Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection

Sponsor
Başakşehir Çam & Sakura City Hospital
Study ID
NCT07707791
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active Pretibial TENS — DEVICE
    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.
  • Sham Pretibial TENS — DEVICE
    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.

Study Details

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 Dates

First listed
Jul 16, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Feb 20, 2027
Completion
Mar 10, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Active TENS
    TENS pads are applied bilaterally to the pretibial region and the device is operated in active mode during the intravesical onabotulinumtoxinA injection. The standard intravesical BTX-A injection is performed according to routine clinical protocol.
  • Placebo Comparator: Placebo TENS (Sham)
    TENS pads are applied to the same pretibial anatomical region but the device is not activated (sham). The standard intravesical BTX-A injection is performed according to routine clinical protocol, identical to the active group.

Primary Outcome Measure

Procedural Pain Score (Visual Analog Scale, VAS) [ Time Frame: During the intravesical onabotulinumtoxinA injection procedure (single assessment at the time of the procedure) ]

Central Contacts

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