NOTABLE

Neuromodulation for Accidental Bowel Leakage

The NOTABLE study is part of the PFDN portfolio of clinical studies aimed at providing insights into treatment of fecal incontinence (FI) also referred to as accidental bowel leakage (ABL).

This RCT will compare ABL symptom severity and other functional and quality of life outcomes in women with refractory fecal incontinence assigned 2:1 to PTNS and sham intervention. Study definition of refractory ABL includes women with persistent symptoms despite first-line treatments (pelvic muscle exercises and lack of response or tolerance to constipating medication).

The study design has 2 parts with a 4-week “Run-In” to confirm that prior to randomization, subjects have a minimum symptom burden.

The Run-In phase entails completion of a bowel diary and standardized education on behavioral interventions that may lead to better bowel control.

In Part 1, eligible subjects will be randomized 2:1 to PTNS or sham stimulation sessions.

In part 2. responders (≥ 4 point reduction from baseline in St Mark’s Score will be randomized to two maintenance strategies for 9 months: a fixed schedule, or a symptom driven treatment schedule based upon response to the PGSC.

Subjects who are deemed responders will be receive stimulation sessions through 1 year after enrollment.

Some of the questions that the investigators hope to answer by conducting this study include:

Whether 12 weekly sessions of PTNS are better than sham in reducing symptoms of accidental bowel leakage, urgency before bowel movements, and other possibly related medical problems such as urinary tract infections.
For those who improve with PTNS, whether the benefits are sustained for up to 1 year and whether a rigid schedule or “on demand” schedule of maintenance treatments after the first 12 weeks results in differences in symptom control and satisfaction at 1 year.

The PFDN designed an electronic bowel diary for this study. Enrolled smartphone owners in the Run-In phase will be recruited to a supplementary randomized crossover study comparing the eDiary and the paper diary. Study aims include:

Determining app performance, ease of use, and preference of diary modalities
Correlation and reproducibility of eDiary data when compared to a paper diary
Determining predictors to electronic bowel diary adherence, completion rates and preference as well as likelihood of diary “fatigue” with 7-day vs. 14-day diary

The study began in February 2018 and enrolled for 1-2 years.

Data for the primary aim will be analyzed from the first 147 subjects who complete Part 1. Based upon the results, the study will be terminated for lack of difference or the sham arm will be discontinued.

STUDY RESULTS SUMMARY

Andy UU, et al. Dietary Intake and Symptom Severity in Women with Fecal Incontinence. Int Urogynecol J. 2024 May.

Meyer I, et al. Correlation Between Mobile-Application Electronic Bowel Diary and Validated Questionnaires in Women with Fecal Incontinence. Int Urogynecol J. 2024 Mar.

Luchristt D, et al. Characteristics associated with subjective and objective measures of treatment success in women undergoing percutaneous tibial nerve stimulation vs sham for accidental bowel leakage. Int Urogynecol J. 2023 Aug.

Zyczynski HM, et al. Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial. Am J Gastroenterol. 2022 Apr.

Zyczynski HM, 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 Med Reconstr Surg. 2021 Dec.

Zyczynski HM, et al. Performance, acceptability, and validation of a phone application bowel diary. Neurourol Urodyn. 2020 Nov.

ClinicalTrials.gov

ClinicalTrials.Gov ID: NCT03278613