TENS Used for Pain Management During Office Cystoscopy Botox Injections
NCT ID: NCT04448171
Last Updated: 2025-08-20
Study Results
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View full resultsBasic Information
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TERMINATED
NA
42 participants
INTERVENTIONAL
2020-10-28
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Activated TENS Unit with standard pain control measures
Activated TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Active TENS
Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an active setting.
Sham TENS Unit with standard pain control measures
Sham TENS Unit with standard pain control measures during Office Based Cystoscopic Intra-detrusor Onabotulinumtoxin A Injection
Sham TENS
Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an inactive setting.
Interventions
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Active TENS
Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an active setting.
Sham TENS
Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an inactive setting.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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John A. Occhino
Associate Professor of Obstetrics and Gynecology
Principal Investigators
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John A Occhino, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20-003510
Identifier Type: -
Identifier Source: org_study_id
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