PTNS for Urinary Incontinence

(BUTTON Trial)

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

36 Participants Needed

Trial Summary

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

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

Is PTNS safe for treating urinary incontinence?

PTNS (Percutaneous Tibial Nerve Stimulation) is considered a safe and well-tolerated treatment for urinary incontinence and other conditions, with no major complications reported in the literature. ^{1 2 3 4 5}

How is PTNS treatment different from other treatments for urinary incontinence?

PTNS (Percutaneous Tibial Nerve Stimulation) is unique because it is a minimally invasive treatment that involves stimulating the tibial nerve near the ankle to help control bladder function, unlike other treatments that may involve medication or surgery. ^{1 4 6 7 8}

What is the purpose of this trial?

This study is designed to evaluate whether bilateral Posterior Tibial Nerve Stimulation is more effective than unilateral Posterior Tibial Nerve Stimulation at treating overactive bladder and urge urinary incontinence

Research Team

Kyle Wohlrab, MD

Principal Investigator

Women and Infants Hospital of Rhode Island

G. Sarah Napoe, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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]

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 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]

References

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

Percutaneous tibial nerve stimulation for treatment of overactive bladder and urinary retention in an elderly population. [2010]

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

Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation. [2023]

3. Germany 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Does percutaneous tibial nerve stimulation improve global pelvic function in women with faecal incontinence? [2017]

5. Hungary pubmed.ncbi.nlm.nih.gov

[Efficacy of the percutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms]. [2019]

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

Percutaneous tibial nerve stimulation as an off-label treatment of clitoral pain. [2014]

7. Switzerland 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. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Percutaneous Tibial Nerve Stimulation Improves Female Sexual Function in Women With Overactive Bladder Syndrome. [2018]