000000000001050
Zyczynski, Halina M., Lily A. Arya, Emily S. Lukacz, Holly E. Richter, David D. Rahn, Vivian W. Sung, Anthony G. Visco, et al. “Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.Female Pelvic Medicine & Reconstructive Surgery 27, no. 12 (December 2021): 726–34. https://doi.org/10.1097/spv.0000000000001050.
Zyczynski HM, Arya LA, Lukacz ES, Richter HE, Rahn DD, Sung VW, et al. Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. Female pelvic medicine & reconstructive surgery. 2021 Dec;27(12):726–34.
Zyczynski, Halina M., et al. “Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study.Female Pelvic Medicine & Reconstructive Surgery, vol. 27, no. 12, Dec. 2021, pp. 726–34. Epmc, doi:10.1097/spv.0000000000001050.
Zyczynski HM, Arya LA, Lukacz ES, Richter HE, Rahn DD, Sung VW, Visco AG, Shaffer A, Jelovsek JE, Rogers R, Mazloomdoost D, Gantz MG, Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network (PFDN). Design of a Randomized Controlled Trial of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Refractory Fecal Incontinence in Women: The NeurOmodulaTion for Accidental Bowel Leakage Study. Female pelvic medicine & reconstructive surgery. 2021 Dec;27(12):726–734.

Published In

Female pelvic medicine & reconstructive surgery

DOI

EISSN

2154-4212

ISSN

2151-8378

Publication Date

December 2021

Volume

27

Issue

12

Start / End Page

726 / 734

Related Subject Headings

  • Treatment Outcome
  • Transcutaneous Electric Nerve Stimulation
  • Tibial Nerve
  • Quality of Life
  • Humans
  • Female
  • Fecal Incontinence
  • 3215 Reproductive medicine
  • 3202 Clinical sciences