PTNS for Urinary Incontinence

(BUTTON Trial)

No longer recruiting at 1 trial location

Overseen By G. Sarah Napoe, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Gnankang Sarah Napoe

Disqualifiers: Pregnancy, Pacemaker, Neurogenic bladder, 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: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Posterior Tibial Nerve Stimulation (PTNS) for treating overactive bladder and urge urinary incontinence. It compares unilateral stimulation (one ankle) with bilateral stimulation (both ankles) to determine if stimulating both ankles provides better relief. Women who have tried other therapies without success and are currently on medication might be suitable candidates. As an unphased trial, this study offers the chance to explore innovative treatment options that could improve relief for overactive bladder symptoms.

Do I need to stop my current medications for the trial?

No, you can continue your current medications while participating in the trial.

What prior data suggests that PTNS is safe for treating urinary incontinence?

Research has shown that Posterior Tibial Nerve Stimulation (PTNS) is generally safe and well-tolerated for treating overactive bladder and urinary incontinence. Many patients experience significant symptom relief and report high satisfaction with PTNS. Long-term use of unilateral PTNS on one ankle remains safe, with most patients continuing to see improvements over time. Bilateral PTNS on both ankles is also safe and effective.

Studies have not reported any major safety concerns, and side effects are rare. This suggests that PTNS, whether unilateral or bilateral, is a safe option for those with bladder issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PTNS for urinary incontinence because it offers a non-invasive and potentially more convenient treatment option compared to standard approaches like medications or surgeries. Unlike oral medications that can have systemic side effects, PTNS involves a small needle inserted near the ankle to stimulate nerves that help control bladder function. This method may provide symptom relief without the need for more invasive procedures. The trial is exploring both unilateral and bilateral PTNS, with the latter potentially offering more comprehensive nerve stimulation by targeting both ankles.

What evidence suggests that this trial's treatments could be effective for urinary incontinence?

Research has shown that Posterior Tibial Nerve Stimulation (PTNS) can significantly alleviate symptoms of an overactive bladder (OAB) and sudden urges to urinate. In this trial, participants will receive either Unilateral PTNS or Bilateral PTNS. Those receiving PTNS on one side of the body experience significant improvements in urination frequency, urgency, and accidents. Studies have found that 68% of individuals experienced at least a 50% reduction in sudden urges to urinate when PTNS was applied bilaterally. Another study showed that 77% of patients continued to experience moderate or significant improvement in OAB symptoms over three years with PTNS. Both unilateral and bilateral PTNS are effective, but research suggests that bilateral PTNS might provide even better relief. ^{1 2 3 6 7}

Who Is on the Research Team?

Kyle Wohlrab, MD

Principal Investigator

Women and Infants Hospital of Rhode Island

G. Sarah Napoe, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for women over 18 with overactive bladder or urge urinary incontinence who didn't get better with behavior therapy. They can still be on medication. It's not for pregnant women, those with pacemakers/defibrillators, neurogenic bladder, recent Botox/sacral nerve implants, bleeding disorders, or unhealed ulcers/leg edema near the ankle.

Inclusion Criteria

Patients who consent to participate in the study

I am currently on medication and can continue taking it.

Exclusion Criteria

Pregnant patients

I have a condition where my bladder doesn't function properly due to nerve damage.

I have received Botox or have a sacral nerve stimulation implant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either unilateral or bilateral PTNS treatment for overactive bladder

12 weeks

Weekly visits for PTNS treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PTNS

Trial Overview The study tests if stimulating both sides of the ankle nerves (bilateral PTNS) is more effective than just one side (unilateral PTNS) for treating symptoms like frequent urination and loss of bladder control.

How Is the Trial Designed?

Group I: Bilateral PTNS Experimental Treatment 1 Intervention

34 gauge needle inserted 3cm above the medial ankle on both ankles, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period

Group II: Unilateral PTNS Active Control 1 Intervention

34 gauge needle inserted 3cm above the medial ankle on the ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period

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

Approved in United States as Percutaneous Tibial Nerve Stimulation for:

• Overactive bladder
• Urinary urgency
• Urinary frequency
• Urgency incontinence

Approved in European Union as Percutaneous Tibial Nerve Stimulation for:

• Overactive bladder
• Urinary urgency
• Urinary frequency
• Urgency incontinence

Approved in Canada as Percutaneous Tibial Nerve Stimulation for:

• Overactive bladder
• Urinary urgency
• Urinary frequency
• Urgency incontinence

Who Is Running the Clinical Trial?

Gnankang Sarah Napoe

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study of 41 women undergoing percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB), 51% were found to have female sexual dysfunction (FSD) at the start, and PTNS significantly improved sexual function in these women after 3 months, with 43% showing objective improvement.

The improvements in sexual function were observed even in women who did not have FSD at baseline, indicating that PTNS may enhance sexual health independently of urinary symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Tibial Nerve Stimulation Improves Female Sexual Function in Women With Overactive Bladder Syndrome. Musco, S., Serati, M., Lombardi, G., et al.[2018]

Transcutaneous tibial nerve stimulation (TTNS) is as effective as percutaneous tibial nerve stimulation (PTNS) in treating overactive bladder, based on a systematic review of 4 trials involving 142 patients.

TTNS showed a total complication rate of only 2.1% with no adverse events reported, indicating a potentially safer option compared to PTNS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation. Yang, DY., Zhao, LN., Qiu, MX.[2023]

Percutaneous tibial nerve stimulation (PTNS) is a safe and well-tolerated treatment for overactive bladder syndrome (OAB), showing efficacy comparable to sacral nerve stimulation, making it a viable option for patients who do not respond to or tolerate anti-muscarinic therapy.

PTNS has also been used to treat fecal incontinence and chronic pelvic pain, although many studies on these applications lack quality; importantly, no major complications have been reported following PTNS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of the percutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms]. Kozma, B., Majoros, A., Pytel, Á., et al.[2019]

Percutaneous tibial nerve stimulation (PTNS) is an effective treatment for patients experiencing urinary urgency, frequency, urge incontinence, or urinary retention, especially when other treatments like behavior modification and medications have failed.

PTNS significantly reduces symptoms of overactive bladder and urinary retention, providing a valuable option for patients struggling with these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous tibial nerve stimulation for treatment of overactive bladder and urinary retention in an elderly population. Zinkgraf, K., Quinn, AO., Ketterhagen, D., et al.[2010]

Transcutaneous electrical nerve stimulation (TTNS) is more comfortable for patients compared to percutaneous electrical nerve stimulation (PTNS) while both methods show similar effectiveness in treating overactive bladder (OAB) with urinary incontinence (UI).

Combining TTNS or PTNS with other treatments, such as medications or exercises, leads to greater improvements in reducing urinary incontinence and enhancing quality of life, based on a systematic review of 259 studies, with 19 meeting the inclusion criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous versus Transcutaneous Electrical Stimulation of the Posterior Tibial Nerve in Idiopathic Overactive Bladder Syndrome with Urinary Incontinence in Adults: A Systematic Review. Agost-González, A., Escobio-Prieto, I., Pareja-Leal, AM., et al.[2021]

In a study of 73 patients with fecal incontinence, 18 sessions of posterior tibial nerve stimulation (PTNS) over 6 months significantly improved incontinence severity, as measured by the St. Marks score, from an average of 15.1 to 4.0 (p < 0.001).

PTNS also led to significant increases in anal sphincter pressures, with maximum resting pressure increasing by 9.8 mmHg and maximum squeeze pressure by 25.3 mmHg, indicating enhanced anal sphincter function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous electrical stimulation of the posterior tibial nerve for the treatment of fecal incontinence: manometric results after 6 months of treatment. Manso, B., Alias, D., Franco, R., et al.[2021]

In a case study involving two women with urgency urinary incontinence and clitoral pain, percutaneous tibial nerve stimulation (PTNS) led to significant improvement in urinary symptoms and complete resolution of clitoral pain by the 12th treatment session.

These results suggest that PTNS could be a potential therapeutic option for treating idiopathic clitoral pain, although it is not yet FDA-approved for chronic pain syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous tibial nerve stimulation as an off-label treatment of clitoral pain. Elkattah, R., Trotter-Ross, W., Huffaker, RK.[2014]

In a study of 60 patients with faecal incontinence who underwent percutaneous tibial nerve stimulation (PTNS), significant improvements were observed in bowel continence and quality of life, indicating PTNS is an effective treatment for bowel-related issues.

While PTNS improved bowel function for about two-thirds of patients, the benefits were primarily related to bowel symptoms rather than overall pelvic floor function, suggesting a targeted effect of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does percutaneous tibial nerve stimulation improve global pelvic function in women with faecal incontinence? Kelly, SL., Radley, SC., Brown, SR.[2017]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23219541/

Percutaneous tibial nerve stimulation for the long-term ... A Bayesian model estimated that 77% (95% CI 64-90) of patients maintained moderate or marked improvement in overactive bladder symptoms at 3 years. Compared to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772973724002595

Tibial neuromodulation for lower urinary tract dysfunction ... Although both treatments showed a reduction in OAB symptoms, PTNS showed a greater effectiveness in frequency, nocturia, incontinence episodes and QoL. Later, ...

3. anthem.com anthem.com/medpolicies/abc/active/gl_pw_e003566.html

CG-SURG-126 Tibial Nerve Stimulation The primary efficacy analysis showed 68% (95% CI: 60%-76%) of participants experienced at least a 50% reduction in urgency urinary incontinence ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03535857

Effectiveness of Bilateral PTNS Compared to Unilateral ... The investigators expected more improvement in symptoms from participants receiving bilateral stimulation compared to those with unilateral stimulation. 12 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10648249/

Percutaneous Tibial Nerve Stimulation in the Treatment of ... There have been reports of clinically relevant effects, such as improving voiding frequency, nocturia, urgency, and incontinence episodes, as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11783776/

Home and outpatient electrostimulation in the treatment of ... Home-based ES is shown to be as effective as outpatient ES in the treatment of UI in women. However, data analysis revealed low-quality evidence.

7. mdpi.com mdpi.com/2077-0383/12/21/6783

Percutaneous Tibial Nerve Stimulation in the Treatment of ... Substantial reductions in OAB symptoms, daily micturition frequency, urgency, and urgency incontinence were found in patients with refractory OAB after PTNS.