Sacral Neuromodulation for Overactive Bladder

(PEER 2 Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of sacral neuromodulation for individuals with bladder or bowel issues. Sacral neuromodulation uses a small device to send electrical signals to nerves that control the bladder or bowel, aiming to improve their function. The trial seeks to gather data on these signals during treatment to better understand their impact. It suits those with an overactive bladder, non-obstructive urinary retention, or fecal incontinence who plan to receive a Medtronic InterStim device. Participants should be comfortable tracking their symptoms and adhering to study guidelines. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment options for bladder and bowel issues.

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 prior data suggests that Sacral Neuromodulation is safe for overactive bladder?

Research has shown that sacral neuromodulation is generally safe for treating overactive bladder. Studies have found that patients experience significant symptom improvements over two years without serious side effects from the device. This indicates that the device typically does not cause harmful side effects. Another study confirmed that both sacral neuromodulation systems, including InterStim, are effective and safe for treating overactive bladder. Overall, the treatment is well-tolerated and effectively manages symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sacral Neuromodulation is unique because it targets the communication between the nerves and the bladder to help manage overactive bladder symptoms. Unlike standard treatments like medications or bladder training, which often focus on symptom relief, this approach uses mild electrical pulses to directly modulate nerve activity. Researchers are excited about Sacral Neuromodulation because it offers a novel way to address the root cause of bladder dysfunction, potentially providing more effective and long-lasting relief for patients.

What evidence suggests that Sacral Neuromodulation is effective for overactive bladder?

This trial studies sacral neuromodulation for its effectiveness in treating overactive bladder. A previous study found sacral neuromodulation very effective, with 82% of participants experiencing successful results over five years. Another study reported that 89% of participants saw major improvements in their symptoms after one year. Sacral neuromodulation sends electrical signals to the nerves controlling the bladder, helping to reduce symptoms. Overall, these results suggest that this treatment can effectively manage overactive bladder. ^{3 6 7 8 9}

Who Is on the Research Team?

Anne Miller

Principal Investigator

Medtronic Pelvic Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 (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 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 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]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK567751/

Sacral Neuromodulation - StatPearls - NCBI Bookshelf - NIH Sacral neuromodulation demonstrates notable effectiveness in addressing refractory urinary tract dysfunction and has proven efficacy in patients ...

2. 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 ...

3. medtronic.com medtronic.com/en-us/healthcare-professionals/specialties/bladder-bowel-solutions/therapies-procedures/sacral-neuromodulation/clinical-evidence/long-term-efficacy-study.html

Long-Term Efficacy Study - Sacral Neuromodulation ... The InterStim™ systems offer relief from overactive bladder · 82% of subjects with OAB achieved therapeutic success at 5 years. · Highlights · Safety.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7384085/

One‐year outcomes of the ARTISAN‐SNM study with ... The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.22544

Results of a prospective, randomized, multicenter study ... These data support the primary hypothesis that SNM is superior to SMT in the treatment of OAB. For subjects with UI at baseline, 71% of SNM and ...

6. nature.com nature.com/articles/s41598-022-26267-y

Sacral neuromodulation for overactive bladder using the ... Both sacral neuromodulation systems are safe and effective in treating overactive bladder. The InterStim system may be more beneficial for patients with dry ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7217215/

Two‐year safety and efficacy outcomes for the treatment of ... The Axonics System provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device‐related AEs.

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

Long-term Outcomes of Sacral Nerve Stimulation in Pelvic ... In the BPS/IC group, 83.4% of patients showed a GRA between 50% and 75%, with subjective complete resolution of symptoms in 16.6% of patients. There was a ...

9. medtronic.com medtronic.com/en-us/healthcare-professionals/specialties/bladder-bowel-solutions/therapies-procedures/sacral-neuromodulation/clinical-evidence.html

Clinical Evidence - Sacral Neuromodulation Therapies These clinical studies demonstrate that this therapy effectively reduces symptoms of urge incontinence, urgency-frequency, non-obstructive urinary retention, ...