Clinical trial NCT06369922: TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Official title: Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Incontinence Female
Urinary Incontinence
Urinary Incontinence,Stress
Pain
Pain Acute
Keywords: TENS
pain
Transcutaneous Electrical Nerve Stimulation Analgesia
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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

Primary outcomes:
measure: Mean pain measured by Visual Analog Scale (VAS)
timeFrame: Before procedure
measure: Mean pain measured by Visual Analog Scale (VAS)
timeFrame: Approximately 2-5 minutes into the procedure
measure: Mean pain measured by Visual Analog Scale (VAS)
timeFrame: within 10 minutes after procedure
Secondary outcomes:
measure: Mean pain measured by Likert scale
timeFrame: before procedure
measure: Mean pain measured by Likert scale
timeFrame: Approximately 2-5 minutes into the procedure
measure: Mean pain measured by Likert scale
timeFrame: within 10 minutes after procedure
measure: Number of participants with side effects
timeFrame: within 10 minutes after procedure
measure: Mean satisfaction with the procedure
timeFrame: within 10 minutes after procedure
measure: TENS or NO TENS
timeFrame: within 10 minutes after procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Pelvic Health and Continence Specialties
state: New York
Study officials:
References: