What side effects are associated with this type of intervention?

Common treatments for Overactive Bladder (OAB) include antimuscarinic agents and beta-3 adrenergic agonists. Antimuscarinic agents, such as oxybutynin and tolterodine, can cause dry mouth, constipation, blurred vision, and cognitive impairment. Beta-3 adrenergic agonists, like mirabegron, may lead to increased blood pressure, urinary tract infections, and headaches. Both classes of medications aim to reduce bladder muscle overactivity but come with these potential side effects.

What prior FDA approvals exist?

FDA-approved treatments for Overactive Bladder (OAB) include anticholinergic medications such as tolterodine, which help reduce bladder muscle spasms. These medications can cause side effects like dry mouth, blurred vision, and urinary retention. Another class of drugs used for OAB includes beta-3 adrenergic agonists like mirabegron, which relax the bladder muscle to increase storage capacity. These treatments aim to alleviate symptoms such as frequent urination and urgency. While the context does not directly link these treatments to the Physiological Signal Monitoring study, these medications are relevant to the management of OAB.

What other types of research exist?

Promising, novel alternatives for overactive bladder patients in 2024 include minimally invasive surgical options like Urolift and advanced wearable sensors for continuous monitoring of autonomic activity and circadian rhythms. These technologies offer new ways to manage and treat OAB effectively.

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Neuromodulation Device

Sacral Neuromodulation for Overactive Bladder (PEER 2 Trial)

N/A

Recruiting

Research Sponsored by MedtronicNeuro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for or undergoing Medtronic InterStim lead implant for labeled indication requiring an advanced evaluation

For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary

Must not have

Overactive Bladder Criteria: Current urinary tract mechanical obstruction

Overactive Bladder Criteria: Pelvic floor muscle dysfunction due to surgical intervention or injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day to 7 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here for sacral neuromodulation used in treating overactive bladder and bowel incontinence issues; generally such interventions may cause discomfort at the implant site, changes in bowel or bladder function and potential nerve-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blockage in my urinary tract.

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My overactive bladder is due to surgery or injury.

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

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My main bladder issue is stress incontinence, more than urge incontinence.

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I am pregnant or planning to become pregnant and have an overactive bladder.

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I have a neurological condition like MS, significant nerve damage, or spinal cord injury.

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I have symptoms of a urinary tract infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day to 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day to 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day to 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects with physiological signals collected at each timepoint

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pelvic health Electrically Evoked Recording (PEER) 2 StudyExperimental Treatment1 Intervention

Collect physiological signals

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacral Neuromodulation

2018

N/A

~90

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Overactive Bladder (OAB) include antimuscarinics, beta-3 adrenergic agonists, and neuromodulation therapies. Antimuscarinics work by blocking muscarinic receptors in the bladder, reducing involuntary contractions and increasing bladder capacity. Beta-3 adrenergic agonists relax the bladder muscle by stimulating beta-3 adrenergic receptors, which also helps to increase bladder capacity and reduce urgency. Neuromodulation therapies, such as percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation, modulate nerve signals to the bladder, improving bladder control and reducing symptoms. These treatments are crucial for OAB patients as they target the underlying mechanisms of bladder overactivity, providing symptom relief and improving quality of life.