N
eurOmodulaTion for Accidental Bowel LE
akage (NOTABLE)
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:
1. 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.
2. 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:
1) determining app performance, ease of use, and preference of diary
modalities
2) correlation and reproducibility of ediary data when compared to a paper
diary.
1. 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 is expected to start in February 2018 and
will enroll 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.
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Read more about this study at clinicaltrials.gov.
STUDY RESULTS:
Zyczynski, Halina M. MD; Arya, Lily A. MD†; Lukacz, Emily S. MD‡; Richter, Holly E. PhD, MD; Rahn, David D. MD∥; Sung, Vivian W. MD; Visco, Anthony G. MD; Shaffer, Amanda MSN; Jelovsek, J. Eric MD, MMEd, MSDS; Rogers, Rebecca MD; Mazloomdoost, Donna MD; Gantz, Marie G. PhD for the 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, Female Pelvic Medicine & Reconstructive Surgery: May 4, 2021 - Volume Publish Ahead of Print - Issue - doi: 10.1097/SPV.0000000000001050
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