Sacral Neuromodulation for Overactive Bladder

Not currently recruiting at 2 trial locations

Overseen By David Sheyn, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: David Sheyn

Disqualifiers: Neurologic diseases, Bladder malignancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 5 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of using sacral neuromodulation (SNM) to help women with overactive bladder (OAB), a condition causing a sudden, strong urge to urinate. The study compares continuous SNM, where the treatment remains on, to cyclic SNM, where the treatment alternates on and off. Women diagnosed with urinary urge incontinence or overactive bladder who have already experienced a 50% improvement from an initial SNM test may be suitable candidates. The goal is to determine which method better controls symptoms and improves quality of life. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for OAB.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that sacral neuromodulation is safe for overactive bladder?

Research has shown that sacral neuromodulation (SNM) is generally a safe treatment for certain bladder issues. Studies have found continuous SNM to be very effective and safe for individuals with urinary retention problems. Long-term evidence suggests it does not increase side effects over time.

Regarding cyclic SNM, research on the Axonics System, a type of SNM device, indicates it significantly improves symptoms of overactive bladder (OAB). Importantly, no serious device-related problems have been reported. Most patients using this system would recommend it to others with similar conditions.

Both continuous and cyclic SNM treatments are well-tolerated, with patients experiencing improvements in symptoms and quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sacral Neuromodulation (SNM) treatments for overactive bladder because they offer innovative stimulation methods. Continuous SNM provides a constant nerve stimulation, which could lead to more consistent symptom relief compared to traditional medications like anticholinergics or beta-3 adrenergic agonists, which work differently and may have side effects. Meanwhile, Cyclic SNM introduces a unique programming mode that alternates between on and off periods, potentially enhancing comfort and reducing habituation over time. Both approaches aim to improve bladder control by directly modulating nerve activity, offering a new avenue for patients who may not respond well to existing therapies.

What evidence suggests that this trial's treatments could be effective for overactive bladder?

Research has shown that sacral neuromodulation (SNM) effectively treats overactive bladder (OAB). One study found that a long-lasting SNM device significantly improved symptoms over two years. Another study reported that 94% of patients noticed positive changes within the first year of treatment.

In this trial, participants will receive either continuous SNM or cyclic SNM. For cyclic SNM, research has shown ongoing improvements in OAB symptoms over two years without serious device-related problems. The Axonics System, a type of SNM, has proven effective in helping people regain bladder control, with many patients recommending it to others with similar issues. Both continuous and cyclic SNM treatments have shown promising results for managing OAB symptoms. ^{2 5 6 7 8}

Who Is on the Research Team?

David Sheyn

Principal Investigator

UH Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking women aged 18 or older with a diagnosis of urinary urge incontinence or overactive bladder. Participants should have seen at least a 50% reduction in episodes after an initial SNM test and be willing to complete all study-related tasks.

Inclusion Criteria

I had a successful nerve stimulation trial showing at least 50% improvement in urinary issues.

I am female.

You can speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Baseline evaluation including history, voiding diary, urinalysis, and symptom assessments

1 week

Treatment

Randomized to cyclic or continuous sacral neuromodulation after permanent SNM implantation

5 years

Visits at 1 month, 6 months, 12 months, 3 years, and 5 years post-op

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Follow-up assessments at 1 month, 6 months, 12 months, 3 years, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Continuous SNM
• Cyclic SNM

Trial Overview The study compares two ways of delivering sacral neuromodulation (SNM) for treating overactive bladder: one group will receive continuous SNM, while the other will get cyclic SNM. It's a multi-site trial where participants are randomly assigned to either method.

How Is the Trial Designed?

Group I: Cyclic SNM Experimental Treatment 1 Intervention

Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to cycling stimulation program mode.

Group II: Continuous SNM Active Control 1 Intervention

Programming of the SNM device will occur as per standard protocol in discussion between patient and SNM representative. The intervention will be to set the device to continuous stimulation programming (SNM is continuously stimulating without "off" periods)

Continuous SNM is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Sacral Neuromodulation for:

• Overactive bladder (OAB)
• Urinary incontinence
• Fecal incontinence
• Chronic constipation

Approved in United States as Sacral Neuromodulation for:

• Overactive bladder (OAB)
• Urinary incontinence
• Fecal incontinence
• Nonobstructive urinary retention

Approved in Canada as Sacral Neuromodulation for:

• Overactive bladder (OAB)
• Urinary incontinence
• Fecal incontinence
• Chronic constipation

Who Is Running the Clinical Trial?

David Sheyn

Lead Sponsor

Trials

5

Recruited

390+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Metro Health, Michigan

Collaborator

Trials

8

Recruited

3,600+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of Louisville

Collaborator

Trials

353

Recruited

76,400+

Published Research Related to This Trial

Sacral neuromodulation (SNM) is a minimally invasive treatment for overactive bladder (OAB) and other pelvic disorders, using a pacemaker to deliver electrical pulses that help regulate nerve signals from pelvic organs.

The article reviews the effectiveness and safety of SNM for patients with refractory OAB, detailing its mechanism of action, implantation techniques, and potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation for refractory overactive bladder]. van Ophoven, A.[2019]

In a study of 66 patients with refractory overactive bladder (OAB), sacral neuromodulation (SNM) demonstrated a medium-term success rate of 75% after an average follow-up of 32 months, significantly reducing the mean number of pads used from 3.5 to 1.2 per day.

The procedure had a complication rate of 14.5%, with a notable 27.3% of patients requiring device explantation within two years, indicating that while SNM is effective, it also carries a risk of complications and a high re-operation rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study. Kaaki, B., Gupta, D.[2020]

The median lifespan of the InterStim™ and InterStim™ II devices used for sacral nerve neuromodulation is 7.29 years and 5.9 years, respectively, indicating that the newer model has a shorter lifespan than the original.

The shorter lifespan of the InterStim™ II is linked to increased long-term hospital costs, suggesting that while both devices are effective for managing incontinence, the choice of device may impact overall treatment expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. Daikh, A., Reymond, F., Lombardo, D., et al.[2023]

In a study of 20 patients with chronic urinary retention (UR), sacral neuromodulation (SNM) therapy showed significant improvement, with 90% of patients successfully receiving an implantable pulse generator after a median of 43 days.

SNM therapy led to a reduction in the median number of daily catheterizations from four to one, indicating its efficacy as a second-line treatment for UR, with only one mild adverse event reported, highlighting its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does sacral neuromodulation lead to relevant reduction in the need for intermittent catheterization? A single-center experience on patients with chronic urinary retention. Denzinger, S., Nowrotek, A., Weingart, P., et al.[2022]

In the ARTISAN-SNM study involving 129 patients with urinary urgency incontinence, the Axonics® System demonstrated a high efficacy rate, with 89% of participants achieving a significant reduction in UUI episodes after one year.

The system is safe, with no serious device-related adverse events reported, and all participants were able to recharge their devices, indicating good user satisfaction with the recharging process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence. Benson, K., McCrery, R., Taylor, C., et al.[2020]

In a study involving 68 subjects with overactive bladder (OAB), the InterStim Micro device demonstrated a significant improvement in health-related quality of life (HRQL) scores at both 3 months (+33 points) and 6 months (+31 points) post-implant, indicating its efficacy in treating OAB.

The safety profile of the InterStim Micro system was confirmed, with a low incidence of adverse events (7.4%), including only one serious adverse event (1.5%), suggesting that this therapy is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6-month results from the global postmarket ELITE study. Goudelocke, C., Xavier, K., Pecha, B., et al.[2023]

In a study of 189 patients undergoing sacral neuromodulation (SNM) for overactive bladder (OAB) and non-obstructive urinary retention (NOR), 59% experienced significant improvement and received permanent implants after a 4-week test period.

The position of the lead and the number of active electrodes did not predict the success of SNM test stimulation, although lateral deflection of the lead was linked to having more active electrodes, suggesting that while lead positioning may not affect immediate outcomes, its long-term impact needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Lead Positioning in Sacral Neuromodulation: Which Factors Are Related to Treatment Outcome? Jairam, R., Marcelissen, T., van Koeveringe, G., et al.[2022]

A survey of 95 patients with overactive bladder, urinary retention, and fecal incontinence revealed that 71% preferred a new rechargeable sacral neuromodulation (SNM) device over the current non-rechargeable option, highlighting its appeal.

Key features influencing patient preference included the smaller size of the new device and its compatibility with full-body MRI, suggesting these factors are important for patient acceptance and treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation: Rechargeable versus non-rechargeable device. What would the patient preferences be in France? Gamé, X., Ruffion, A., Cornu, JN., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772973724006301

Sacral neuromodulation for urinary incontinence Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system. Neurourol ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10841569/

Sacral neuromodulation in the golden years: Treatment ... The indications for SNM were 66% OAB, 16% FI, 16% non-obstructive urinary retention, and 4% pelvic pain. Within the first year, 94% of patients reported ...

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/PMC12185588/

Sacral Neuromodulation for Neurogenic Bladder Dysfunction Recent studies demonstrate that SNM can improve lower urinary tract symptoms, bladder storage, and emptying in select NBD patients.

5. mdpi.com mdpi.com/2077-0383/14/11/3647

Long-Term Outcomes of Sacral Neuromodulation for ... The median follow-up was 35 months (IQR: 28–53). Conclusions: SNM significantly improved pain, urinary symptoms, quality of life, and employment outcomes in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5532891/

Long-term outcome of sacral neuromodulation in patients ... Conclusion: SNM is a highly effective and safe procedure in this subset of the female population with idiopathic refractory nonobstructive urinary retention.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3398598/

Sacral neuromodulation and refractory overactive bladder In all reported studies, clinical success is defined as 50% improvement in one of the relevant urinary voiding parameters. Satisfaction and quality of life ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715922007565

Efficacy and Safety of Sacral Neuromodulation by ... SNM that converts CFS into VFS may be an effective treatment option for patients with DOIC, exhibiting no increase in adverse events.