Using TENS for pain relief during Botox injections for overactive bladder
Transcutaneous Electric Nerve Stimulation For Pain Control During Office Intra-detrusor Onabotulinumtoxin A Cystoscopy Injection for Overactive Bladder: A Phase III Randomized Controlled Trial
This study is testing whether using a TENS unit can help reduce pain during Botox injections for women with overactive bladder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04448171 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Transcutaneous Electric Nerve Stimulation (TENS) units in managing pain during office cystoscopic Botox injections for patients with overactive bladder. It aims to compare the pain relief provided by active TENS versus a sham TENS treatment in a double-blind, randomized, placebo-controlled design. The study is crucial as adequate pain control is essential for the success of the procedure, which is often associated with discomfort. Participants will be women aged 18 and older who are scheduled for this specific treatment and can provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 years or older scheduled to receive Botox injections for overactive bladder.
Not a fit: Patients who have previously used TENS therapy within the last year or have certain medical conditions, such as a pacemaker or epilepsy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management during Botox injections, enhancing patient comfort and satisfaction.
How similar studies have performed: Previous studies have shown success in using TENS for pain management in other procedural settings, suggesting potential for effectiveness in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females age 18 years or older * Scheduled to receive intra-detrusor Onabotulinumtoxin-A injection for Overactive Bladder in the outpatient clinic * Reads, speaks, and understands the English language * Able to understand the requirements of the study, including randomization * Willing and able to provide written informed consent Exclusion Criteria: * Previous use of TENS therapy within one year prior to study enrollment * Has a spouse or first degree relative who has previously used TENS therapy within one year prior to study enrollment * Currently has an implanted pacemaker or automatic cardiac defibrillator * History of epilepsy * Currently pregnant or within 12 weeks postpartum * Unwilling to be randomized
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: John A Occhino, MD, MS — Mayo Clinic
- Study coordinator: Karen P Ishitani, MSN
- Email: ishitani.karen@mayo.edu
- Phone: 507-538-5355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.