Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Operative Cystoscopy for Overactive Bladder: A Randomized Control Trial (TENSOB Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- University of Rochester
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Mean pain measured by Visual Analog Scale (VAS)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Subjects will be identified by the University of Rochester Urologists and Urogynecologists participating in the study who currently oversee urinary urge incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia and the second group will have cystoscopy with placebo TENS.
Investigators
Paula Doyle
Professor
University of Rochester
Eligibility Criteria
Inclusion Criteria
- •Men and Women, Age ≥18 years
- •Diagnosis of OAB/UUI,
- •Scheduled to undergo intravesical Botox injections in the office
- •Able to read/write English
- •Exclusion criteria:
- •Currently undergoing Sacral Neuromodulation
- •Cutaneous damage such as ulcers or broken skin on target treatment area
- •Currently implanted cardiac pacemaker or defibrillator
- •Pre-procedural use of opioids for pain management, less than 8 hours from last dose
- •Participants with altered sensation below the umbilicus
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean pain measured by Visual Analog Scale (VAS)
Time Frame: within 10 minutes after procedure
The VAS for pain consists of a 100-mm-long horizontal line where 0-mm equals no pain and 100-mm equals worst possible pain.
Secondary Outcomes
- Mean pain measured by Likert scale(within 10 minutes after procedure)
- Number of participants with side effects(within 10 minutes after procedure)
- Mean satisfaction with the procedure(within 10 minutes after procedure)
- Number of participants who guessed correctly whether they were given the active TENS or placebo TENS(within 10 minutes after procedure)