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Shocking the bladder: TENS vs PTNS for urgency

NCT ID NCT05309993

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This study compared two nerve stimulation treatments—TENS (a skin patch) and PTNS (a needle near the ankle)—for women with overactive bladder who had not gotten relief from lifestyle changes or medication. The goal was to see if TENS works as well as PTNS to improve quality of life. However, the trial was stopped early and only enrolled 27 participants, so the findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous electrical nerve stimulation (TENS) device and percutaneous tibial nerve stimulation (PTNS) device
What this could lead to
If successful, this could show that a non-invasive TENS device works as well as the more invasive PTNS for overactive bladder, offering a simpler option.
What could go wrong
The trial was terminated early with only 27 participants, so results are very limited. It is a small, early-stage study that may not provide clear answers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Jun 2022

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female Subjects ≥18 years of age * OAB, UUI or Mixed Urinary Incontinence with urgency predominant symptoms and more bother from UUI than stress urinary incontinence * 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 * Willing to complete study questionnaires * Willing to adhere to 12 office visits for PTNS over 3 months if randomized to that arm * No contraindication to undergoing PTNS or TENS therapy Exclusion Criteria: * Age \< 18 years * Presence of urinary fistula * Male genital anatomy * Undergoing evaluation or treatment of recurrent (2 or more infections in the last 6 months or 3 or more infections in the last 12 months) or current urinary tract infection * Current Bladder stones * Bladder cancer or suspected bladder cancer * Gross Hematuria * Pregnancy or planning to become pregnant during the study * Cognitive impairment * Central or peripheral neurologic disorders such as multiple sclerosis, Parkinson's disease, spina bifida, spinal cord lesions, etc. * Metal implants such as pacemaker, implantable defibrillator, or metal implants where PTNS or TENS device needs to be placed (ankle/leg) * Uncontrolled diabetes * Diabetes with peripheral nerve involvement * Current use of anticoagulants (excluding aspirin) * Current use of anticholinergics or use within the last 4 weeks * Current use of botox bladder injections or bladder botox injection within the last year (12 months) * Current use of sacral neuromodulation therapy or currently implanted sacral neuromodulation device or leads * Bladder outlet obstruction * Urinary retention or gastric retention * Painful Bladder Syndrome/Interstitial Cystitis * Unable to be contacted for follow up by telephone * Inability to speak/read/understand English or Spanish

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Conditions

The condition(s) this trial relates to.

overactive bladder Urinary Incontinence, Urge

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of New Mexico

    Albuquerque, New Mexico, 87106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.