Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection

Starting soon · Not applicable · Has a placebo group

Conditions studied: Overactive Bladder (OAB), Botulinum Toxin Injection, Procedural Pain Relief, Anxiety

In brief

Overactive bladder is a common condition that causes a frequent, urgent need to urinate and can significantly reduce quality of life. When other treatments do not work well enough, doctors can inject a medication called onabotulinumtoxinA (a form of botulinum toxin) into the bladder wall. This procedure is often done in the office and is effective, but it can cause pain and anxiety during the injection. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, drug-free method that uses mild electrical pulses delivered through pads placed on the skin. It is thought to reduce the sensation of pain and is already used to help with discomfort during some office procedures. The purpose of this study is to find out whether applying TENS to the front of the lower legs (the pretibial area) reduces pain and anxiety in patients undergoing an intravesical onabotulinumtoxinA injection. Participants will be randomly assigned to one of two groups. In one group, the TENS device will be turned on (active). In the other group, the pads will be placed in the same location but the device will not be turned on (placebo). Neither the patient nor the doctor performing the assessment will know which group the patient is in. Pain will be measured during the procedure using a visual analog scale. Anxiety will be measured before the procedure using a standard questionnaire, and patient satisfaction will be measured afterward. The study aims to enroll 68 participants in total.

Key facts

Study ID

NCT07707791

Run by

Başakşehir Çam & Sakura City Hospital

People needed

68

Starts

2026-07-20

Expected to finish

2027-03-10

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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