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Could a gentle leg tingle replace pain pills during bladder botox?

NCT ID NCT07707791

Symptom relief Sponsor: Başakşehir Çam & Sakura City Hospital Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests whether applying mild electrical pulses (TENS) to the shins can reduce pain and anxiety in people receiving Botox injections into the bladder for overactive bladder. Participants are randomly assigned to receive either active TENS or a sham device during the injection. Neither the patient nor the doctor knows which group they are in. The goal is to see if this simple, drug-free approach makes the procedure more comfortable.

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) applied to the pretibial area
What this could lead to
If it works, this could offer a simple, drug-free way to reduce pain and anxiety during a common office procedure for overactive bladder.
What could go wrong
This is a small, early-stage trial with only 68 participants, and the placebo effect may be strong. TENS may not provide meaningful relief for everyone.

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.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Diagnosis of overactive bladder (OAB) with an indication for intravesical onabotulinumtoxinA (BTX-A) treatment * No previous history of TENS application * Age 18 years or older * Provision of written informed consent Exclusion Criteria: * Presence of a cardiac pacemaker or any implanted neuromodulator device * Impaired skin integrity in the pretibial region or peripheral neuropathy * Pregnancy * Coagulopathy that contraindicates the procedure, or active urinary tract infection

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder overactive bladder Pain, Procedural

As listed by the trial registrant

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

Anxiety Botulinum toxin injection Overactive bladder (OAB) Procedural pain relief

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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