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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Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905