Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection

Background: Overactive bladder (OAB) is a chronic urological condition that substantially impairs quality of life, and intravesical onabotulinumtoxinA (BTX-A) injection is an effective treatment option. Although performing this procedure in an office setting reduces hospital and operating room costs, the pain and anxiety experienced during the procedure can negatively affect patient comfort. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive, non-pharmacological, and safe analgesic method believed to reduce pain perception through the gate control mechanism. Prior work has reported clinically meaningful reductions in pain scores when active TENS is applied during intravesical BTX-A injection; however, the effect of TENS applied specifically to the pretibial region during this procedure has not been previously investigated.

Objectives: The primary objective is to evaluate the effect of pretibial TENS on pain during office-based intravesical BTX-A injection, assessed using a Visual Analog Scale (VAS). Secondary objectives are to examine the relationship between pre-procedure anxiety level (measured with the Spielberger State-Trait Anxiety Inventory, STAI) and the pain experience, and to measure patient satisfaction using a 0-10 Likert scale.

Design: This is a randomized, double-blind, placebo-controlled trial. Participants will be randomized 1:1 using a sealed-envelope method. Envelopes will be prepared by an independent researcher not involved in conducting the study. Patients will be blinded to whether the device is active or inactive during the procedure, and blinding of the outcome assessment will be maintained.

Groups:

• Active group: TENS pads applied bilaterally to the pretibial region with the device operating in active mode.
• Control group: TENS pads applied to the same anatomical region with the device not activated (placebo).

In both groups, the intravesical BTX-A injection will be performed according to the standard routine clinical protocol without any modification.

Measurements will be collected in the following order as part of the patient's routine clinical visit:

• Before the procedure: the patient completes the Spielberger State-Trait Anxiety Inventory (STAI).
• During the procedure: pain is assessed by the performing physician using a VAS (0-10; 0 = no pain, 10 = unbearable pain).
• After the procedure: patient satisfaction is assessed using a 0-10 Likert scale.

Sample size: Based on a power analysis assuming an effect size (Cohen's d) of 0.7, a significance level (alpha) of 0.05, and power (1-beta) of 0.80, 34 participants per group were required, for a total sample size of 68 participants.

Statistical analysis: Continuous variables will be compared using the Student t-test or the Mann-Whitney U test, as appropriate. Categorical variables will be analyzed using the chi-square test. The relationship between STAI and VAS scores will be assessed using Spearman correlation. A p-value < 0.05 will be considered statistically significant.