Urinary Incontinence Clinical Trial
— TENSOBOfficial title:
Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Operative Cystoscopy for Overactive Bladder: A Randomized Control Trial (TENSOB Study)
Verified date | April 2022 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 3, 2022 |
Est. primary completion date | March 3, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean pain measured by Visual Analog Scale (VAS) | 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. | Baseline (Before procedure) | |
Primary | Mean pain measured by Visual Analog Scale (VAS) | 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. | Approximately 2-5 minutes into the procedure | |
Primary | Mean pain measured by Visual Analog Scale (VAS) | 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. | within 10 minutes after procedure | |
Secondary | Mean pain measured by Likert scale | A discrete, 5-point verbal Likert scale including the following options: "no pain", "minimal pain", "moderate pain", "severe pain" and "worst pain possible" will be asked to patients | before procedure | |
Secondary | Mean pain measured by Likert scale | A discrete, 5-point verbal Likert scale including the following options: "no pain", "minimal pain", "moderate pain", "severe pain" and "worst pain possible" will be asked to patients | Approximately 2-5 minutes into the procedure | |
Secondary | Mean pain measured by Likert scale | A discrete, 5-point verbal Likert scale including the following options: "no pain", "minimal pain", "moderate pain", "severe pain" and "worst pain possible" will be asked to patients | within 10 minutes after procedure | |
Secondary | Number of participants with side effects | A check list of vasovagal symptoms will be handed to the study team member to complete if the subject reports any light headedness, nausea or sweating. | within 10 minutes after procedure | |
Secondary | Mean satisfaction with the procedure | A 1-10 point satisfaction scale will be used where 10 indicates higher satisfaction. | within 10 minutes after procedure | |
Secondary | Number of participants who guessed correctly whether they were given the active TENS or placebo TENS | within 10 minutes after procedure |
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