Sacral Neuromodulation for Overactive Bladder

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a prospective, randomized-controlled multi-site trial comparing cyclic versus continuous sacral neuromodulation (SNM) 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 data supports the effectiveness of the treatment Sacral Neuromodulation for Overactive Bladder?

Research shows that sacral neuromodulation (SNM) is effective for treating overactive bladder and other urinary issues, with studies highlighting its success in reducing symptoms like urgency and incontinence. The ARTISAN-SNM study specifically found positive outcomes for urinary urgency incontinence using the Axonics System, a rechargeable SNM device. ^{1 2 3 4 5}

Is sacral neuromodulation safe for humans?

Sacral neuromodulation (SNM) is generally considered safe for treating conditions like overactive bladder and urinary incontinence. Studies have shown it to be a minimally invasive and reversible therapy with a good safety profile over both short and medium-term periods. ^{1 3 6 7 8}

How is sacral neuromodulation treatment different from other treatments for overactive bladder?

Sacral neuromodulation (SNM) is unique because it involves a minimally invasive procedure where a small device is implanted to send mild electrical pulses to the sacral nerves, helping to regulate bladder function. This treatment is different from medications as it directly targets nerve signals rather than using drugs to manage symptoms. ^{2 3 4 5 8}

Research Team

David Sheyn

Principal Investigator

UH Hospitals Cleveland Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

References

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

One-year outcomes of the ARTISAN-SNM study with the Axonics System for the treatment of urinary urgency incontinence. [2020]

2. France pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation: Rechargeable versus non-rechargeable device. What would the patient preferences be in France? [2022]

3. United States 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. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation for refractory overactive bladder]. [2019]

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

Optimal Lead Positioning in Sacral Neuromodulation: Which Factors Are Related to Treatment Outcome? [2022]

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

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

7. Germany pubmed.ncbi.nlm.nih.gov

Retrospective study of sacral neuromodulator implantations in a French hospital center: Lifespan and hospital costs assessment. [2023]

8. United States 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. [2023]