TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TENS, Control TENS.
- Who it may be relevant to
- Registry conditions: Stress Incontinence Female, Urinary Incontinence, Urinary Incontinence,Stress, Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Overview
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
- Procedure 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 "Acupunc - Procedure Control 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 "Acupunc
Primary outcome measures
- Mean pain measured by Visual Analog Scale (VAS) [Time frame: Before procedure]
- Mean pain measured by Visual Analog Scale (VAS) [Time frame: Approximately 2-5 minutes into the procedure]
- Mean pain measured by Visual Analog Scale (VAS) [Time frame: within 10 minutes after procedure]
Secondary outcome measures (6)
- Mean pain measured by Likert scale [Time frame: before procedure]
- Mean pain measured by Likert scale [Time frame: Approximately 2-5 minutes into the procedure]
- Mean pain measured by Likert scale [Time frame: within 10 minutes after procedure]
- Number of participants with side effects [Time frame: within 10 minutes after procedure]
- Mean satisfaction with the procedure [Time frame: within 10 minutes after procedure]
- TENS or NO TENS [Time frame: within 10 minutes after procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Pelvic Health and Continence Specialties — Rochester
Identifiers
NCT: NCT06369922 · STUDY00009315