Urinary Incontinence, Overactive Bladder, Pain, Acute
Conditions
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.
Interventions
PROCEDURETENS
This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (procedure typically will take from 5-15 minutes). The TENS units have pre-program settings improving convenience, reproducibility and reliability. Study staff will be instructed to perform TENS using an Acupuncture mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.
PROCEDUREControl TENS
This device will then be used for deep transcutaneous nerve stimulation at the T10-L1 and S2-S4 levels. The device will be placed and activated 5 minutes before the procedure. and the device will remain active during the procedure and will be turned off as soon as the procedure is complete (procedure typically will take from 5-15 minutes). The TENS units have pre-program settings improving convenience, reproducibility and reliability. Study staff will be instructed to perform TENS using an Acupuncture mode on the provided TENS units. The amplitude will be adjusted to a comfortable sensation that does not cause pain using adhesive electrodes. One TENS unit is able to support 4 TENS electrodes. The TENS electrodes (8 cm x 5 cm) will be placed on bilateral paraspinal muscles. The intensity of the stimulation (Hz) will be adjusted to the subjective comfort of the subject.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean pain measured by Visual Analog Scale (VAS) | Baseline (Before 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
| Measure | Time frame | Description |
|---|---|---|
| Mean pain measured by Likert scale | before procedure | 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 |
| Number of participants with side effects | within 10 minutes after procedure | 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. |
| Mean satisfaction with the procedure | within 10 minutes after procedure | A 1-10 point satisfaction scale will be used where 10 indicates higher satisfaction. |
| Number of participants who guessed correctly whether they were given the active TENS or placebo TENS | within 10 minutes after procedure | — |
Countries
United States
Outcome results
None listed