Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Rochester
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Mean pain measured by Visual Analog Scale (VAS)
Study Overview
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:
- A discrete 5-point Likert Scale to assess the internal consistency of the pain rating within the study
- A satisfaction 10-point scale questionnaire
- 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),
- Length of procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Active TENS
In the active treatment group, the TENS unit will remain on up to 30 minutes (10 minutes pre-procedure, during the procedure and during the questionnaires).
Intervention: TENS (Procedure)
Control TENS
The sham stimulation group will undergo the same procedure; however, the TENS stimulation current will be reduced to a minimal detectable level and turned off after 20 seconds.
Intervention: Control TENS (Procedure)
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.
Mean pain measured by Visual Analog Scale (VAS)
Time Frame: 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.
Mean pain measured by Visual Analog Scale (VAS)
Time Frame: Approximately 2-5 minutes into the 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
- TENS or NO TENS(within 10 minutes after procedure)
- Mean pain measured by Likert scale(within 10 minutes after procedure)
- Mean satisfaction with the procedure(within 10 minutes after procedure)
- Number of participants with side effects(within 10 minutes after procedure)
- Mean pain measured by Likert scale(before procedure)
- Mean pain measured by Likert scale(Approximately 2-5 minutes into the procedure)
Investigators
Jared Matthew Floch
Fellow
University of Rochester