Sacral Neuromodulation and the Microbiome

NCT ID: NCT02833402

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-09-30

Brief 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.

Detailed Description

One in four women reports bothersome symptoms of a pelvic floor disorder with 16% reporting urinary incontinence (UI). Sacral neuromodulation (SNM) which is approved 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. SNM provides symptomatic relief in 70-86% of patients undergoing the procedure for UUI according to several recent prospective studies. Although the success rates 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.

The microbiome refers to the genetic material of the micro-organisms present in a particular environment. The role of the microbiome has recently been implicated in several disease states (obesity, inflammatory bowel disease, and functional bowel disease. Initially, the urinary microbiome was not a part of the "human microbiome project" as it was widely accepted that urine is sterile. However, recent studies have noted the presence of a urinary microbiota in adult women without clinical urinary tract infections. Furthermore, recent studies have shown that the urinary microbiome differs among women with UUI versus those without UUI and also among women with interstitial cystitis / painful bladder syndrome versus those without it. These studies suggest that the urinary microbiome plays a role in the development and continuation of urinary symptoms.

Because of the invasiveness of the SNM procedure, it would be helpful to have a way to predict treatment success. Investigators in this study propose that the urinary microbiome may change in women before and after SNM implantation and hope to describe these changes by conducting this study. Investigators 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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

UUI patients undergoing SNM

Urine specimens, questionnaire, and medical data will be collected from subjects that have UUI and are undergoing InterStim placement (SNM).

InterStim Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Sacral Neuromodulation

Eligibility Criteria

Inclusion Criteria

• Women over the age of 18 with UUI planning to undergo SNM implantation will be included if they have at least 2 UUI episodes on a baseline 3-day diary.
• Willing and able to complete study visits, questionnaires and diaries
• Women previously treated with OAB medication are permitted to participate, but must be off of all medications for a minimum of 4 weeks prior to the performance of the baseline 3-day bladder diary and baseline assessments. They will be required to stay off any OAB medications for the duration of the study.

Exclusion Criteria

• Neurologic disease (including multiple sclerosis, spinal cord injury, history of cerebrovascular accident, significant peripheral neuropathy)
• Pregnancy
• History of recurrent UTI in last 6 months by definition (3 culture proven UTI in 1 year or 2 culture proven UTI in 6 month period), or women who are receiving treatment for recurrent UTI
• Prolapse beyond the hymen
• Other contraindication to SNM
• Microscopic hematuria, as defined as 3 or more RBC/hpf on complete microscopic urinary analysis, without appropriate work-up (renal imaging and cystoscopy)
• History of pelvic radiation
• History of previous neuromodulation therapy including intravesical botulinum toxin, sacral neuromodulation or peripheral tibial nerve stimulation.

Deferral Criteria:

• Recent systemic antibiotic exposure (within the past 4 weeks)
• Urinary Tract Infection (UTI) at time of enrollment or sample

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

American Urogynecologic Society

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: collaborator

University of North Carolina

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Saint Francis Hospital and Medical Center

UNKNOWN

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00202669

Identifier Type: -

Identifier Source: org_study_id