Stress Incontinence Female, Urinary Incontinence, Urinary Incontinence,Stress, Pain, Pain Acute
Conditions
Keywords
TENS, pain, Transcutaneous Electrical Nerve Stimulation Analgesia
Brief summary
This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress 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 the cystoscopy with placebo TENS.
Detailed description
This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing outpatient transurethral bulking procedures. These subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study, who oversee the patient's stress urinary incontinence management. The subjects will be asked to participate in this research project when the doctor is offering options for their SUI treatment. Subjects will be randomized into two groups. One group will undergo transurethral bulking with TENS for analgesia, and the second group will have the procedure performed with placebo TENS. The application of the TENS device will be performed by a study team member who will know to what group the patient was randomized. Both groups will be given the VAS, satisfaction scale, and 5-point Likert scale questionnaires to be answered before, during, and after they undergo treatment on the scheduled day of the procedure. The primary outcome will be a change in the VAS pain measurement. Investigators hypothesized that TENS used during transurethral bulking injections would result in a 10-mm decrease in VAS compared to placebo TENS. Secondary outcomes will be: 1. A discrete 5-point Likert Scale to assess the internal consistency of the pain rating within the study 2. A satisfaction 10-point scale questionnaire 3. Rate of side effects to the use of TENS (skin irritation, pain or burning at electrode site) and transurethral bulking injections (vasovagal symptoms: dizziness, nausea, vomiting, shoulder pain, vertigo, sweating, fainting), 4. Length of procedure.
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 (the procedure typically takes 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 (the procedure typically takes 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
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Women, Age ≥18 years * Diagnosis of SUI * Scheduled to undergo transurethral bulking in the office * Able to read/write English
Exclusion criteria
* • 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) | 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. |
| TENS or NO TENS | within 10 minutes after procedure | Number of participants who guessed correctly whether they were given the active TENS or placebo TENS |
Countries
United States
Contacts
Primary ContactJared M Floch, DO, MS
Backup ContactDiego Hernandez-Aranda, MD
Outcome results
None listed