Sacral Neuromodulation and the Microbiome

NCT02833402 | Completed

• 1 other identifier: STU00202669
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Urgency Urinary Incontinence

Keywords

Sacral Neuromodulation; Urinary leakage; Urinary incontinence; Urinary microbiome

Outcome Measures

Primary Outcomes (1)

• The abundance of bacteria associated with inflammatory processes in the urinary tract of women with a positive response to SNM (responders) versus those without symptom improvement (non-responders)

  3 months after SNM treatment treatment

Secondary Outcomes (1)

• Changes in the urinary microbial community of responders to SNM therapy

  3 months after initiating SNM treatment

Study Arms (1)

UUI patients undergoing SNM

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

Device: InterStim Therapy

Interventions

InterStim Therapy 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.

Also known as: Sacral Neuromodulation

UUI patients undergoing SNM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over the age of 18 with UUI planning to undergo placement of a sacral nerve modulator will be included if they have at least 2 UUI episodes on a 3-day diary.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• American Urogynecologic Society: collaborator
• University of Pennsylvania: collaborator
• University of Missouri-Columbia: collaborator
• University of North Carolina: collaborator
• University of Washington: collaborator
• Saint Francis Hospital and Medical Center: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will be obtaining urine specimens for microbial analysis.

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret Mueller, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: December 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)