Sacral Neuromodulation for Urge Incontinence

Overseen By Rowena Shi

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Diabetes, Neurological diseases, Bladder malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

193 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores sacral neuromodulation, a therapy using electrical impulses to regulate bladder function, for individuals with urgency incontinence, which causes sudden, strong urges to urinate. The research aims to determine if shortening the test phase, known as percutaneous nerve evaluation (PNE), from 7 days to 3 days affects the number of participants eligible for permanent treatment. Participants will be randomly assigned to either a 3-day or a 7-day test group to compare outcomes. Women who frequently experience sudden urges to urinate that disrupt daily life might be suitable candidates for this trial. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance treatment options for urgency incontinence.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that sacral neuromodulation is safe for urge incontinence?

Research has shown that sacral neuromodulation (SNM) is generally safe for treating urge incontinence. Studies have found that most people tolerate SNM well. Evidence supports its long-term use for bladder and bowel problems without major safety concerns. Although some side effects have been reported, they are usually mild and manageable. Since its introduction in 1998, this treatment has increased confidence in its safety for patients. Overall, SNM is a safe option for those dealing with urge incontinence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sacral neuromodulation for urge incontinence because it offers a unique approach compared to standard treatments like medications and behavioral therapies. Instead of relying on drugs or lifestyle changes, sacral neuromodulation directly targets the nerves that influence bladder function, potentially offering quicker relief from symptoms. The trial explores two different durations—3-day and 7-day trial periods—for the sacral neuromodulation setup, which could provide insights into optimizing treatment length for better outcomes. This method holds promise for those who haven’t found success with traditional options, as it could offer a more direct and effective solution for managing urge incontinence.

What evidence suggests that this trial's techniques could be effective for urge incontinence?

Research shows that sacral neuromodulation (SNM) effectively treats urge incontinence. Studies have found that it reduces bathroom visits and increases bladder capacity. In one study, 61% of patients experienced significant symptom improvement. Additionally, 99% of patients responded well when the device was initially placed, indicating effective nerve stimulation. The FDA approved SNM in 1998, and evidence supports its long-term effectiveness and safety for bladder issues. Participants in this trial will be randomized into either a 3-day or 7-day trial arm to evaluate the effectiveness of different trial durations for sacral neuromodulation. ^{1 2 3 4 6}

Who Is on the Research Team?

Kimberly Kenton, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals with overactive bladder and urge urinary incontinence who haven't had relief from other treatments. Participants should be candidates for sacral neuromodulation, a device-based therapy. The study excludes those who don't meet the specific medical criteria set by the researchers.

Inclusion Criteria

I am willing and able to follow all study requirements.

Grossly neurologically normal exam

>/=5 UUI episodes on a 3-day bladder diary with urge incontinence representing >/=50% of total incontinence episodes recorded or >/=8 per day for 2 days on a 3-day bladder diary

Exclusion Criteria

I have advanced pelvic organ prolapse or I currently use a pessary.

I have a significant neurological condition like MS, severe nerve damage, or a complete spinal cord injury.

I have stress urinary incontinence or mixed with stress being the main issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Percutaneous Nerve Evaluation (PNE) Trial

Participants undergo a PNE trial phase for sacral neuromodulation, randomized to either a 3-day or 7-day trial

3 or 7 days

2 visits (in-person)

Full SNM Implantation

Participants with adequate therapeutic response during PNE trial progress to full sacral neuromodulation implantation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after full SNM implantation

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Sacral neuromodulation

Trial Overview

The trial tests whether a shorter, 3-day evaluation period using percutaneous nerve evaluation (PNE) before full implantation of a sacral neuromodulation device is as effective as the traditional 7-day test at predicting success with the treatment.

How Is the Trial Designed?

Group I: 3-day trial Experimental Treatment 1 Intervention

Patients randomized to the 3-day trial arm will undergo a 3-day PNE trial phase for sacral neuromodulation. Participants will have the PNE placed in the office and return on day 3 for PNE removal.

Group II: 7-day trial Active Control 1 Intervention

Patients randomized to the73-day trial arm will undergo a 7-day PNE trial time for sacral neuromodulation. Participants will have the PNE placed in the office and return on day 7 for PNE removal.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Atrium Health Wake Forest Baptist

Collaborator

Trials

3

Recruited

250+

Allegheny Health Network

Collaborator

Trials

6

Recruited

1,100+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

University of Texas

Collaborator

Trials

193

Recruited

143,000+

Allegheny Health Network

Collaborator

Trials

7

Recruited

1,700+

Atrium Health Wake Forest Baptist

Collaborator

Published Research Related to This Trial

Electrophysiological monitoring during sacral neuromodulation surgery effectively confirmed the correct placement of the lead at the S3 sacral root in two patients, enhancing the accuracy of the procedure.

This method allowed for the detection of nerve responses with lower stimulation intensity, which may improve patient safety and comfort during the implantation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Importance of the neurophysiological evoked potential register during the implantation of a sacral neuromodulator]. Zeller, FL., Lassalle, G.[2019]

A survey of 31 high-volume providers of sacral neuromodulation revealed that 100% administered preoperative antibiotics, with cefazolin and vancomycin being the most common choices, highlighting a strong emphasis on infection prevention during surgery.

Despite the high rates of antibiotic use, only 13% of providers routinely screened for methicillin-resistant Staphylococcus aureus, indicating a potential gap in infection control practices that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Practice Patterns of Infection Prophylaxis for Sacral Neuromodulation Device: A Survey of High Volume Providers. Lee, EW., Lucioni, A., Lee, UJ., et al.[2023]

Sacral neuromodulation has become a safe and effective treatment for various lower urinary tract disorders, including intractable urge incontinence, urgency-frequency, and nonobstructive urinary retention, as recognized by FDA approval.

This therapy is particularly relevant for elderly patients, addressing the complexities of incontinence treatment in this population, highlighting its growing acceptance and application in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation in the older woman. McAchran, SE., Daneshgari, F.[2009]

In a study of 25 patients over 55 years old with urge incontinence who had not responded to conventional treatments, 48% showed improvement with sacral neuromodulation test stimulation, qualifying for permanent implantation.

After an average follow-up of 7.8 months, all implanted patients experienced over a 50% reduction in incontinent episodes, with 2 patients achieving complete dryness, indicating that sacral neuromodulation can be effective in older populations, though cure rates may be lower than in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation in an older, urge-incontinent population. Amundsen, CL., Webster, GD.[2019]

Sacral neuromodulation is a safe and effective treatment for idiopathic bladder overactivity, with over 75% of patients experiencing a significant reduction in incontinence episodes after the procedure.

The technique involves a temporary stimulation test to assess nerve integrity before permanent implantation, and its success relies on careful patient selection and ongoing adjustments to stimulation parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation as a functional treatment of bladder overactivity. Vignes, JR., de Seze, M., Guerin, J., et al.[2019]

In a study involving six conscious female sheep, acute sacral neuromodulation significantly increased bladder capacity from 75.2 ml to 118.7 ml, demonstrating a nearly 60% improvement.

This large animal model provides a valuable platform for further testing and development of sacral neuromodulation therapies, allowing for exploration of new stimulation parameters and methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Chronic, Conscious Large Animal Platform to Quantify Therapeutic Effects of Sacral Neuromodulation on Bladder Function. Brink, TS., Zimmerman, PL., Mattson, MA., et al.[2019]

Sacral neuromodulation is an FDA-approved therapy that has shown significant long-term efficacy in treating refractory overactive bladder, urinary retention, and fecal incontinence, supported by recent studies like the InSite trial.

Advancements in surgical techniques and device programmability have improved the safety and effectiveness of sacral neuromodulation, while new animal models are paving the way for future research on this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation and female pelvic disorders. Noblett, K.[2018]

Approximately 75% of patients with urge incontinence experience significant improvements after receiving a permanent sacral neuromodulation implant, indicating its efficacy as a treatment option.

However, there is an initial failure rate of about 25%, highlighting the need for better patient selection based on factors like sex differences, urodynamic parameters, and psychological factors to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation in the treatment of the unstable bladder. Bosch, JL.[2019]

In a study of 120 patients with chronic fecal incontinence, sacral nerve stimulation led to a significant reduction in fecal incontinence episodes, from an average of 9.1 per week at baseline to 1.7 at 5 years, with 89% of patients experiencing at least a 50% improvement.

The quality of life for patients improved significantly over the 5-year period, although 35.5% of patients required device revisions or replacements, indicating a need for ongoing improvements in device management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. Hull, T., Giese, C., Wexner, SD., et al.[2022]

A review of over 44,000 adverse event reports related to sacral neuromodulation (SNM) devices found that many reported complications (43.2%) were not true adverse events but rather issues related to device use and the need for better technical support.

The low number of lawsuits (only four identified) over 24 years suggests that SNM devices have a strong safety profile, with complications often stemming from inappropriate patient selection or lack of follow-up rather than device malfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database. Carlton, CE., Souders, CP., Chertack, NA., et al.[2023]

Sacral nerve neuromodulation can be an effective treatment for patients with motor urge incontinence when other conservative therapies do not work, showing durable effects in most cases.

Despite its effectiveness, there is a high failure rate in treatment outcomes, and the exact mechanism of how neuromodulation works remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral nerve neuromodulation in the treatment of refractory motor urge incontinence. Ruud Bosch, JL., Groen, J.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11645166/

A Five-Year Retrospective Study on the Clinical Outcomes ...

revealed that 61% of patients who got SNS experienced a therapeutic success rate for overactive bladders, while 42% of patients who received ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772973724006301

Sacral neuromodulation for urinary incontinence

99% of patients had a motor or sensory response at time of placement highlighting the effectiveness of the lead with regard to nerve stimulation. 107 ...

3.

evidence.nejm.org

evidence.nejm.org/doi/full/10.1056/EVIDoa2200071

Sacral Neuromodulation for Neurogenic Lower Urinary Tract ...

Of 124 patients undergoing SNM testing, 65 (52%) had successfully improved lower urinary tract function. Of these, 60 patients (median age, 49.5 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5087764/

Sacral neuromodulation in overactive bladder: a review and ...

Studies have demonstrated that it is an effective treatment for OAB and urge incontinence as indicated by decreased number of voids, increased bladder capacity ...

5.

cms.gov

cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39543&ver=5

LCD - Sacral Nerve Stimulation for the Treatment of Urinary ...

Data supports the long-term efficacy and safety of SNS for the treatment of bladder and bowel dysfunction. Siegel, et al.7 conducted a multicenter clinical ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8748304/

Long-term Outcomes of Sacral Nerve Stimulation in Pelvic ...

The aim of this study was to analyze the long-term outcomes of sacral nerve stimulation (SNS) in both idiopathic and neurogenic pelvic floor disorders.