TENS for Stress Urinary Incontinence (TENSUB Trial)

N/A

Recruiting

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2-5 minutes into the procedure

Summary

This trial will involve women with stress urinary incontinence undergoing a bulking procedure. They will be randomly assigned to two groups: one group will receive electrical nerve stimulation for pain relief during the procedure,

Who is the study for?

This trial is for women with stress urinary incontinence scheduled for an outpatient urethral bulking procedure. Participants will be under the care of University of Rochester Urologists and Urogynecologists involved in the study.

What is being tested?

The study is testing if TENS, a method using electrical nerve stimulation, can reduce pain during cystoscopy compared to placebo (fake) TENS. Women are randomly assigned to one of these two groups without knowing which one they're getting.

What are the potential side effects?

TENS is generally safe but may cause skin irritation at the site of electrode placement or discomfort from the electrical current. Placebo TENS has no active components, so any side effects would likely be minimal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2-5 minutes into the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2-5 minutes into the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2-5 minutes into the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean pain measured by Visual Analog Scale (VAS)

Secondary study objectives

Mean pain measured by Likert scale

Mean satisfaction with the procedure

Number of participants with side effects

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active TENSExperimental Treatment1 Intervention

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).

Group II: Control TENSPlacebo Group1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

TENS

2011

Completed Phase 2

~2040

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