Sacral Neuromodulation for Overactive Bladder

(PEER 2 Trial)

Recruiting at 5 trial locations

Overseen By Colin Goudelocke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedtronicNeuro

Must be taking: OAB, NOUR, FI medications

Disqualifiers: Neurostimulator, Pacemaker, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial collects data on how the body functions throughout the treatment period. It aims to understand the effects of therapy by monitoring physiological signals. The specific patient group is not mentioned, suggesting it may include a wide range of participants.

Do I need to stop taking my current medications to join the trial?

No, you don't need to stop taking your current medications. In fact, you must maintain your current medication regimen (dosage and frequency) throughout the therapy evaluation period.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current medications. The trial requires participants to maintain their current medication regimen throughout the study.

What data supports the idea that Sacral Neuromodulation for Overactive Bladder is an effective treatment?

The available research shows that Sacral Neuromodulation (SNM) is a well-established treatment for overactive bladder, especially when other treatments have not worked. It has been used successfully for nearly 40 years to help manage symptoms. One study highlights its effectiveness even after patients have tried other treatments like onabotulinumtoxinA. Additionally, SNM is noted for reducing the need for other interventions, such as catheterization, in patients with urinary retention, which suggests its effectiveness in improving bladder function. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Sacral Neuromodulation for Overactive Bladder?

Sacral neuromodulation (SNM) is a well-established treatment for overactive bladder and has been used successfully for nearly 40 years. It is also effective for other conditions like urinary retention and fecal incontinence, showing its broad effectiveness in treating pelvic disorders. ^{1 2 3 4 5}

What safety data is available for sacral neuromodulation in treating overactive bladder?

Sacral neuromodulation (SNM) has been used for over two decades since its approval in 1997 for treating overactive bladder (OAB) that is resistant to other treatments. Studies indicate that SNM is a safe and effective therapy for managing urinary and fecal incontinence. The InterStim devices, including the rechargeable InterStim Micro, have been evaluated for safety and clinical performance, with ongoing studies confirming their safety in treating OAB. Over 350,000 SNM devices have been implanted since FDA approval, with safety data collected over a decade providing insights for informed consent and patient counseling. Technological and surgical advancements in SNM have also contributed to improved safety and treatment success. ^{6 7 8 9 10}

Is sacral neuromodulation safe for humans?

Sacral neuromodulation (SNM) has been used for over two decades and is generally considered safe for treating conditions like overactive bladder and incontinence. Studies have shown it to be a minimally invasive and reversible therapy with a good safety profile, although detailed long-term safety data is still limited. ^{6 7 8 9 10}

Is Sacral Neuromodulation a promising treatment for Overactive Bladder?

Yes, Sacral Neuromodulation is a promising treatment for Overactive Bladder. It is a minimally invasive procedure that uses a small device to send gentle electrical pulses to nerves in the lower back, helping to control bladder function. Many patients experience significant improvement, with more than three-quarters seeing a reduction in incontinence episodes by over 50%. It has been used successfully for nearly 40 years and is considered safe when performed by experienced professionals. ^{1 2 3 4 11}

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

Sacral neuromodulation is unique because it involves implanting a small device in the upper buttocks that sends mild electrical pulses to the sacral nerves, helping to regulate bladder function. Unlike other treatments, it is minimally invasive and can be used when other therapies, like medications, have not worked. It also includes a temporary test phase to ensure effectiveness before permanent implantation. ^{1 2 3 4 11}

Research Team

Anne Miller

Principal Investigator

Medtronic Pelvic Health

Eligibility Criteria

This trial is for adults with overactive bladder who can complete diaries, attend visits, and follow the study protocol. They must be candidates for or already receiving Medtronic InterStim lead implant therapy. Exclusions include stress incontinence dominance, urinary tract obstruction, enrollment in other studies that could affect results, recent tibial neuromodulation therapy, planned MRIs during the study period, pregnancy or planning to become pregnant, poor compliance likelihoods, certain neurological conditions like multiple sclerosis or spinal cord injury.

Inclusion Criteria

I have been diagnosed with overactive bladder based on a voiding diary.

I am a candidate for or am getting a Medtronic InterStim device.

I have been diagnosed with overactive bladder based on my voiding diary.

Exclusion Criteria

I have a blockage in my urinary tract.

My overactive bladder is due to surgery or injury.

I am aware of my upcoming diathermy treatment for overactive bladder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo therapy evaluation and physiological signals are collected

7 months

Multiple visits at several timepoints

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sacral Neuromodulation

Trial Overview The PEER 2 Study is testing sacral neuromodulation by collecting physiological signals at different times during the therapy evaluation period. It aims to understand how this treatment affects patients with bowel incontinence and overactive bladder symptoms.

Participant Groups

Group I: Pelvic health Electrically Evoked Recording (PEER) 2 Study Experimental Treatment 1 Intervention

Collect physiological signals

Sacral Neuromodulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence

Approved in European Union as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Approved in Canada as InterStim for:

• Overactive bladder
• Urinary urgency
• Frequency
• Urge incontinence
• Nonobstructive urinary retention
• Chronic fecal incontinence
• Chronic constipation

Who Is Running the Clinical Trial?

MedtronicNeuro

Lead Sponsor

Trials

72

Recruited

20,900+

Geoff Martha

MedtronicNeuro

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Eric Peterson

MedtronicNeuro

Chief Medical Officer since 2020

MD from University of Miami

Findings from Research

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]

Sacral neuromodulation (SNM) has been effectively used for nearly 40 years to treat conditions like refractory overactive bladder syndrome and nonobstructive urinary retention, achieving success rates over 70% even after 5 years of therapy.

The mechanism of SNM involves modulating the activity of neurons associated with bladder control, leading to improved coordination and reduced urgency, although it is not suitable for everyone, such as children or pregnant women, and carries risks like infection and technical failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation in under- and overactive detrusor-quo vadis? : Principles and developments]. Girtner, F., Burger, M., Mayr, R.[2022]

In a study of 36 patients with refractory overactive bladder (OAB) who previously received onabotulinumtoxinA (BTXA) treatment, 63.9% experienced successful outcomes with sacral neuromodulation (SNM), indicating that SNM is an effective option even after BTXA failure.

The satisfaction rate at a mean follow-up of 29.1 months was high, with 73.9% of patients using the device and reporting improvement, suggesting that SNM can provide lasting benefits for patients with OAB who have not responded to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation for refractory overactive bladder after prior intravesical onabotulinumtoxinA treatment. Hoag, N., Plagakis, S., Pillay, S., et al.[2018]

Bilateral stage I lead placement for sacral neuromodulation is the most cost-effective strategy for treating refractory overactive bladder, showing greater effectiveness compared to unilateral placement, with incremental cost-effectiveness ratios of $7600 and $3533 respectively.

No treatment was the least expensive option but also the least effective, highlighting that while cost is important, effective treatment options like bilateral stage I lead placement provide better health outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of test phase implantation strategies for InterStim® sacral neuromodulation. Kantartzis, KL., Shepherd, JP.[2013]

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 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]

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 neuromodulation (SNM) with the InterStim II system has evolved into a minimally invasive procedure, significantly improving treatment success rates for chronic urinary and bowel dysfunction, with a response rate of approximately 80%.

Recent advancements, such as the tined lead and smaller neurostimulator, have enhanced patient comfort, reduced technical failures, and improved quality of life, making SNM a viable option for patients who do not respond to conservative treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. Spinelli, M., Sievert, KD.[2008]

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. Germany pubmed.ncbi.nlm.nih.gov

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

2. Germany pubmed.ncbi.nlm.nih.gov

[Sacral neuromodulation in under- and overactive detrusor-quo vadis? : Principles and developments]. [2022]

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

Sacral neuromodulation for refractory overactive bladder after prior intravesical onabotulinumtoxinA treatment. [2018]

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

Cost-effectiveness of test phase implantation strategies for InterStim® sacral neuromodulation. [2013]

5. 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]

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]

9. 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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Latest technologic and surgical developments in using InterStim Therapy for sacral neuromodulation: impact on treatment success and safety. [2008]

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

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