Nerve Stimulation Using a TENS to Provide Pain Relief During Surgery for Overactive Bladder (TENSOB)

University of Rochester

Status: Completed

Conditions: Pain, Acute; Urinary Incontinence; Overactive Bladder

Treatments: Procedure: Control TENS; Procedure: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT05330117

STUDY00005257

Details and patient eligibility

About

This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Subjects will be identified by the University of Rochester Urologists and Urogynecologists participating in the study who currently oversee urinary urge 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 cystoscopy with placebo TENS.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and Women, Age ≥18 years
• Diagnosis of OAB/UUI,
• Scheduled to undergo intravesical Botox injections in the office
• Able to read/write English

Exclusion criteria

• Currently undergoing Sacral Neuromodulation
• 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