Overactive Bladder (OAB)NCT07707791
Pretibial TENS for Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection
A study testing Active Pretibial TENS in people with Overactive Bladder (OAB) and Botulinum Toxin Injection, run by Başakşehir Çam & Sakura City Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder (OAB), Botulinum Toxin Injection, Procedural Pain Relief
- What is being tested?
- Active Pretibial TENS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 10 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Pretibial Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Anxiety During Intravesical OnabotulinumtoxinA Injection: A Double-Blind, Randomized, Placebo-Controlled 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.
Read more
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.
Read the detailed description
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.
- Being tested
- Active Pretibial TENS, Sham Pretibial TENS
- Keywords
- Transcutaneous Electrical Nerve Stimulation, Intravesical Injection, Overactive Bladder, Procedural Pain
- Medical subject headings
- Urinary Bladder, Overactive, Anxiety Disorders, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Pretibial TENSDevice
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 TENSDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Pretibial TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately before the intravesical onabotulinumtoxinA injection procedure (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 into two parallel groups (active TENS vs. inactive/placebo TENS) applied during intravesical onabotulinumtoxinA injection.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SEZGIN, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707791
- Sponsor's protocol ID
- OAB-TENS-BTXA-2026
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will not be shared publicly. De-identified data may be made available upon reasonable request to the corresponding author, subject to institutional and ethics committee approval.
Publications
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.
PubMed 30971304