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Behavioural Intervention

Active TENS for Stress Incontinence (TENSUB Trial)

N/A
Waitlist Available
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 within 10 minutes after procedure
Awards & highlights

TENSUB Trial 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.Check my eligibility
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.See study design
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.

TENSUB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 10 minutes after procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 10 minutes after procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean pain measured by Visual Analog Scale (VAS)
Secondary outcome measures
Mean pain measured by Likert scale
Mean satisfaction with the procedure
Number of participants with side effects
+1 more

TENSUB 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

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
840 Previous Clinical Trials
534,150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being recruited for this ongoing medical study?

"As per information on clinicaltrials.gov, the ongoing trial is not presently seeking subjects. It was first listed on 1st July 2024 and last revised on 12th April 2024. Although this specific trial isn't recruiting, there are currently opportunities to participate in other studies, with a total of 584 trials open for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.
Jared Matthew Floch 2024. "TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06369922.
All > Urinary Incontinence
~67 spots leftby Mar 2026
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