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Sacral Neuromodulation and the Microbiome

NCT02833402 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-11-18

No results posted yet for this study

Summary

Sacral neuromodulation (SNM) which is approved as a treatment for men and women with urgency urinary incontinence (UUI), urgency frequency syndrome, urinary retention and anal incontinence, is a procedure designed to deliver electrical pulses to the sacral nerves, thereby influencing the bladder, sphincters, and pelvic floor. Although the success rates of this treatment are quite high, the precise mechanism of action of SNM in subjects with UUI remains unclear. Moreover, there are little data regarding specific patient characteristics that may serve as "predictors" for SNM success. Recent studies suggest that the bacterial community that lives in the urinary tract plays a role in the development and continuation of urinary symptoms. It is proposed that the urinary microbiome may change in women before and after SNM implantation and this study aims to describe these changes. Investigators in this study also hope to determine if differences in the urinary microbiome exist in women with a positive response to SNM treatment (responders) compared to those without symptom improvement (non-responders). This hypothesis will be tested by collecting urine samples as well as questionnaire and medical data from subjects with UUI that are already planning on undergoing SNM as part of clinical care before and after their SNM treatment.

Conditions

  • Urgency Urinary Incontinence

Interventions

DEVICE

InterStim Therapy

Sacral Neuromodulation, delivered by the InterStim® System, offers long-term control of bladder control and bowel control symptoms through modulation of the nerves that help control the pelvic floor and lower urinary tract.

Sponsors & Collaborators

Principal Investigators

  • Margaret Mueller, MD · Northwestern University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833402 on ClinicalTrials.gov