TENS Used for Pain Management During Office Cystoscopy Botox Injections

  • STATUS
    Recruiting
  • days left to enroll
    36
  • participants needed
    60
  • sponsor
    Mayo Clinic
Updated on 24 November 2021
botox
transcutaneous electrical nerve stimulation
TENS

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 the procedure .

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-detrusor onabotulinumtoxin A is used for the treatment of OAB in participants who do not tolerate or adequately respond to oral anticholinergic medications. The response to the onabotulinumtoxin A injection is transient and requires repeat injections roughly every 6-7 months. Adequate pain control during this procedure is essential for success in the office setting.

Options for adequate pain control during office-based cystoscopy procedures are limited. Currently, varying pain control strategies are being used including local anesthesia (intra-urethral lidocaine, intra-vesicular lidocaine solution), distraction techniques (conversation/music/'squeeze balls'), aromatherapy, intramuscular analgesia, sedation and a combination of these techniques. Despite this, participants often experience pain during the procedure. Trans-cutaneous Electrical Nerve Stimulation (TENS) is a non-pharmacologic, non-invasive and safe method of pain control that involves delivery of electrical impulses to the skin, resulting in a reduction in perceived pain. TENS units have been successfully used for procedural pain management during office hysteroscopy and office colonoscopy. TENS may also help reduce pain during office cystoscopy.

The study is a two arm phase III double-blind, randomized, placebo-controlled trial looking at the effect of TENS unit on pain in participants receiving office based cystoscopic onabotulinum toxin A injection for overactive bladder at the Mayo Clinic in Rochester, Minnesota.

Details
Condition Bladder Disorders, bladder disorder, Overactive Bladder
Treatment Sham TENS, active TENS
Clinical Study IdentifierNCT04448171
SponsorMayo Clinic
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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