TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Women, Age ≥18 years
Diagnosis of SUI
Scheduled to undergo transurethral bulking in the office
Able to read/write English
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
TENS
Procedure/SurgeryThis 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.
Control TENS
Procedure/SurgeryThis 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Active TENSExperimental treatment 1 intervention
Group B: Control TENSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Before procedure2
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.
Time frame
Approximately 2-5 minutes into the procedure3
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.
Time frame
within 10 minutes after procedureSecondary outcomes
1
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
Time frame
before procedure2
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
Time frame
Approximately 2-5 minutes into the procedure3
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
Time frame
within 10 minutes after procedure4
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.
Time frame
within 10 minutes after procedureSponsors and contacts
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Source ClinicalTrials.gov