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Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection

NCT07707791 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-07-16

No results posted yet for this study

Summary

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.

Conditions

  • Overactive Bladder (OAB)
  • Botulinum Toxin Injection
  • Procedural Pain Relief
  • Anxiety

Interventions

DEVICE

Active Pretibial TENS

Transcutaneous electrical nerve stimulation delivered through pads placed bilaterally on the pretibial region, with the device turned on (active stimulation) during the intravesical onabotulinumtoxinA injection.

DEVICE

Sham Pretibial TENS

Transcutaneous electrical nerve stimulation pads placed bilaterally on the pretibial region in an identical manner, but with the device not activated (no electrical stimulation delivered), during the intravesical onabotulinumtoxinA injection.

Sponsors & Collaborators

  • Başakşehir Çam & Sakura City Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2027-02-20
Completion
2027-03-10

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07707791 on ClinicalTrials.gov