Pudendal Nerve Stimulation for Stress Urinary Incontinence

Recruiting at 1 trial location

Overseen By Amanda Schonhoff, BSN

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Corewell Health East

Must not be taking: Alpha adrenergics, Tricyclic antidepressants

Disqualifiers: Bladder cancer, Diabetes, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for women with stress urinary incontinence (SUI), a condition that causes urine leaks during activities like coughing or exercising. Researchers are testing whether stimulating certain nerves around the urethra, known as Peri-urethral Stimulation, can help control these leaks. The trial involves using a device to deliver mild stimulation to these nerves and observe the effects on bladder control. Women who have experienced SUI for at least six months and haven't recently used certain medications or treatments might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatment options for SUI.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medication for stress urinary incontinence (SUI) at least 4 weeks before the screening visit.

What prior data suggests that peri-urethral stimulation is safe for stress urinary incontinence?

Research has shown that stimulating the pudendal nerve, similar to stimulating the area around the urethra, is generally safe and feasible. Studies have found that this type of electrical stimulation is usually well-tolerated by individuals with lower urinary tract issues, with most not experiencing serious side effects.

In some studies, electrical stimulation has been successfully applied to the muscles and nerves in the pelvic area connected to the bladder. These studies found it safe and effective for improving bladder control. While mild discomfort or tingling might occur during stimulation, these sensations are typically temporary and manageable.

Overall, evidence suggests that stimulating the area around the urethra is likely safe, based on similar treatments. Participants can be assured that safety remains a top priority in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stress urinary incontinence, like pelvic floor exercises or medications, focus on strengthening muscles or altering bladder function. But peri-urethral stimulation takes a different approach by directly targeting the pudendal nerve, which plays a key role in controlling the muscles involved in urination. This method uses a neurostimulator to deliver precise electrical impulses, potentially offering more immediate control over urinary leakage. Researchers are excited about this technique because it could provide a faster, more targeted treatment option with the potential for fewer side effects compared to systemic medications.

What evidence suggests that peri-urethral stimulation is effective for stress urinary incontinence?

Research has shown that electrical stimulation of the pudendal nerve can help reduce incontinence. Studies have reported about three fewer leakage episodes per day with this method. It sends electrical currents to nerves near the urethra to improve bladder control. Although more research is needed, early reports suggest this technique can help manage stress urinary incontinence. In this trial, participants will undergo urodynamic testing with and without pudendal nerve stimulation to assess its effectiveness. The non-invasive stimulation aims to increase urethral pressure, potentially preventing leaks. ^{1 2 3 5 6}

Who Is on the Research Team?

Kenneth M Peters, MD

Principal Investigator

Corewell Health William Beaumont University Hospital

Are You a Good Fit for This Trial?

This trial is for women over 18 with Stress Urinary Incontinence (SUI) or stress predominant mixed incontinence, lasting at least 6 months. Participants must understand and consent to the study's procedures. Exclusions include recent bacterial UTIs, severe coagulation disorders, pregnancy/breastfeeding, certain medical conditions like Multiple Sclerosis or uncontrolled diseases that affect protocol compliance.

Inclusion Criteria

I understand the study procedures and can give my consent.

Willing and able to undergo the study procedure

I have been diagnosed with stress urinary incontinence for at least 6 months.

Exclusion Criteria

Pregnancy test with positive result during screening or women who are breastfeeding

I do not have any current infections like urethritis, cystitis, or vaginitis.

I have had radiation treatment in my pelvic area.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Stimulation Visit

Participants undergo urodynamic testing with and without peri-urethral neurostimulation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the stimulation visit

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Peri-urethral Stimulation

Trial Overview

The study tests how peri-urethral neurostimulation affects intra-urethral pressure in women with urinary issues. It involves urodynamic testing both with and without stimulation of the pudendal nerve to see if this can help control urination.

How Is the Trial Designed?

Group I: Urodynamic testing and LLP with and without pudendal nerve stimulation Experimental Treatment 1 Intervention

Commercially available stimulation needles or leads will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.

Peri-urethral Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Peri-urethral Stimulation for:

• Urinary Incontinence
• Overactive Bladder Syndrome

Approved in European Union as Peri-urethral Neurostimulation for:

• Urinary Incontinence
• Urge Urinary Incontinence

Who Is Running the Clinical Trial?

Corewell Health East

Lead Sponsor

William Beaumont Hospitals

Lead Sponsor

Trials

153

Recruited

113,000+

Published Research Related to This Trial

Sacral nerve neuromodulation, assessed through Peripheral Nerve Evaluation (PNE), is a promising treatment for chronic voiding dysfunction (CVD), showing good clinical results in 39.2% of patients selected for permanent implantation after initial evaluation.

The PNE procedure was well tolerated with no significant complications, and it effectively identified appropriate candidates for further treatment, demonstrating its safety and utility in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peripheral nerve evaluation:indications, technique and results]. Arlandis Guzmán, S., Alapont Alacreu, JM., Bonillo García, MA., et al.[2019]

Chronic pudendal nerve stimulation (CPNS) using a less invasive technique showed significant improvement in urge incontinence symptoms among 15 neurogenic patients, with the average number of incontinent episodes decreasing from 7 to 2.6 per day.

After 6 months of follow-up, patients who received the implantable pulse generator demonstrated objective improvements in bladder capacity and pressure, indicating the efficacy of CPNS in enhancing pelvic floor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new minimally invasive procedure for pudendal nerve stimulation to treat neurogenic bladder: description of the method and preliminary data. Spinelli, M., Malaguti, S., Giardiello, G., et al.[2006]

The study developed a nerve cuff design that allows for selective stimulation of the pudendal nerve (PN), which could help restore bladder function in individuals with spinal cord injuries.

Using a ten contact nerve cuff and optimizing stimulation techniques significantly improved selectivity for targeting specific fascicles within the PN, potentially enhancing the effectiveness of bladder control interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Model-based analysis and design of nerve cuff electrodes for restoring bladder function by selective stimulation of the pudendal nerve. Kent, AR., Grill, WM.[2021]

A new technique for pudendal nerve stimulation (PNS) involves using a finger introduced per anum to guide the electrode placement, which was confirmed to be accurate through cadaveric dissection.

This method was successfully applied in 20 patients with bowel dysfunction, showing a low complication rate with only one lead displacement over a 12-month follow-up, indicating its safety and reproducibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new minimally invasive technique for pudendal nerve stimulation. George, AT., Dudding, TC., Nicholls, RJ., et al.[2011]

A modified technique of electrical pelvic floor stimulation was successfully tested on six patients with detrusor urinary incontinence, leading to significant muscle contractions and increased urethral closure pressure.

The percutaneous electrode implantation method is described as easy and noninvasive, showing stable effects on pelvic floor function, making it a promising option for chronic electrical stimulation in treating urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique of percutaneous electrode implantation for electrical pelvic floor stimulation. Ishigooka, M., Hashimoto, T., Sasagawa, I., et al.[2019]

In a study of 13 patients with complete cauda equina syndrome, pudendal nerve stimulation (PNS) showed significant improvements in bowel symptoms, with 63% of constipation-predominant patients achieving a 50% or more improvement during a 3-week trial.

All patients with incontinence also experienced a 50% or more reduction in episodes during the trial, indicating that PNS can be an effective treatment for bowel dysfunction in this population, although some patients faced complications after permanent implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pudendal nerve stimulation for bowel dysfunction in complete cauda equina syndrome. George, AT., Dudding, TC., Gurmany, S., et al.[2022]

In a study of 256 female patients with urge incontinence, combining percutaneous tibial nerve neuromodulation with pelvic floor muscle rehabilitation resulted in 93% of patients being dry after three months, demonstrating high efficacy.

The treatment was safe, with no reported adverse side effects, and showed more than double the effectiveness compared to either therapy used alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation of the pudendal, hypogastric, and tibial nerves with pelvic floor muscle rehabilitation in the treatment of urinary urge incontinence. Surwit, EA., Campbell, J., Karaszewski, K.[2022]

In a study involving 40 female rats with stress urinary incontinence (SUI), daily electrical stimulation (ES) of the pudendal nerve significantly improved urethral function compared to stimulation twice a week.

The results suggest that more frequent ES enhances recovery from SUI by promoting better nerve function and neuromuscular junction innervation after nerve injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily bilateral pudendal nerve electrical stimulation improves recovery from stress urinary incontinence. Deng, K., Balog, BM., Lin, DL., et al.[2020]

Citations

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clinicaltrials.gov/ct2/show/NCT05900570

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In this study intra-urethral pressure data will be collected and analyzed with and without peri-urethral neurostimulation.

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The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation ...

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Effectiveness of electrical stimulation for treating male...

Pelvic floor muscle exercise (PFME) is a commonly employed method that improves urethral stability by strengthening the pelvic floor muscles, ...

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Seven studies included measures of clinical efficacy for LUTS and showed a reduction of 2.92 (5.57 to 2.65) in mean daily incontinence episodes (95% CI: 1.52 to ...

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Efficacy and safety of electrical stimulation and pelvic floor ...

This study aimed to assess the efficacy and safety of early pelvic floor rehabilitation bioelectrical stimulation (BES) in postpartum stress urinary ...