TENS vs PTNS for Overactive Bladder

(INTENSE Trial)

Overseen By Angela Dao, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of New Mexico

Must not be taking: Anticoagulants, Anticholinergics, Botox, others

Disqualifiers: Urinary infections, Bladder cancer, Neurologic disorders, Diabetes, others

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

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments, PTNS (Percutaneous Tibial Nerve Stimulation) and TENS, to determine their effectiveness in improving the quality of life for women with overactive bladder (OAB). Both treatments use gentle electrical stimulation near the ankle to help manage bladder issues. Participants include women who have tried other treatments, such as bladder training or medication, without success and seek non-surgical options. Ideal candidates are more troubled by sudden urges to urinate than by stress-related leaks. As an unphased trial, this study provides participants the opportunity to explore innovative, non-surgical treatments for OAB.

Will I have to stop taking my current medications?

The trial requires that you stop using anticholinergics at least 4 weeks before participating. If you are currently using anticoagulants (except aspirin), you cannot participate in the trial.

What prior data suggests that these treatments are safe for overactive bladder?

Research has shown that percutaneous tibial nerve stimulation (PTNS) safely treats overactive bladder (OAB). Most individuals who responded well to PTNS continued to experience positive results without serious side effects. Studies also indicate that PTNS improves OAB symptoms and is generally well-tolerated.

Similarly, using transcutaneous electrical nerve stimulation (TENS) at home has proven safe for treating OAB. Research highlights that TENS can effectively reduce symptoms without major side effects. Both PTNS and TENS offer non-drug, non-surgical options for managing OAB, providing good alternatives for those seeking different treatment methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for overactive bladder because they offer innovative, non-drug approaches that may have fewer side effects than traditional medications like anticholinergics or beta-3 adrenergic agonists. Posterior Tibial Nerve Stimulation (PTNS) is unique because it involves stimulating a nerve near the ankle, which is thought to help control bladder function, offering a targeted therapy without systemic drug exposure. Home transcutaneous electrical nerve stimulation (TENS) stands out for its convenience, as it allows women to self-administer treatment at home using a simple device, making it potentially more accessible and comfortable than frequent clinic visits. Both treatments aim to offer effective, less invasive options for managing overactive bladder symptoms.

What evidence suggests that this trial's treatments could be effective for overactive bladder?

Research shows that stimulating certain nerves can help with overactive bladder (OAB) symptoms. In this trial, participants will receive either percutaneous tibial nerve stimulation (PTNS) or transcutaneous electrical nerve stimulation (TENS) through random assignment. PTNS has improved symptoms in about 60% of patients, and one study found that 77% of patients maintained improvement even three years after treatment. TENS also shows promise, as studies have found it can significantly reduce OAB symptoms. This non-invasive treatment is effective for both children and adults. Both PTNS and TENS can manage OAB symptoms, especially when other treatments have failed. ^{2 3 4 6 7}

Who Is on the Research Team?

Kate V Meriwether, MD

Principal Investigator

University of New Mexico

Are You a Good Fit for This Trial?

This trial is for women over 18 with overactive bladder (OAB) who've tried and not benefited from standard treatments like medication or pelvic floor training. They should be willing to attend multiple treatment sessions and complete questionnaires, but can't join if they're pregnant, have certain medical conditions like uncontrolled diabetes or neurological disorders, use specific medications, or have metal implants in the area where TENS/PTNS would be applied.

Inclusion Criteria

I have tried and not improved with basic treatments like diet changes or bladder exercises.

I have been diagnosed with overactive bladder or urge incontinence that bothers me more than stress incontinence.

I tried a medication for my condition but stopped because it didn't work, I had side effects, or I couldn't take it.

Exclusion Criteria

I have visible blood in my urine.

I currently have bladder stones.

I am currently being treated or evaluated for a urinary tract infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either PTNS or TENS treatment for overactive bladder

12 weeks

12 visits (in-person for PTNS), daily self-treatment at home for TENS

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PTNS
• TENS

Trial Overview

The study compares two non-surgical treatments for OAB: transcutaneous electrical nerve stimulation (TENS) and percutaneous tibial nerve stimulation (PTNS). Women participating will receive one of these therapies after failing traditional treatments to see which better improves their quality of life.

How Is the Trial Designed?

Group I: Home transcutaneous electrical nerve stimulation (TENS) Experimental Treatment 1 Intervention

Women randomized to the TENS group will be asked to purchase a TENS 7000 device (estimated cost $30) and will administer self-treatment at home, daily for 20 minutes, for 12 weeks total. TENS treatment will be performed as follows (adapted from the most common setting from a s systematic review of TENS for OAB): \- Surface electrodes, 2 x 2 in diameter, will be placed 5 cm cephalad to the medial malleolus of the right or left ankle (patient's choice). The second surface electrode is placed on the medial aspect of the ipsilateral calcaneus. The electrodes are connected to the TENS device with pre-set settings. Women will complete 20-minute daily TENS treatment for 12 weeks total.

Group II: Posterior Tibial Nerve Stimulation (PTNS) Active Control 1 Intervention

Women randomized to the PTNS will be scheduled for sessions once weekly for 30 minutes, for 12 weeks total. The patient sits reclined with their legs elevated on a foot rest. After alcohol swab, a 34 gauge needle is inserted percutaneously 5 cm cephalad to the medial malleolus of the right or left ankle (patient's choice) at a 60 degree angle. A surface electrode is placed on the medial ipsilateral heel. The needle and electrode are connected to a low voltage (9V) electrical stimulator. Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 μsec is increased until flexion of the big toe or fanning of all toes visualized, or until the woman reports a tingling sensation across the heel or sole of the foot. The current is then set to the highest level of tolerable to the patient (0-10 mA) and then she undergoes therapy for 30 minutes.

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?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Published Research Related to This Trial

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 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]

The study aims to evaluate the efficacy of transcutaneous tibial nerve stimulation (TTNS) for treating idiopathic overactive bladder syndrome in children aged 5 to 12 years, comparing it to a sham therapy over 12 weeks.

This is the first randomized controlled trial to assess TTNS in a pediatric population, with the hypothesis that TTNS will be as effective as percutaneous tibial nerve stimulation (PTNS), providing important insights into non-invasive treatment options for overactive bladder in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of transcutaneous tibial nerve stimulation (TTNS) versus sham therapy (part I) and TTNS versus percutaneous tibial nerve stimulation (PTNS) (part II) on the short term in children with the idiopathic overactive bladder syndrome: protocol for part I of the twofold double-blinded randomized controlled TaPaS trial. Ghijselings, L., Renson, C., Van de Walle, J., et al.[2021]

Sacral nerve modulation (SNM) and percutaneous tibial nerve stimulation (PTNS) are both effective treatments for overactive bladder (OAB) symptoms, with therapeutic success rates of 61% to 90% for SNM and 54% to 79% for PTNS based on a review of randomized trials involving at least 20 adult patients.

Both treatments are considered safe, with no life-threatening adverse effects reported, and PTNS is noted for being less invasive and providing quicker results with fewer side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is New in Neuromodulation for Overactive Bladder? Tutolo, M., Ammirati, E., Van der Aa, F.[2019]

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]

Both percutaneous tibial nerve stimulation (PTNS) and transcutaneous tibial nerve stimulation (TTNS) combined with bladder training significantly improved symptoms of idiopathic overactive bladder (OAB) compared to bladder training alone, based on a study of 60 women.

TTNS was found to be more patient-friendly than PTNS, with shorter preparation times, lower discomfort levels, and higher treatment satisfaction, while both methods showed similar overall clinical efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial. Sonmez, R., Yildiz, N., Alkan, H.[2022]

Stimulation of the saphenous nerve (SAFN) at a frequency of 20 Hz significantly reduced bladder contraction rates by about 53.8% and increased bladder capacity by approximately 145.8% in a study involving 26 anesthetized rats.

These results suggest that SAFN stimulation may evoke a bladder-inhibitory reflex, indicating a potential new pathway for treating overactive bladder, although further research is needed to explore its clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency-dependent inhibition of bladder function by saphenous nerve stimulation in anesthetized rats. Moazzam, Z., Yoo, PB.[2019]

In a study of 50 participants who underwent percutaneous tibial nerve stimulation for overactive bladder, 77% maintained significant symptom improvement after 3 years, with a median of 1.1 treatments per month following an initial 12-week treatment period.

Patients experienced substantial reductions in daily voids, nighttime voids, and urge incontinence episodes, with all quality of life measures showing marked improvement, while only one patient reported mild adverse effects, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous tibial nerve stimulation for the long-term treatment of overactive bladder: 3-year results of the STEP study. Peters, KM., Carrico, DJ., Wooldridge, LS., et al.[2022]

In a study of 137 women with overactive bladder, tibial nerve TENS applied to one leg once a week significantly reduced urgency and incontinence episodes compared to a placebo.

Two-leg TENS stimulation, whether once or twice a week, effectively improved nocturia, indicating that the frequency and site of application can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment. Pierre, ML., Friso, B., Casarotto, RA., et al.[2022]

In a study of 402 patients undergoing percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB), 57% continued with maintenance therapy after the initial treatment, indicating PTNS is a viable long-term option for managing OAB symptoms.

However, over 40% of patients who were on maintenance PTNS therapy discontinued treatment due to nonmedical reasons such as logistical challenges and physical strain, highlighting the need for improved support to enhance adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term real-life adherence of percutaneous tibial nerve stimulation in over 400 patients. Te Dorsthorst, MJ., Heesakkers, JPFA., van Balken, MR.[2021]

Citations

1.

frontiersin.org

frontiersin.org/journals/urology/articles/10.3389/fruro.2024.1352701/full

Efficacy and sex-specific outcomes after six episodes of ...

Results: PTNS treatment significantly improved the OAB symptoms and quality of life in men and women. PTNS increased the voided volume (p < 0.05) ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5565382/

Effectiveness of percutaneous tibial nerve stimulation in the ...

PTNS can indeed modulate the voiding and storage function of the bladder leading to an overall subjective improvement of symptoms in about 60% of the patients.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772973724002741

Long term safety, continuation rates and subjective ...

PTNS remains a safe treatment option for patients with refractory OAB with evidence of both subjective and objective improvement to most symptoms.

4.

eurjmedres.biomedcentral.com

eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02262-z

Efficacy and safety of non-invasive low-frequency tibial nerve ...

The TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation. Trial registration number: NCT04999657.

5.

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 ...

6.

laborie.com

laborie.com/product/urgent-pc/

URGENT® PC for Overactive Bladder - US

The Urgent PC helps to treat patients with overactive bladder via non-surgical PTNS. This non-drug method helps treat urinary urgency and frequency.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10219410/

The Investigation of Percutaneous Tibial Nerve Stimulation ...

Current publications demonstrate PTNS to be effective in treating non-obstructive urinary retention, neurogenic bladder, chronic pelvic pain, ...