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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active Pretibial TENS
DeviceTranscutaneous 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
DeviceTranscutaneous 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Active TENSExperimental treatment 1 intervention
Group B: Placebo TENS (Sham)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Procedural Pain Score (Visual Analog Scale, VAS)
Pain experienced during the intravesical onabotulinumtoxinA injection, assessed by the physician using a Visual Analog Scale ranging from 0 to 10 cm (0 = no pain, 10 = unbearable pain). Higher scores indicate greater pain. Mean VAS scores will be compared between the active TENS group and the placebo (sham) TENS group.
Time frame
During the intravesical onabotulinumtoxinA injection procedure (single assessment at the time of the procedure)2
Patient Satisfaction (0-10 Likert Scale)
Patient satisfaction with the procedure, assessed after the injection using a 0-10 Likert scale. Higher scores indicate greater satisfaction. Mean satisfaction scores will be compared between the active TENS group and the placebo (sham) TENS group.
Time frame
Immediately after the intravesical onabotulinumtoxinA injection procedure (single assessment)Secondary outcomes
1
Pre-procedure Anxiety Level (State-Trait Anxiety Inventory, STAI)
Anxiety level measured before the procedure using the Spielberger State-Trait Anxiety Inventory (STAI). The relationship between the pre-procedure STAI score and the intraprocedural VAS pain score will be assessed. Higher STAI scores indicate greater anxiety.
Time frame
Immediately before the intravesical onabotulinumtoxinA injection procedure (single assessment)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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