Status:
TERMINATED
TENS Used for Pain Management During Office Cystoscopy Botox Injections
Lead Sponsor:
Mayo Clinic
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine how Transcutaneous Electric Nerve Stimulation (TENS) units affects pain management during office cystoscopic Botox injections and patient satisfaction with th...
Detailed Description
Overactive bladder (OAB) is a symptom complex pronounced by urinary urgency, affecting up to 12% of the adult population, with a significant negative impact quality on the life. Cystoscopic intra-detr...
Eligibility Criteria
Inclusion
- 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
- Previous use of TENS therapy within one year prior to study enrollment
- Allergy to adhesives
- Currently has an implanted pacemaker or automatic cardiac defibrillator
- History of epilepsy
- Currently pregnant or within 12 weeks postpartum
- Unwilling to be randomized
Key Trial Info
Start Date :
October 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04448171
Start Date
October 28 2020
End Date
December 31 2023
Last Update
August 20 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905