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

Trial Summary

What is the purpose of this trial?

Sacral neuromodulation (SNM) was approved by the Food and Drug Administration (FDA) for the treatment of urgency incontinence (UUI) in 1998. One of two trial phase techniques are utilized prior to placement of the implantable pulse generator (IPG) to predict a patient's success with the device: a percutaneous nerve evaluation (PNE) or a stage implantation. Patients who experience a \> 50% improvement in UUI symptoms progress to permanent implantation. PNE offers significant advantages compared to a staged implantation including a single anesthetic and operating room trip. Historically, full implantation rates are only 40-50% following PNE versus 70-90% in women who undergo a staged approach. The lower rate of progression to full implantation after PNE may be attributed to lead migration. Newer data suggest up to 90% of PNE trials lead to full implantation. The investigators hypothesize that shortening PNE trial time to 3 days from 7 days will not result in a lower proportion of PNE trials leading to SNM implantation and may offer less time for lead migration. The investigators aim to perform a multi-center, randomized trial to determine if a 3-day PNE trial is not inferior to a 7-day PNE trial with respect to rates of progression to SNM implantation.

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 data supports the effectiveness of the treatment Sacral neuromodulation for Urge Incontinence?

Research shows that sacral neuromodulation can significantly improve symptoms in about 75% of patients with urge incontinence, although there is a 25% initial failure rate. It has been effective in both young and older populations, and ongoing studies are exploring ways to improve patient selection and treatment techniques. ^{1 2 3 4 5}

Is sacral neuromodulation safe for humans?

Sacral neuromodulation has been used in over 350,000 patients since its FDA approval in 1998, and it is considered a safe treatment for various conditions like urge incontinence and fecal incontinence. While there are no standard guidelines for preventing infections related to the device, it is generally regarded as a safe option for managing these conditions. ^{6 7 8 9 10}

How is sacral neuromodulation different from other treatments for urge incontinence?

Sacral neuromodulation is unique because it involves electrical stimulation of the sacral nerves to help control bladder function, unlike other treatments that may rely on medications. This treatment is particularly useful for patients who do not respond to standard drug therapies, and it involves a temporary test phase to ensure effectiveness before a permanent device is implanted. ^{1 2 4 8 11}

Research Team

Kimberly Kenton, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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 a woman over 18, not pregnant, getting SNM for UUI or UF, and have chosen to undergo a PNE test.

I am willing and able to follow all study requirements.

Grossly neurologically normal exam

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation in an older, urge-incontinent population. [2019]

2. Spain pubmed.ncbi.nlm.nih.gov

[Importance of the neurophysiological evoked potential register during the implantation of a sacral neuromodulator]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Sacral nerve neuromodulation in the treatment of refractory motor urge incontinence. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term durability of sacral nerve stimulation therapy for chronic fecal incontinence. [2022]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

National Practice Patterns of Infection Prophylaxis for Sacral Neuromodulation Device: A Survey of High Volume Providers. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Chronic, Conscious Large Animal Platform to Quantify Therapeutic Effects of Sacral Neuromodulation on Bladder Function. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation in the older woman. [2009]

10. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation and female pelvic disorders. [2018]

11. Austria pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation as a functional treatment of bladder overactivity. [2019]