What is the mechanism of action of this treatment?

Percutaneous Tibial Nerve Stimulation (PTNS) and Transcutaneous Electrical Nerve Stimulation (TENS) are treatments that modulate bladder function by stimulating nerves that influence bladder activity. PTNS involves inserting a needle electrode near the tibial nerve in the ankle, which sends electrical impulses to the sacral nerve plexus, thereby regulating bladder contractions. TENS, on the other hand, uses surface electrodes to deliver electrical stimulation through the skin to the same nerve pathways. These treatments are important for OAB patients because they offer a non-surgical, minimally invasive option to reduce symptoms such as urgency, frequency, and incontinence, especially for those who have not responded to first- and second-line treatments.

What side effects are associated with this type of intervention?

Percutaneous Tibial Nerve Stimulation (PTNS) and Transcutaneous Electrical Nerve Stimulation (TENS) are non-surgical treatments used to manage Overactive Bladder (OAB). PTNS involves inserting a needle near the tibial nerve to deliver electrical impulses, while TENS uses surface electrodes to stimulate nerves transcutaneously. Common side effects of PTNS include mild pain or discomfort at the needle insertion site, temporary bruising, and minor bleeding. TENS is generally well-tolerated, but some patients may experience skin irritation or redness at the electrode sites. Both treatments are considered safe with minimal risk of serious adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Overactive Bladder (OAB), including medications such as antimuscarinics (e.g., oxybutynin, tolterodine) and beta-3 adrenergic agonists (e.g., mirabegron). For nerve stimulation therapies, the FDA has approved Percutaneous Tibial Nerve Stimulation (PTNS) as a minimally invasive treatment for OAB. PTNS involves electrical stimulation of the tibial nerve to modulate bladder function. While Transcutaneous Electrical Nerve Stimulation (TENS) is commonly used for pain management, its application for OAB is still under investigation, and specific FDA approval for TENS in OAB treatment is not well-documented.

What other types of research exist?

Promising novel alternatives to PTNS and TENS for overactive bladder patients include: 1) Intravesical botulinum toxin A injections, which have shown efficacy in reducing bladder pain and improving bladder function. 2) Sacral neuromodulation, which involves electrical stimulation of the sacral nerves to improve bladder control. 3) High-frequency spinal cord stimulation, which has been effective in managing bladder symptoms in other conditions and may offer benefits for OAB. These therapies have demonstrated positive outcomes in clinical trials and represent advanced options for OAB management.

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Behavioural Intervention

TENS vs PTNS for Overactive Bladder (INTENSE Trial)

N/A

Recruiting

Led By Kate V Meriwether, MD

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

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

Must have

Failed trial of conservative therapy (including bladder training, fluid modification, diet modification, caffeine restriction, or pelvic floor training)

Failed trial of at least one pharmacologic treatment (anticholinergics, β3- adrenoceptor agonist) either due to inability to take the medication, adverse reaction to medication, or no improvement on medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 12 weeks

Awards & highlights

INTENSE Trial Summary

This trial will compare the quality of life of women with idiopathic overactive bladder before and after treatment with percutaneous tibial nerve stimulation or transcutaneous electrical nerve stimulation of tibial nerve.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects from TENS/PTNS may include discomfort at the site of application, mild pain or skin irritation. Since it's a non-invasive therapy, serious side effects are uncommon but could involve allergic reactions to pads used for TENS.

INTENSE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

INTENSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overactive bladder Questionnaire (OAB-q) Health-Related Quality of Life (HRQOL) score

Secondary outcome measures

Adverse events

Number of urinary incontinence episodes

Number of voids per day

+5 more

INTENSE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Home transcutaneous electrical nerve stimulation (TENS)Experimental Treatment1 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 Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS

2011

Completed Phase 2

~2040

0 / 2Eligibility 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

Percutaneous Tibial Nerve Stimulation (PTNS) and Transcutaneous Electrical Nerve Stimulation (TENS) are treatments that modulate bladder function by stimulating nerves that influence bladder activity. PTNS involves inserting a needle electrode near the tibial nerve in the ankle, which sends electrical impulses to the sacral nerve plexus, thereby regulating bladder contractions. TENS, on the other hand, uses surface electrodes to deliver electrical stimulation through the skin to the same nerve pathways. These treatments are important for OAB patients because they offer a non-surgical, minimally invasive option to reduce symptoms such as urgency, frequency, and incontinence, especially for those who have not responded to first- and second-line treatments.