TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence. (TENSUB)

University of Rochester

Status: Enrolling

Conditions: Pain Acute; Pain; Urinary Incontinence,Stress; Urinary Incontinence; Stress Incontinence Female

Treatments: Procedure: Control TENS; Procedure: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT06369922

STUDY00009315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Active TENS

Experimental group

Description:

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).

Treatment:

Procedure: TENS

Control TENS

Sham Comparator group

Description:

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.

Treatment:

Procedure: Control TENS