TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Официальное название

Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• Mean pain measured by Visual Analog Scale (VAS) [Срок оценки: Before procedure]
• Mean pain measured by Visual Analog Scale (VAS) [Срок оценки: Approximately 2-5 minutes into the procedure]
• Mean pain measured by Visual Analog Scale (VAS) [Срок оценки: within 10 minutes after procedure]

Вторичные конечные точки (6)

• Mean pain measured by Likert scale [Срок оценки: before procedure]
• Mean pain measured by Likert scale [Срок оценки: Approximately 2-5 minutes into the procedure]
• Mean pain measured by Likert scale [Срок оценки: within 10 minutes after procedure]
• Number of participants with side effects [Срок оценки: within 10 minutes after procedure]
• Mean satisfaction with the procedure [Срок оценки: within 10 minutes after procedure]
• TENS or NO TENS [Срок оценки: within 10 minutes after procedure]

Критерии участия

Критерии включения

• • Women, Age ≥18 years

• Diagnosis of SUI
• Scheduled to undergo transurethral bulking in the office
• Able to read/write English

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Pelvic Health and Continence Specialties — Rochester

Идентификаторы

NCT: NCT06369922 · STUDY00009315

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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