Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBaşakşehir Çam & Sakura City Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Active Pretibial TENS
  • Sham Pretibial TENS

Treatment groups

68 Participants
are divided into 2 treatment groups

Locations

This trial has no locations