Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection

NCT07707791 | Not Yet Recruiting

• 1 other identifier: OAB-TENS-BTXA-2026
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Transcutaneous Electrical Nerve Stimulation; Intravesical Injection; Overactive Bladder; Procedural Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  During the intravesical onabotulinumtoxinA injection procedure (single assessment at the time of the procedure)

• 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.

  Immediately after the intravesical onabotulinumtoxinA injection procedure (single assessment)

Secondary Outcomes (1)

• Pre-procedure Anxiety Level (State-Trait Anxiety Inventory, STAI)

  Immediately before the intravesical onabotulinumtoxinA injection procedure (single assessment)

Study Arms (2)

Active TENS

EXPERIMENTAL

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.

Device: Active Pretibial TENS

Placebo TENS (Sham)

PLACEBO COMPARATOR

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.

Device: Sham Pretibial TENS

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.

Active TENS

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.

Placebo TENS (Sham)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Related Publications (1)

• Wong QHY, Lui MW, Yung SSF, Ko JKY, Li RHW, Ng EHY. Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial. Trials. 2019 Apr 11;20(1):205. doi: 10.1186/s13063-019-3227-5.

  PMID: 30971304 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive; Anxiety Disorders; Pain, Procedural

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pain; Neurologic Manifestations

Central Study Contacts

Veysel Sezgin

CONTACT

+905513895655; veyselsezgin1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD VEYSEL SEZGİN

Model Details: Participants are randomized 1:1 into two parallel groups (active TENS vs. inactive/placebo TENS) applied during intravesical onabotulinumtoxinA injection.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): March 10, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months and ending 36 months after publication of the main results.
• Access Criteria: De-identified data will be available to qualified researchers who provide a methodologically sound proposal, approved by the principal investigator and the local ethics committee. Requests should be directed to the corresponding author. A data use agreement may be required.